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

Catalog Number	9-ASD-026
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	07/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on (b)(6) 2024, a 26 mm amplatzer septal occluder was selected for an implant using a 10f amplatzer trevisio intravascular delivery system.During the procedure, the device gained a cobra shape deformity while getting out from delivery system.Device was removed from the patient prior to released from the delivery cable.The device was return to its normal shape after a few manipulations.The physician tried to use it 2 more times.However, the result was the same couldn't return to its normal shape after manipulations.The patient was refer for surgical atrial septal defect (asd) closure.No interaction with cardiac structures during deployment and no angulation or kink noticed in the delivery system.The patient is stable.
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.Possible causes of device deformity include use of the incorrect size delivery system, anatomical interference, and angulation or kink in the delivery system upon deployment.The correct delivery system was used and no anatomical interference, or angulation or kink in the delivery system was reported.Abbott requested for device/issue images to review; this was not provided by the site.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed, and the product met all defined manufacturing specifications.There were no complaints associated with any other devices from the lot.Based on the information received, the cause of the reported incident could not be conclusively determined.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.

• 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: 19828971
• Report Number: 2135147-2024-03580
• Device Sequence Number: 8159481
• Product Code: MLV
• UDI-Device Identifier: 00811806010205
• UDI-Public: 00811806010205
• Combination Product (Y/N): N
• Initial Reporter Country: IR
• PMA/510(K) Number: P000039
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/25/2024

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-026
• Device Lot Number: 8792753
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/01/2024
• Initial Report FDA Received Date: 07/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/07/2022
• 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
• Patient Age: 10 YR
• Patient Sex: Male
• Patient Weight: 21 KG