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

Model Number	9-ASD-030
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	11/04/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on (b)(6) 2022, a 26mm amplatzer septal occluder was chosen for implant.It was determined to be too small.Therefore, the device was sized up to a 30mm amplatzer septal occluder.When it was attempted to implant using an unknown delivery system, the 30mm device deployed in a cobra headed formation.It was unknown if there were any kinks or angulation noticed in the delivery system.It was unknown if the device made contact with cardiac structures during deployment.The deformed device was not released from the delivery cable while inside the body.Then an additional unknown device was chosen for implant.The replacement device was successfully implanted.
Additional Manufacturer Narrative
Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
An event of device deformed into cobra shape could not be confirmed.A returned device assessment could not be performed as the device was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.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.Information from field indicated that it was unknown whether there was interaction with cardiac structures during deployment, or if angulation or kink in the delivery system was noted.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: 15884129
• Report Number: 2135147-2022-02259
• Device Sequence Number: 12040543
• Product Code: MLV
• UDI-Device Identifier: 05415067019332
• UDI-Public: 05415067019332
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: P000039
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• 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): 02/10/2023

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: 03/31/2026
• Device Model Number: 9-ASD-030
• Device Catalogue Number: 9-ASD-030
• Device Lot Number: 7918632
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/04/2022
• Supplement Date Received by Manufacturer: 02/06/2023
• Initial Report FDA Received Date: 11/30/2022
• Supplement Report FDA Received Date: 02/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/07/2021
• 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 Sex: Unknown