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

Model Number	9-ASD-012
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/16/2021
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 12mm amplatzer septal occluder(aso) was selected for implant.However, the aso deformed into a cobra head shape and could not be deployed normally when the physician attempted to deploy the aso in the patient's atrium.The aso was removed from the patient once and the physician attempted to restore the shape by hand, but the aso could not be reshaped from the cobra head shape although several attempts were made.The physician decided it was impossible to restore the shape of the aso.The aso was replaced with another same-sized, same lot aso and the implant procedure was completed successfully with no consequence to the patient.
Additional Manufacturer Narrative
The reported event of the device deforming into a cobra head shape could not be confirmed.A more comprehensive assessment could not be performed as the device 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 SEPTAL OCCLUDER
• Common Device Name: TRANSCATHETER SEPTAL OCCLUDER
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 11348546
• Report Number: 2135147-2021-00068
• Device Sequence Number: 4107160
• Product Code: MLV
• UDI-Device Identifier: 00811806010090
• UDI-Public: 00811806010090
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P000039
• 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,foreig
• Initial Reporter Occupation: Physician
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 03/23/2021

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: 10/31/2024
• Device Model Number: 9-ASD-012
• Device Catalogue Number: 9-ASD-012
• Device Lot Number: 7285197
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/16/2021
• Supplement Date Received by Manufacturer: 03/15/2021
• Initial Report FDA Received Date: 02/19/2021
• Supplement Report FDA Received Date: 03/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 74 YR
• Patient Weight: 50