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

Catalog 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	01/04/2024
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 on 04 january 2024, a 36mm amplatzer septal occluder was chosen for implant using a 12f amplatzer trevisio intravascular delivery system.During procedure, the device had a cobra deformation after full deployment.The left disc opened well, but the right disc could not open and formed a cobra shape.The deformed device was never released from the delivery cable while inside the patient.There was no report of any interaction with cardiac structures during deployment.When the implanter tried to pull in the device and retrieve the sheath, the left disc was not able re-sheath.The implanter used great force to pull device into sheath, with the distal part still partially exposed outside the sheath while removing the whole system.This caused a tear in the femoral vein, but no major bleeding occurred.Upon inspection, the delivery system had crumbled due to the force used to retract the device.A new 34mm amplatzer septal occluder was chosen and successfully implanted.The patient remained hemodynamically stable throughout the procedure.There was no clinically significant delay in procedure.The patient was reported stable.
Additional Manufacturer Narrative
An event of the device deformation was reported.A returned device assessment could not be performed as the device was not returned for analysis.Imaging was received from the field appearing to show the right disc of the device presenting cobra deformation and the distal disc still partially exposed outside the sheath while removing the whole system from the patient.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed, and the product met all specifications.The root cause of the reported event could not be conclusively determined.

• 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: 18596795
• Report Number: 2135147-2024-00397
• Device Sequence Number: 8033837
• Product Code: MLV
• UDI-Device Identifier: 00811806010250
• UDI-Public: 00811806010250
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• 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): 03/05/2024

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 Expiration Date: 09/30/2024
• Device Catalogue Number: 9-ASD-036
• Device Lot Number: 7245345
• 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: 01/04/2024
• Supplement Date Received by Manufacturer: 02/29/2024
• Initial Report FDA Received Date: 01/29/2024
• Supplement Report FDA Received Date: 03/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/28/2019
• 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: 8 YR
• Patient Sex: Female