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

Model Number	9-ASD-006
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2021
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
It was reported that on (b)(6) 2021, a 6 mm amplatzer septal occluder was selected for implant.During the implant procedure, while deploying the device, the distal desk presented in a cobra deformation.Attempts to return the device to it's normal shaped were unsuccessful.The device was replaced with a new 6 mm amplatzer septal occluder and successfully implanted to resolve the event.There was no clinically significant delay in the procedure and the patient remained hemodynamically stable throughout.The patient is currently stable with no adverse events.No additional information was provided.
Additional Manufacturer Narrative
The reported event of the distal disk deploying with a cobra deformation 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: 12253358
• Report Number: 2135147-2021-00305
• Device Sequence Number: 11973822
• Product Code: MLV
• UDI-Device Identifier: 00811806010038
• UDI-Public: 00811806010038
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 08/06/2021

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: 09/30/2024
• Device Model Number: 9-ASD-006
• Device Catalogue Number: 9-ASD-006
• Device Lot Number: 7254064
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/01/2021
• Supplement Date Received by Manufacturer: 07/30/2021
• Initial Report FDA Received Date: 07/30/2021
• Supplement Report FDA Received Date: 08/06/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1