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

Model Number	9-ASD-008
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	03/29/2023
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 (b)(6) 2023, an 8mm amplatzer septal occluder was chosen for atrial septal defect implant post mitraclip procedure with a 10f amplatzer torqvue delivery system.During deployment, it was noticed the occluder had a cobra deformation and a decision was made to replace the device with a 9mm amplatzer septal occluder.The replacement 9mm occluder was implanted in the patient with no adverse patient consequences.It was reported there was no angulation/kink noticed with the delivery system, the deformed device was never released from the delivery cable while inside the patient, and there was no interaction with any cardiac structures during deployment.There was no clinically significant delay in the procedure due to the event.The patient remained hemodynamically stable throughout the procedure and their status was reported as stable.
Additional Manufacturer Narrative
An event of device deformity could not be confirmed.The device was returned to abbott for investigation and the device met functional specifications when analyzed under non-physiological conditions.Additionally, a photo was received from the field and a photo appeared to show the device deformity.However, it could not be confirmed as there was no shape of device deformity during the returned device analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all defined manufacturing specifications.Per the instructions for use, the minimum recommended the sheath size delivery system for use with a 8 mm amplatzer septal occluder is an 6f.It was reported that a 10f delivery sheath was used to deliver the device which contributed to the device deformity; noted, the use of a larger sheath may influence deformations of the device.A letter to address the deviation from the instructions for use will not be requested, per case detail, the nurse pulled delivery system off from the shelf.

• 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 ; CS
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 16809939
• Report Number: 2135147-2023-01816
• Device Sequence Number: 3063488
• Product Code: MLV
• UDI-Device Identifier: 05415067019165
• UDI-Public: 05415067019165
• 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: 2023
• Device Explanted Year: 2023
• 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): 05/23/2023

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: 07/31/2025
• Device Model Number: 9-ASD-008
• Device Catalogue Number: 9-ASD-008
• Device Lot Number: 7645504
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/14/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/29/2023
• Supplement Date Received by Manufacturer: 05/16/2023
• Initial Report FDA Received Date: 04/25/2023
• Supplement Report FDA Received Date: 05/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/01/2020
• 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
• Concomitant Medical Products and Therapy/Usage Dates: AMPLATZER TORQVUE DELIVERY SYSTEM, 9-ITV10F45/80.
• Patient Sex: Unknown