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

Model Number	9-VSD-MUSC-018
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/14/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The results/method, conclusion codes, along with investigation results will be provided in the final report.
Event or Problem Description
On (b)(6) 2020, an 18mm amplatzer muscular vsd was selected for implant.Upon deployment the right atrial disk did not reform to its original shape and formed a cobra shape.It was removed, and another 18mm vsd device was successfully deployed through the same delivery systems.
Additional Manufacturer Narrative
Additional information for d10, g4, g7, h2, h3, h6, h10.The reported event of device deformation could not be confirmed.The investigation confirmed the device met visual and functional specifications when analyzed at abbott.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.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): AGA MEDICAL CORPORATION; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 10667602
• Report Number: 2135147-2020-00431
• Device Sequence Number: 19801178
• Product Code: MLV
• UDI-Device Identifier: 00811806011851
• UDI-Public: 00811806011851
• Combination Product (Y/N): N
• Initial Reporter State: MT
• Initial Reporter Country: US
• PMA/510(K) Number: P040040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 10/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2025
• Device Model Number: 9-VSD-MUSC-018
• Device Catalogue Number: 9-VSD-MUSC-018
• Device Lot Number: 7477426
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/05/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/14/2020
• Supplement Date Received by Manufacturer: 10/13/2020
• Initial Report FDA Received Date: 10/12/2020
• Supplement Report FDA Received Date: 10/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 80 YR
• Patient Weight: 71