Adverse events and modes of failure related to the FilterWire EZ Embolic Protection System: Lessons learned from an analytic review of the FDA MAUDE database.

MedStar author(s):
Citation: Catheterization & Cardiovascular Interventions. 94(1):157-164, 2019 Jul 01.PMID: 30985082Institution: MedStar Heart & Vascular InstituteForm of publication: Journal ArticleMedline article type(s): Journal ArticleSubject headings: *Carotid Stenosis/th [Therapy] | *Cerebrovascular Disorders/et [Etiology] | *Embolic Protection Devices | *Embolism/pc [Prevention & Control] | *Endovascular Procedures/is [Instrumentation] | *Graft Occlusion, Vascular/th [Therapy] | *Heart Diseases/et [Etiology] | *Product Surveillance, Postmarketing | *Prosthesis Failure | *Saphenous Vein/tr [Transplantation] | *United States Food and Drug Administration | Carotid Stenosis/dg [Diagnostic Imaging] | Coronary Artery Bypass/ae [Adverse Effects] | Databases, Factual | Embolism/et [Etiology] | Endovascular Procedures/ae [Adverse Effects] | Equipment Failure Analysis | Graft Occlusion, Vascular/dg [Diagnostic Imaging] | Graft Occlusion, Vascular/et [Etiology] | Humans | Prosthesis Design | Risk Factors | Saphenous Vein/dg [Diagnostic Imaging] | United StatesYear: 2019Local holdings: Available online from MWHC library: 1996 - present, Available in print through MWHC library: 1996 - 2006ISSN:
  • 1522-1946
Name of journal: Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & InterventionsAbstract: BACKGROUND: EPDs prevent distal embolization of atheroembolic materials during percutaneous interventions resulting in reduced microvascular obstruction and improved microcirculation while maintaining tissue perfusion. The FilterWire EZ EPD (Boston Scientific, Natick, MA) is approved for use in interventions of de novo saphenous vein grafts (SVG) and carotid artery stenosis. Robust data on the commonly reported complications and failure modes associated with the FilterWire EZ device are limited.CONCLUSIONS: Analysis of the MAUDE dataset is helpful in identifying the commonly reported adverse events and failure modes of FilterWire EZ devices. This platform serves as an important tool for both physicians and manufacturers to optimize device performance and clinical outcomes.Copyright (c) 2019 Wiley Periodicals, Inc.METHODS: The MAUDE database was queried from September 1, 2008, through September 30, 2018, for FilterWire EZ system, yielding 474 reports. After exclusion of duplicate and incomplete reports, 464 device reports were included in the final analysis.OBJECTIVES: To assess the commonly reported complications and failure modes for FilterWire EZ Embolic Protection Devices (EPD) by analyzing the postmarketing surveillance data from the Food and Drug Administration (FDA) Manufacturer and User Facility Device Experience (MAUDE) database.RESULTS: Device-related adverse events were most commonly reported for carotid (n = 281) and SVG (n = 101) interventions. The most commonly reported major complications were: ischemic stroke (n = 57), vessel perforation or dissection (n = 12), death (n = 8), and myocardial infarction (n = 5). Minor complications included: hypotension (n = 68), bradycardia (n = 41), and vasospasm (n = 27). The most commonly reported failure modes were: detachment and/or damage of the device components (n = 118), device entrapment (n = 90), and stent-related issues (n = 46).All authors: Bernardo NL, Chen Y, Hashim H, Javed H, Khalid N, Khan JM, Musallam A, Rogers T, Shlofmitz E, Torguson R, Waksman ROriginally published: Catheterization & Cardiovascular Interventions. 94(1):157-164, 2019 Jul 01.Fiscal year: FY2020Digital Object Identifier: ORCID: Date added to catalog: 2019-05-21
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Item type Current library Collection Call number Status Date due Barcode
Journal Article MedStar Authors Catalog Article 30985082 Available 30985082

Available online from MWHC library: 1996 - present, Available in print through MWHC library: 1996 - 2006

BACKGROUND: EPDs prevent distal embolization of atheroembolic materials during percutaneous interventions resulting in reduced microvascular obstruction and improved microcirculation while maintaining tissue perfusion. The FilterWire EZ EPD (Boston Scientific, Natick, MA) is approved for use in interventions of de novo saphenous vein grafts (SVG) and carotid artery stenosis. Robust data on the commonly reported complications and failure modes associated with the FilterWire EZ device are limited.

CONCLUSIONS: Analysis of the MAUDE dataset is helpful in identifying the commonly reported adverse events and failure modes of FilterWire EZ devices. This platform serves as an important tool for both physicians and manufacturers to optimize device performance and clinical outcomes.

Copyright (c) 2019 Wiley Periodicals, Inc.

METHODS: The MAUDE database was queried from September 1, 2008, through September 30, 2018, for FilterWire EZ system, yielding 474 reports. After exclusion of duplicate and incomplete reports, 464 device reports were included in the final analysis.

OBJECTIVES: To assess the commonly reported complications and failure modes for FilterWire EZ Embolic Protection Devices (EPD) by analyzing the postmarketing surveillance data from the Food and Drug Administration (FDA) Manufacturer and User Facility Device Experience (MAUDE) database.

RESULTS: Device-related adverse events were most commonly reported for carotid (n = 281) and SVG (n = 101) interventions. The most commonly reported major complications were: ischemic stroke (n = 57), vessel perforation or dissection (n = 12), death (n = 8), and myocardial infarction (n = 5). Minor complications included: hypotension (n = 68), bradycardia (n = 41), and vasospasm (n = 27). The most commonly reported failure modes were: detachment and/or damage of the device components (n = 118), device entrapment (n = 90), and stent-related issues (n = 46).

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