MAUDE Adverse Event Report: ABBOTT MEDICAL AMPLATZER MUSCULAR VSD OCCLUDER; TRANSCATHETER SEPTAL OCCLUDER

Catalog Number UNKAMPLATZERMUSCULARVSDOCCLUD

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

Patient Problems Hematoma (1884); Transient Ischemic Attack (2109); Obstruction/Occlusion (2422); Pseudoaneurysm (2605); Pericardial Effusion (3271)

Event Date 01/01/2010

Event Type  Injury  

Manufacturer Narrative

Literature article attached: impact of a successful percutaneous mitral paravalvular leak closure on long-term major clinical outcomes b3 - date of event is estimated.D4 - the udi number is not known as the part and lot numbers were not provided the additional patient effect of malfunction reported in the article is captured under a separate medwatch report.Summarized patient outcomes/complications of successful percutaneous mitral paravalvular leak (pvl) closure were reported in a research article "impact of a successful percutaneous mitral paravalvular leak closure on long-term major clinical outcomes", in a subject population with multiple co-morbidities including diabetes mellitus, heart failure, hemolysis, transfusion requirement, chronic kidney disease, cerebrovascular disease, chronic obstructive pulmonary disease, coronary artery disease, atrial fibrillation, prior endocarditis, mechanical prosthesis, prior multiple sternotomies, and prior paravalvular repair surgery.Some of the complications reported were device embolization, pericardial effusion, surgical intervention, transfusion requirement (unexpected medical requirement), pseudoaneurysm, hematoma, arteriovenous fistula, transient ischemic attack, leaflet impingement (obstruction); 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.There is no indication of a product quality issue with regards to manufacture design or labeling.

Event Description

The article, "impact of a successful percutaneous mitral paravalvular leak closure on long-term major clinical outcomes", was reviewed.The article presented a retrospective, single center study to describe the impact of successful percutaneous mitral paravalvular leak (pvl) closure on long-term outcomes.Amplatzer vascular plug iii, amplatzer vascular plug ii, amplatzer vascular plug iv, amplatzer ductal occluder, ventricular septal defect occluder, and non-abbott coils.The article concluded that a successful reduction in pvl to mild or absent is associated with improved rates of all cause death, cardiovascular death and heart failure hospitalizations (hfh).[the primary and corresponding author was (b)(6).The time frame of the study was from january 2010 to october 2021.A total of 90 patients were included in this study, of which 97.3% received an abbott device.The average age was 72.5 years and the average gender was female.Comorbidities included diabetes mellitus, heart failure, hemolysis, transfusion requirement, chronic kidney disease, cerebrovascular disease, chronic obstructive pulmonary disease, coronary artery disease, atrial fibrillation, prior endocarditis, mechanical prosthesis, prior multiple sternotomies, and prior paravalvular repair surgery.

• Brand Name: AMPLATZER MUSCULAR VSD OCCLUDER
• Type of Device: TRANSCATHETER SEPTAL OCCLUDER
• 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: 18359458
• MDR Text Key: 330910323
• Report Number: 2135147-2023-05586
• Device Sequence Number: 1
• Product Code: MLV
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: P040040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKAMPLATZERMUSCULARVSDOCCLUD
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/27/2023
• Initial Date FDA Received: 12/19/2023
• 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): Required Intervention