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

Model Number 9-VSD-MUSC-012

Device Problem Human-Device Interface Problem (2949)

Patient Problem High Blood Pressure/ Hypertension (1908)

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.One patient with holt-oram syndrome was reported to have a significant residual shunt post procedure.The patient remained with residual shunt and pulmonary hypertension and could not be weaned from mechanical ventilatory support and was finally re-operated eight days later.The device was removed and a large, single vsd was successfully implanted.The post-operative course was reported to be uneventful.

Manufacturer Narrative

An event of residual shunt was reported.A more comprehensive assessment could not be performed since the device was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications at the time of commercialization.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: 10049708
• MDR Text Key: 190908264
• Report Number: 2135147-2020-00194
• 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: 05/27/2020

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 Model Number: 9-VSD-MUSC-012
• Device Catalogue Number: 9-VSD-MUSC-012
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/29/2020
• Initial Date FDA Received: 05/12/2020
• Supplement Dates Manufacturer Received: 05/23/2020
• Supplement Dates FDA Received: 05/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Other; Required Intervention
• Patient Age: 7 YR
• Patient Weight: 6