| 000 | 04899nam a22007337a 4500 | ||
|---|---|---|---|
| 008 | 190521s20192019 xxu||||| |||| 00| 0 eng d | ||
| 022 | _a1878-0938 | ||
| 024 | _a10.1016/j.carrev.2019.02.016 [doi] | ||
| 024 | _aS1553-8389(19)30149-6 [pii] | ||
| 040 | _aOvid MEDLINE(R) | ||
| 099 | _a31079818 | ||
| 245 | _aAdverse Events Associated with the Use of Guide Extension Catheters during Percutaneous Coronary Intervention: Reports from the Manufacturer and User Facility Device Experience (MAUDE) database. | ||
| 251 | _aCardiovascular Revascularization Medicine. 20(5):409-412, 2019 05. | ||
| 252 | _aCardiovasc Revasc Med. 20(5):409-412, 2019 05. | ||
| 252 | _zCardiovasc Revasc Med. 20(5):409-412, 2019 May. | ||
| 253 | _aCardiovascular revascularization medicine : including molecular interventions | ||
| 260 | _c2019 | ||
| 260 | _fFY2019 | ||
| 265 | _sppublish | ||
| 266 | _d2019-05-21 | ||
| 268 | _aCardiovascular Revascularization Medicine. 20(5):409-412, 2019 May. | ||
| 501 | _aAvailable in print through MWHC library: 2002 - present | ||
| 520 | _aBACKGROUND/PURPOSE: We aimed to assess the reported complications and event modes for the GuideLiner and Guidezilla extension catheters. | ||
| 520 | _aCONCLUSIONS: Findings from the MAUDE database highlight the complications and modes of events associated with the use of GuideLiner and Guidezilla extension catheters. | ||
| 520 | _aCopyright (c) 2019 Elsevier Inc. All rights reserved. | ||
| 520 | _aMETHODS/MATERIALS: The US Food and Drug Administration (FDA) Manufacturer and User Facility Device Experience (MAUDE) database was queried for reported events. | ||
| 520 | _aRESULTS: Of the 65 cases with reported GuideLiner-related issues, 15 (23%) involved the inability to pass equipment through or damage to percutaneous coronary intervention (PCI) devices in the GuideLiner catheter, 38 (58%) involved GuideLiner catheter fracture, 9 (14%) involved coronary artery dissection, 2 (3%) involved coronary artery perforation, and 1 (1.5%) involved thrombus formation in the catheter. Of the 408 cases with reported Guidezilla-related issues, 53 (13%) involved inability to pass or damaged PCI devices into the Guidezilla catheter, 117 (29%) involved inability to advance the Guidezilla catheter to the target lesion, 59 (14%) involved kinked Guidezilla catheter, mostly because of partial or complete catheter fracture upon further investigation, 164 (40%) involved a broken Guidezilla catheter, 10 (2.5%) involved coronary artery dissection, 2 (0.5%) involved coronary artery perforation, 1 (0.2%)involved aortic dissection, 1 (0.2%) involved thrombosis formation, and 1 (0.2%) involved no-reflow phenomenon. | ||
| 520 | _aSUMMARY: To assess the reported complications and event modes for the GuideLiner and Guidezilla extension catheters, the US Food and Drug Administration (FDA) Manufacturer and User Facility Device Experience (MAUDE) database was queried. There were more reports on Guidezilla-related events during the search period. The events for both extension catheters mainly involved the inability to pass equipment through or damage to percutaneous coronary intervention (PCI) devices in the extension catheter, extension catheter fracture, coronary artery dissection and perforation and, occasionally, the death of the patients. | ||
| 546 | _aEnglish | ||
| 650 | _a*Cardiac Catheters/ae [Adverse Effects] | ||
| 650 | _a*Coronary Artery Disease/th [Therapy] | ||
| 650 | _a*Percutaneous Coronary Intervention/ae [Adverse Effects] | ||
| 650 | _a*Percutaneous Coronary Intervention/is [Instrumentation] | ||
| 650 | _a*Product Surveillance, Postmarketing | ||
| 650 | _aCoronary Artery Disease/dg [Diagnostic Imaging] | ||
| 650 | _aCoronary Artery Disease/mo [Mortality] | ||
| 650 | _aDatabases, Factual | ||
| 650 | _aEquipment Design | ||
| 650 | _aEquipment Failure | ||
| 650 | _aHumans | ||
| 650 | _aPercutaneous Coronary Intervention/mo [Mortality] | ||
| 650 | _aRisk Assessment | ||
| 650 | _aRisk Factors | ||
| 650 | _aTreatment Outcome | ||
| 650 | _aUnited States | ||
| 650 | _aUnited States Food and Drug Administration | ||
| 651 | _aMedStar Heart & Vascular Institute | ||
| 657 | _aJournal Article | ||
| 700 | _aBernardo, Nelson L | ||
| 700 | _aChen, Yuefeng | ||
| 700 | _aGajanana, Deepakraj | ||
| 700 | _aHashim, Hayder | ||
| 700 | _aIantorno, Micaela | ||
| 700 | _aKhalid, Nauman | ||
| 700 | _aKhan, Jaffar M | ||
| 700 | _aMusallam, Anees | ||
| 700 | _aRogers, Toby | ||
| 700 | _aShah, Arhum A | ||
| 700 | _aShlofmitz, Evan | ||
| 700 | _aWaksman, Ron | ||
| 790 | _aBernardo NL, Chen Y, Gajanana D, Hashim H, Iantorno M, Khalid N, Khan JM, Musallam A, Rogers T, Shah AA, Shlofmitz E, Waksman R | ||
| 856 |
_uhttps://dx.doi.org/10.1016/j.carrev.2019.02.016 _zhttps://dx.doi.org/10.1016/j.carrev.2019.02.016 |
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| 942 |
_cART _dArticle |
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| 999 |
_c4237 _d4237 |
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