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 Known Impact Or Consequence To Patient (2692)
Date of Event	01/17/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2019, a 18mm amplatzer muscular vsd occluder was selected for use.During device deployment, one of the discs deployed in an oval shape.The device was re-deployed a second time but the issue remained.The device was retrieved, exchanged for a 16 vsd occluder and successfully implanted.There were no patient consequences.
Additional Manufacturer Narrative
The reported event of deformity upon deployment was confirmed.The investigation confirmed the distal disc of the device deployed in an oval shape when analyzed at abbott under non-physiological conditions.Bent wires were seen on the distal disc, which potentially contributed to the deformation.As this was a used device, the cause of the wire damage could not be conclusively determined.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.The cause of the reported event 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: 8376584
• Report Number: 2135147-2019-00056
• Device Sequence Number: 19321311
• Product Code: MLV
• UDI-Device Identifier: 00811806011851
• UDI-Public: 00811806011851
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• PMA/510(K) Number: P040040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/15/2019

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: 04/30/2022
• Device Model Number: 9-VSD-MUSC-018
• Device Lot Number: 5993647
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/04/2019
• Supplement Date Received by Manufacturer: 04/09/2019
• Initial Report FDA Received Date: 02/27/2019
• Supplement Report FDA Received Date: 04/15/2019
• 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