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

Model Number 9-VSD-MUSC-010

Device Problems Material Perforation (2205); Human-Device Interface Problem (2949)

Patient Problem Cardiac Perforation (2513)

Event Type  Injury  

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.

Event Description

It was reported through a research article titled, "periventricular closure of muscular ventricular septal defects in infants with echocardiographic guidance only" that between january 2006 and may 2010, eight infants with nine large muscular (apical) vsds underwent periventricular device closure in a nonhybrid operating room, with transesophageal and epicardial echocardiography guidance.Nine amplatzer muscular vsd devices with a mean size of 10 (4-14) mm were deployed.There was a periprocedural complication with one patient with a single apical ventricular septal defect (vsd).During the periventricular procedure, deployment of the left part of the device resulted in the puncture of the posterior wall of the left ventricle.Cardiac pulmonary bypass (cpb) was instituted with a single atrial cannula and stable perfusion was quickly established.Hemostatic repair of the left ventricle was accomplished with a single epicardial stitch, and device closure of the vsd was thereafter successfully completed with cpb support without cardioplegic arrest.

Manufacturer Narrative

An event of a puncture of the posterior wall during deployment was reported.A more comprehensive assessment could not be performed since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.

• Brand Name: AMPLATZER MUSCULAR VSD OCCLUDER
• Type of Device: TRANSCATHETER SEPTAL OCCLUDER
• Manufacturer (Section D): AGA MEDICAL CORPORATION; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 10049703
• MDR Text Key: 190908490
• Report Number: 2135147-2020-00193
• Device Sequence Number: 1
• Product Code: MLV
• Combination Product (y/n): N
• PMA/PMN Number: P040040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Type of Report: Initial,Followup
• Report Date: 06/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 9-VSD-MUSC-010
• Device Catalogue Number: 9-VSD-MUSC-010
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Other; Required Intervention
• Patient Age: 3 MO
• Patient Weight: 3