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

Catalog Number UNK AMPLATZER VASCULAR PLUG

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Stroke/CVA (1770); Endocarditis (1834); Hemorrhage/Bleeding (1888); Hemothorax (1896); Perforation (2001); Pleural Effusion (2010); Renal Failure (2041); Cardiac Tamponade (2226); Obstruction/Occlusion (2422)

Event Date 01/01/2002

Event Type  Death  

Event Description

The article, "transcatheter closure or surgery for symptomatic paravalvular leaks: the multicenter kiss registry", was reviewed.The article presented a retrospective, multicenter study to evaluate the long-term outcomes of the patients who underwent reoperation or transcatheter closure (tc) of paravalvular leaks (pvls).Devices included amplatzer vascular plug ii, amplatzer vascular plug iii, amplatzer vascular plug iv, amplatzer ductal occluder ii, amplatzer muscular ventricular septal occluder, amplatzer septal occluder, and occlutech.The article concluded that the current data suggest that percutaneous closure of pvl was associated with lower early and comparable long-term mortality rates compared with surgery.[the primary and corresponding author was ahmet guner, istanbul mehmet akif ersoy thoracic and cardiovascular surgery training and research hospital, department of cardiology, turgut özal bulvari no:11, 34303, kucukcekmece, istanbul, turkey, with corresponding email: ahmetguner488@gmail.Com] the time frame of the study was from january 2002 to december 2021.A total of 335 patients were included in the study, of which 93% received an abbott device.The average age was 58.15 years and the average gender was male.Comorbidities included hypertension, atrial fibrillation, diabetes, hyperlipidemia, prior percutaneous coronary intervention, prior coronary artery bypass graft, chronic kidney disease, heart failure, prior endocarditis, chronic pulmonary disease, prior reoperation, history of stroke, smoker, and hemolysis.

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 hypertension, atrial fibrillation, diabetes, hyperlipidemia, prior percutaneous coronary intervention, prior coronary artery bypass graft, chronic kidney disease, heart failure, prior endocarditis, chronic pulmonary disease, prior reoperation, history of stroke, smoker, and hemolysis.Some of the peri- and post-procedural complications reported were death, stroke, acute kidney injury, pneumonia, cardiac tamponade, pleural effusion, effusion drainage (unexpected medical intervention), hemothorax, coronary obstruction, cardiac rupture, bleeding, endocarditis, rehospitalization, and reintervention (surgical intervention); 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.Based on the information received, the cause of the reported incident could not be conclusively determined.Literature attachment: article title "transcatheter closure or surgery for symptomatic paravalvular leaks: the multicenter kiss registry".

• Brand Name: AMPLATZER VASCULAR PLUG
• 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: 18583320
• MDR Text Key: 333755345
• Report Number: 2135147-2024-00360
• Device Sequence Number: 1
• Product Code: KRD
• Combination Product (y/n): N
• Reporter Country Code: TU
• PMA/PMN Number: K031810
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK AMPLATZER VASCULAR PLUG
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/02/2024
• 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): Death