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

Model Number	9-ASD-036
Medical Device Problem Code	Difficult to Fold, Unfold or Collapse (1254)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/06/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on 06 april 2023, a 36 mm amplatzer septal occluder was chosen for implantation into an atrial septal defect (asd) utilizing an 12f amplatzer trevisio intravascular delivery system.The asd was measured to be slightly greater than 32 mm.During deployment, the left disc of the device inverted and became conical while attempting to recapture.There was no interaction with cardiac structures during deployment.It took a few attempts to get the occluder back into the delivery system.The device was deployed and recaptured multiple times during the procedure but still exhibited the same deformation.The device was removed from the patient, deployed outside of the patient on the back table, and then re-inserted into the patient, but the same deformation was still observed.The device was replaced with a 38 mm amplatzer septal occluder, but the device was determined to be too large for the defect.There was no angulation or kink in the delivery system.No device was implanted.There was a significant delay in procedure, but the patient was not hemodynamically compromised.There were no reported adverse patient effects.The patient was reported as stable.
Additional Manufacturer Narrative
Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Additional Manufacturer Narrative
An event of device deformity could not be confirmed.The device was returned to abbott for investigation and the device met functional specifications when analyzed under non-physiological conditions.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all defined manufacturing specifications.Information from field indicated that there was no angulation or kink in the delivery system was noted, there was no interaction with cardiac structures during deployment, and an 12f delivery sheath was used.Based on the information reviewed and returned device analysis, the cause of the reported incident could not be conclusively determined.There is no indication of a product quality issue with regards to manufacture, design, or labeling.

• Brand Name: AMPLATZER SEPTAL OCCLUDER
• Common Device Name: TRANSCATHETER SEPTAL OCCLUDER
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane n; plymouth MN 55442
• Manufacturer (Section G): ST. JUDE MEDICAL #3014918977; edificio #44 calle 0, ave. 2; el coyol alajuela 1897- 4050; CS 1897-4050
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 16845000
• Report Number: 2135147-2023-01887
• Device Sequence Number: 12480131
• Product Code: MLV
• UDI-Device Identifier: 00811806010250
• UDI-Public: 00811806010250
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P000039
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/30/2023

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: 02/28/2025
• Device Model Number: 9-ASD-036
• Device Catalogue Number: 9-ASD-036
• Device Lot Number: 7443789
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/06/2023
• Supplement Date Received by Manufacturer: 05/21/2023
• Initial Report FDA Received Date: 05/01/2023
• Supplement Report FDA Received Date: 05/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/17/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: AMPLATZER TREVISIO INTRAVASCULAR DELIVERY SYSTEM,
• Patient Sex: Female