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

Catalog Number	9-ASD-028
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	09/27/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that a 28mm amplatzer septal occluder was selected for implant on (b)(6) 2024 using a 10f amplatzer trevisio intravascular delivery system.During implant both discs of the device took on a cobra shape.Several attempts were made to re-deploy the device, however the device did not conform to its original shape.The device was never released from the delivery cable.The device was removed from the patient and replaced with a new 30mm amplatzer septal occluder.During implant it was determined that the device was too big and did not optimally fit in the interatrial septum.The device was removed from the patient and replaced with a new 26mm amplatzer septal occluder.The device fit well with the patient anatomy and was implanted.There were no interactions with cardiac structures.There were no angulations or kinks noted on the delivery system.The patient remained hemodynamically stable.There were no clinically significant delays in the procedure.There were no adverse effects to the patient.The patient status was stable.
Additional Manufacturer Narrative
An event of device deformity was reported.Also reported that the device was removed from the patient and replaced with a new 26 mm amplatzer septal occluder; the device fit well with the patient anatomy and was implanted.Information from the field indicated there were no interactions with cardiac structures and there were no angulations or kinks noted on the delivery system.The correct size delivery system was used as per instructions for use.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.Images from field appeared to show the occluder device deformed in cobra conformity.It is possible that the device was oversized as a smaller device fit well in the anatomy and was implanted; however, the exact cause of device deformity could not be conclusively determined.There were no complaints associated with any other devices from the lot.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: 20495930
• Report Number: 2135147-2024-05216
• Device Sequence Number: 19885988
• Product Code: MLV
• UDI-Device Identifier: 00811806010212
• UDI-Public: (01)00811806010212(17)280229(10)8938695
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: P000039
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• 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): 11/22/2024

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-028
• Device Lot Number: 8938695
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/27/2024
• Supplement Date Received by Manufacturer: 11/15/2024
• Initial Report FDA Received Date: 10/21/2024
• Supplement Report FDA Received Date: 11/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/13/2023
• 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: 33 YR
• Patient Sex: Male