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

Model Number	9-VSD-MUSC-016
Medical Device Problem Code	Human-Device Interface Problem (2949)
Health Effect - Clinical Code	Hemolysis (1886)
Date of Event	03/11/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.
Event or Problem 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.
Additional 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
• Common Device Name: TRANSCATHETER SEPTAL OCCLUDER
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 11924230
• Report Number: 2135147-2021-00198
• Device Sequence Number: 10974702
• Product Code: MLV
• UDI-Device Identifier: 00811806011844
• UDI-Public: 00811806011844
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P040040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/17/2021

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
• Operator of Device: 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
• Initial Date Received by Manufacturer: 05/05/2021
• Supplement Date Received by Manufacturer: 06/09/2021
• Initial Report FDA Received Date: 06/02/2021
• Supplement Report FDA Received Date: 06/17/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention