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

Model Number	9-ASD-MF-035
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/09/2020
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) 2020, a 35 mm amplatzer cribriform occluder was selected for implant.While deploying, the device wouldn't return to its normal shape.The occluder was recaptured and removed to resolve the event.There was no clinically significant delay in the procedure and the patient remained hemodynamically stable throughout.The patient is stable with no consequences.
Additional Manufacturer Narrative
The reported event of the device not returning to its normal shape during deployment was confirmed.Following the simulated deployment, the bulbous shape returned to normal and met 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 defined manufacturing specifications.A capa was initiated for further investigation and did not identify a product quality issue.However, corrective actions to further enhance performance are being pursued per internal operating procedures.

• Brand Name: AMPLATZER CRIBRIFORM OCCLUDER
• Common Device Name: TRANSCATHETER SEPTAL OCCLUDER
• Manufacturer (Section D): AGA MEDICAL CORPORATION; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 11120209
• Report Number: 2135147-2020-00565
• Device Sequence Number: 3595619
• Product Code: MLV
• UDI-Device Identifier: 00811806010311
• UDI-Public: 00811806010311
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P000039
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• 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): 01/25/2021

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: 02/28/2021
• Device Model Number: 9-ASD-MF-035
• Device Catalogue Number: 9-ASD-MF-035
• Device Lot Number: 5413981
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/09/2020
• Supplement Date Received by Manufacturer: 01/17/2021
• Initial Report FDA Received Date: 01/05/2021
• Supplement Report FDA Received Date: 01/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1