MAUDE Adverse Event Report: ABBOTT MEDICAL AMPLATZER VASCULAR PLUG III; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION

Catalog Number UNK AMPLATZERVASCULARPLUG III

Device Problems Migration or Expulsion of Device (1395); Patient Device Interaction Problem (4001)

Patient Problems Stroke/CVA (1770); Endocarditis (1834); Hemorrhage/Bleeding (1888); Cardiac Tamponade (2226); Heart Failure/Congestive Heart Failure (4446); Aortic Valve Insufficiency/ Regurgitation (4450)

Event Date 01/01/2018

Event Type  Injury  

Manufacturer Narrative

Literature article: percutaneous paravalvular leak closure after transcatheter aortic valve implantation: the international plugintavi registry.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

The article, ¿percutaneous paravalvular leak closure after transcatheter aortic valve implantation: the international plugintavi registry¿, was reviewed.The article presents a retrospective, multicenter experience aimed to present a large multicenter international experience of percutaneous post- transcatheter aortic valve implantation (tavi) paravalvular leak (pvl) closure.Devices in this study included amplatzer vascular plug iii (avp-3; abbott), amplatzer vascular plug 4 (avp-4; abbott), occlutech pld devices (occlutech).The article concluded percutaneous pvl closure is a feasible and safe option for treating post-tavi leaks.Successful pvl reduction to mild or less could be associated with acute and long-lasting improvements in clinical outcomes.[the primary author is eduardo flores-umanzor, peter munk cardiac centre, toronto general hospital, university health network (uhn), toronto, on, canada; the corresponding author is xavier freixa, hospital clinic de barcelona, institut clinic cardiovascular, idibaps, barcelona, spain, with corresponding email: freixa@clinic.Cat].The time frame of the study was from january 2018 and october 2022.A total of 45 patients were included in this study.The average age was 80 years, and the average gender was male.Comorbidities included diabetes, hypertension, atrial fibrillation, pervious cad, previous ischemic stroke, previous peripheral artery disease, chronic kidney disease, liver disease, heart failure, hemolysis, paravalvular aortic regurgitation, mitral regurgitation, and tricuspid regurgitation.

Manufacturer Narrative

Summarized patient outcomes/complications of amplatzer vascular plug were reported in a research article in a subject population with multiple co-morbidities including diabetes, hypertension, atrial fibrillation, pervious cad, previous ischemic stroke, previous peripheral artery disease, chronic kidney disease, liver disease, heart failure, hemolysis, paravalvular aortic regurgitation, mitral regurgitation, and tricuspid regurgitation.Some of the complications reported were migration/expulsion of device, aortic valve insufficiency/regurgitation, cardiac tamponade, stroke/cva, hemorrhage/blood loss/bleeding, heart failure/congestive heart failure, and endocarditis; these complications are anticipated for the procedure and subject population.A more comprehensive assessment could not be performed as the event was non-contemporaneously reported through a literature review and no device or individual patient information was received for analysis. .

• Brand Name: AMPLATZER VASCULAR PLUG III
• Type of Device: DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane n; plymouth MN 55442
• Manufacturer (Section G): ABBOTT MEDICAL REG# 2135147; 5050 nathan ln n; plymouth MN 55442
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 17343008
• MDR Text Key: 319371920
• Report Number: 2135147-2023-03079
• Device Sequence Number: 1
• Product Code: KRD
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/18/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK AMPLATZERVASCULARPLUG III
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/17/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Disability; Required Intervention