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

Catalog Number UNKAMPLATZERMUSCULARVSDOCCLUD

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Hematoma (1884); Ischemia (1942); Heart Block (4444); Tricuspid Valve Insufficiency/ Regurgitation (4453)

Event Date 03/01/2021

Event Type  Injury  

Event Description

The article, "transcatheter versus surgical closure of ventricular septal defect: a comparative study", was reviewed.The article presented a prospective, multicenter study to compare the safety, efficacy, and clinical effects of surgical versus transcatheter closure of a ventricular septal defect.Devices included in this study were amplatzer duct occluder, amplatzer duct occluder ii, amplatzer muscular vsd occluder, cera membrane vsd occluder, konar-mf vsd occluder, and cera pda occluder.The article concluded that both transcatheter device closure and surgical repair are effective treatments.In contrast, the psychological profile of the transcatheter device was superior to the surgical repair, especially in terms of avoiding sternotomy scar, blood loss and transfusion, and hospital stay.On the other hand, transcatheter intervention is limited only to the anatomically suitable ventricular septal defects, in addition, surgical backup is a must in case of complicated transcatheter closure, which gives the upper hand to surgery to be the recommended approach for most of the ventricular septal defects.[the primary author was hamdy singab, academic institute of cardiac surgery, ain-shams university, cairo, egypt.The corresponding author was mohamed khairat elshahat, national heart institute, giza, egypt, with corresponding email: abokhirte@gmail.Com].The time frame of the study was from (b)(6) 2021 to (b)(6) 2022.A total of 72 patients were included in this study where 36 received transcatheter closure of ventricular septal defect (the other 36 underwent surgical closure).Of the 36 patients who received transcatheter closure, 61% received an abbott device.In group ii (transcatheter closure only), the average age was 5.35 years and the gender ratio was evenly split.Comorbidities included ventricular septal defect (perimembranous or muscular), regurgitation (mitral/aortic/tricuspid).

Manufacturer Narrative

Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.Literature attachment: article title "transcatheter versus surgical closure of ventricular septal defect: a comparative study.

Manufacturer Narrative

Summarized patient outcomes/complications of amplatzer muscular vsd occluder were reported in a research article in a subject population with multiple co-morbidities including ventricular septal defect (peri membranous or muscular), regurgitation (mitral/aortic/tricuspid).Some of the complications reported were complete heart block, permanent pacemaker implant (surgical intervention), tricuspid regurgitation, hematoma, peripheral ischemia and residual shunt.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 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: 18721355
• MDR Text Key: 335583892
• Report Number: 2135147-2024-00716
• Device Sequence Number: 1
• Product Code: MLV
• Combination Product (y/n): N
• Reporter Country Code: EG
• PMA/PMN Number: P040040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2024
• 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
• Date Manufacturer Received: 02/20/2024
• 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): Required Intervention