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

Model Number	9-VSDMPIHDE-024
Medical Device Problem Codes	Improper or Incorrect Procedure or Method (2017); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/12/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The results/method and conclusion codes along with investigation results will be provided in the final report.
Event or Problem Description
On (b)(6) 2021, a 24mm amplatzer post-infarct muscular vsd occluder was selected for implant.During the procedure the device was deformed after placing the device into the post mi defect.The physician deployed, recaptured and repositioned the device twice, but still did not like the position.The physician retracted the device, cleaned it and reloaded the device into the delivery system, but the device was not salvageable.The ventricular disc was cobra shaped and the waist was mangled to the point where the device could not go back to its original shape.The device was exchanged for a 22mm amplatzer post-infarct muscular vsd occluder and successfully implanted without incident.The patient remained hemodynamically stable throughout the procedure and there was no clinically significant delay in the procedure.
Additional Manufacturer Narrative
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.Please note, per the amplatzer post-infarct muscular ventricular septal defect occluder instructions for use, arten600038248 revision b "warnings: do not release the amplatzer¿ post-infarct muscular vsd occluder from the delivery cable if the device does not conform to its original configuration or if the device position is unstable.Recapture the device and redeploy.If still unsatisfactory, recapture the device and replace it with a new device.".

• Brand Name: AMPLATZER
• Common Device Name: TRANSCATHETER SEPTAL OCCLUDER
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 11305171
• Report Number: 2135147-2021-00050
• Device Sequence Number: 4830876
• Product Code: MLV
• UDI-Device Identifier: 05415067028143
• UDI-Public: 05415067028143
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: H070005
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 02/28/2021

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-VSDMPIHDE-024
• Device Catalogue Number: 9-VSDMPIHDE-024
• Device Lot Number: 7469383
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/28/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/12/2021
• Supplement Date Received by Manufacturer: 02/10/2021
• Initial Report FDA Received Date: 02/09/2021
• Supplement Report FDA Received Date: 02/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 63 YR