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

Model Number 9-VSD-MUSC-016

Device Problem Human-Device Interface Problem (2949)

Patient Problem Hemolysis (1886)

Event Date 03/11/2021

Event Type  Injury  

Manufacturer Narrative

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

Event Description

On (b)(6) 2021, a 16mm amplatzer vsd occluder was implanted in a patient with a past medical history of coronary artery disease (cad), rv enlargement, pulmonary hypertension, and cardiogenic shock.Post-implant, it was reported that residual shunt was observed.On (b)(6) 2021, the patient hemolyzed and was treated with hemodialysis and supportive care.No malfunction was reported with the occluder.The patient was reported to be in stable condition.This event will be conservatively reported.

Manufacturer Narrative

An event of residual shunt and hemolysis was reported.A more comprehensive assessment could not be performed as the device remains implanted 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.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): ABBOTT MEDICAL; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 11924230
• MDR Text Key: 254051165
• Report Number: 2135147-2021-00198
• Device Sequence Number: 1
• Product Code: MLV
• UDI-Device Identifier: 00811806011844
• UDI-Public: 00811806011844
• Combination Product (y/n): N
• PMA/PMN Number: P040040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 06/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/29/2024
• Device Model Number: 9-VSD-MUSC-016
• Device Catalogue Number: 9-VSD-MUSC-016
• Device Lot Number: 6903058
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention