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

Catalog Number	9-ASD-007
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	11/13/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a 7mm amplatzer septal occluder was selected for implant on (b)(6) 2023 using an 8f amplatzer talisman delivery system.During implant the left disc of the device took on a cobra shape.The device was removed from the patient and replaced with a new 8mm amplatzer septal occluder.During implant, the left disc of the device also took on a cobra shape.The device was removed from the patient and replaced with a new 9mm amplatzer septal occluder, which was implanted successfully.There were no interactions with cardiac structures, nor were there any angulations nor kinks noted in the delivery system.The patient remained hemodynamically stable throughout the procedure.There were no adverse effects to the patient.The patient status is noted 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 was reported.A returned device assessment could not be performed as the device was not returned for analysis.However, two photos were received from the field appearing to show the devices presenting deformation.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed, and the product met all defined manufacturing specifications.Based on the information received, the cause of the reported incident could not be conclusively determined but could have been as a result of the use of a larger than recommended delivery system as the use of a larger sheath may influence deformations.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.Please note that the recommended size delivery system per the instructions for use is a 6fna.

• 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: 18277338
• Report Number: 2135147-2023-05343
• Device Sequence Number: 6263759
• Product Code: MLV
• UDI-Device Identifier: 00811806010045
• UDI-Public: 00811806010045
• 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: 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): 01/02/2024

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 Catalogue Number: 9-ASD-007
• Device Lot Number: 8537898
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/13/2023
• Supplement Date Received by Manufacturer: 12/08/2023
• Initial Report FDA Received Date: 12/06/2023
• Supplement Report FDA Received Date: 01/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/24/2022
• 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 TALISMAN DELIVERY SYSTEM, 9-TDS08F45-80
• Patient Sex: Unknown