MARC details
| 000 -LEADER |
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| fixed length control field |
03852nam a22006377a 4500 |
| 008 - FIXED-LENGTH DATA ELEMENTS--GENERAL INFORMATION |
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| fixed length control field |
210217s20202020 xxu||||| |||| 00| 0 eng d |
| 022 ## - INTERNATIONAL STANDARD SERIAL NUMBER |
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| International Standard Serial Number |
1878-0938 |
| 024 ## - OTHER STANDARD IDENTIFIER |
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| Standard number or code |
10.1016/j.carrev.2020.11.023 [doi] |
| 024 ## - OTHER STANDARD IDENTIFIER |
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| Standard number or code |
S1553-8389(20)30773-9 [pii] |
| 040 ## - CATALOGING SOURCE |
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| Original cataloging agency |
Ovid MEDLINE(R) |
| 099 ## - LOCAL FREE-TEXT CALL NUMBER (OCLC) |
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| PMID |
33402323 |
| 245 ## - TITLE STATEMENT |
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| Title |
Real-World Experience of the MANTA Closure Device: Insights From the FDA Manufacturer and User Facility Device Experience (MAUDE) Database. |
| 251 ## - Source |
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| Source |
Cardiovascular Revascularization Medicine. 27:63-66, 2021 06. |
| 252 ## - Abbreviated Source |
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| Abbreviated source |
Cardiovasc Revasc Med. 27:63-66, 2021 06. |
| 252 ## - Abbreviated Source |
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| Former abbreviated source |
Cardiovasc Revasc Med. 2020 Nov 20 |
| 253 ## - Journal Name |
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| Journal name |
Cardiovascular revascularization medicine : including molecular interventions |
| 260 ## - PUBLICATION, DISTRIBUTION, ETC. |
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| Year |
2021 |
| 260 ## - PUBLICATION, DISTRIBUTION, ETC. |
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| Manufacturer |
FY2021 |
| 265 ## - SOURCE FOR ACQUISITION/SUBSCRIPTION ADDRESS [OBSOLETE] |
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| Publication status |
aheadofprint |
| 265 ## - SOURCE FOR ACQUISITION/SUBSCRIPTION ADDRESS [OBSOLETE] |
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| Publication status |
ppublish |
| 266 ## - Date added to catalog |
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| Date added to catalog |
2021-02-17 |
| 268 ## - Previous citation |
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| -- |
Cardiovascular Revascularization Medicine. 2020 Nov 20 |
| 269 ## - Original dates |
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| Original fiscal year |
FY2021 |
| 501 ## - WITH NOTE |
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| Local holdings |
Available in print through MWHC library: 2002 - present |
| 520 ## - SUMMARY, ETC. |
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| Abstract |
BACKGROUND/PURPOSE: The MANTA vascular closure device (VCD) is the first commercially available dedicated closure device for large-bore femoral arterial access site closure and was approved by the United States Food and Drug Administration (FDA) in February 2019. Real-world data on the most commonly reported complications and modes of failure associated with the MANTA closure device are limited. We analyzed post-marketing surveillance data from FDA's Manufacturer and User Facility Device Experience (MAUDE) database for the MANTA VCD (Teleflex, Wayne, Pennsylvania). |
| 520 ## - SUMMARY, ETC. |
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| Abstract |
CONCLUSIONS: Our analysis of the MAUDE database demonstrates that in real-world practice, the MANTA VCD was found to be associated with complications, including death, vascular injury, and difficulties with the device itself. Ongoing user education, proctoring, and pre-procedural patient selection are important to minimize risks associated with the MANTA VCD. Copyright (c) 2020. Published by Elsevier Inc. |
| 520 ## - SUMMARY, ETC. |
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| Abstract |
METHODS/MATERIALS: Post-marketing surveillance data from the FDA MAUDE database from February 2019 through March 2020 were analyzed, yielding 170 reports. |
| 520 ## - SUMMARY, ETC. |
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| Abstract |
RESULTS: Of the 170 reports of major complications involving MANTA devices, 141 reports involved either injury (136) or death (5) related to the device. Of the 141 reports, bleeding was the most common adverse outcome described (45), followed by vessel occlusion (30) and vessel dissection (21). Device malfunction incidents (29 reports) were reported in 4 main categories: failed deployment (16 reports), malposition of the collagen (9), insufficient information (3), and device dislocation (1). |
| 546 ## - LANGUAGE NOTE |
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| Language note |
English |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
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| Topical term or geographic name entry element |
*Vascular Closure Devices |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
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| Topical term or geographic name entry element |
Databases, Factual |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
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| Topical term or geographic name entry element |
Femoral Artery |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
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| Topical term or geographic name entry element |
Hemorrhage/et [Etiology] |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
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| Topical term or geographic name entry element |
Humans |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
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| Topical term or geographic name entry element |
Treatment Outcome |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
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| Topical term or geographic name entry element |
United States |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
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| Topical term or geographic name entry element |
United States Food and Drug Administration |
| 651 ## - SUBJECT ADDED ENTRY--GEOGRAPHIC NAME |
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| Institution |
MedStar Heart & Vascular Institute |
| 657 ## - INDEX TERM--FUNCTION |
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| Medline publication type |
Journal Article |
| 700 ## - ADDED ENTRY--PERSONAL NAME |
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| Local Authors |
Ben-Dor, Itsik |
| 700 ## - ADDED ENTRY--PERSONAL NAME |
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| Local Authors |
Case, Brian Christopher |
| 700 ## - ADDED ENTRY--PERSONAL NAME |
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| Local Authors |
Chezar-Azerrad, Chava |
| 700 ## - ADDED ENTRY--PERSONAL NAME |
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| Local Authors |
Forrestal, Brian John |
| 700 ## - ADDED ENTRY--PERSONAL NAME |
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| Local Authors |
Khalid, Nauman |
| 700 ## - ADDED ENTRY--PERSONAL NAME |
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| Local Authors |
Khan, Jaffar M |
| 700 ## - ADDED ENTRY--PERSONAL NAME |
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| Local Authors |
Kumar, Sant |
| 700 ## - ADDED ENTRY--PERSONAL NAME |
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| Local Authors |
Musallam, Anees |
| 700 ## - ADDED ENTRY--PERSONAL NAME |
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| Local Authors |
Rogers, Toby |
| 700 ## - ADDED ENTRY--PERSONAL NAME |
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| Local Authors |
Satler, Lowell F |
| 700 ## - ADDED ENTRY--PERSONAL NAME |
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| Local Authors |
Shlofmitz, Evan |
| 700 ## - ADDED ENTRY--PERSONAL NAME |
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| Local Authors |
Waksman, Ron |
| 700 ## - ADDED ENTRY--PERSONAL NAME |
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| Local Authors |
Yerasi, Charan Teja Reddy |
| 790 ## - Authors |
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| All authors |
Ben-Dor I, Case BC, Chezar-Azerrad C, Forrestal BJ, Khalid N, Khan JM, Kumar S, Musallam A, Rogers T, Satler LF, Shlofmitz E, Waksman R, Yerasi C |
| 856 ## - ELECTRONIC LOCATION AND ACCESS |
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| DOI |
<a href="https://dx.doi.org/10.1016/j.carrev.2020.11.023">https://dx.doi.org/10.1016/j.carrev.2020.11.023</a> |
| Public note |
https://dx.doi.org/10.1016/j.carrev.2020.11.023 |
| 942 ## - ADDED ENTRY ELEMENTS (KOHA) |
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| Koha item type |
Journal Article |
| Item type description |
Article |
