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

Catalog Number	9-ASD-015
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	10/18/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on 18 october 2023, a 15mm amplatzer septal occluder was chosen for a 14mm atrial septal defect (asd) closure procedure using a 7f amplatzer trevisio intravascular delivery system.During the procedure, the device would not fit through the hub of the delivery system.The device was then removed from the patient table and checked over on the back table.Upon re-prepping, the device then deformed while being pulled into the 7fr loader.The first 15mm aso never went in the body.There was no report of any interaction with cardiac structures during deployment and no report of any angulation/kink noticed with the delivery system.A new 15mm amplatzer septal occluder and 8f amplatzer trevisio intravascular delivery system were chosen.When the second 15mm amplatzer septal occluder was advanced through the sheath to the left atrium, after a few attempted deployments in difficult anatomy, the device deformed into a cobra head in the body.The device was removed successfully through the sheath, and was never released from the cable.A new third 15mm amplatzer septal occluder was chosen.When the third device positioned on the atrial septum and determined to be too small by color flow doppler.The device was removed from the body through the sheath and was never released from the cable.There was no additional product experience other than the mis-sizing.A new 18mm amplatzer septal occluder was chosen prepared and advanced through the 8fr sheath.The device was successfully implanted with no difficulties and complications.The patient remained hemodynamically stable throughout the procedure.The patient was reported 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 during prep was reported.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.The cause of the reported incident 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: 18093723
• Report Number: 2135147-2023-04928
• Device Sequence Number: 6725525
• Product Code: MLV
• UDI-Device Identifier: 00811806010120
• UDI-Public: 00811806010120
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/27/2023

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: 12/31/2024
• Device Catalogue Number: 9-ASD-015
• Device Lot Number: 7356668
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/18/2023
• Supplement Date Received by Manufacturer: 11/10/2023
• Initial Report FDA Received Date: 11/08/2023
• Supplement Report FDA Received Date: 11/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/22/2020
• 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: 4 YR
• Patient Sex: Female
• Patient Weight: 15 KG