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

Catalog Number	9-ASD-017
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	07/30/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is expected to be returned for evaluation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that on (b)(6) 2024, a 17mm amplatzer septal occluder was chosen for a atrial septal defect (asd) closure using a 8f amplatzer trevisio intravascular delivery system.The defect size was 13mm x 7mm on 3d transesophageal echocardiography (tee) and 16mm with sizing balloon under fluoroscopy and 18mm with sizing balloon under tee.The device was prepared according to the instructions of the use (ifu) but during deployment the left disc showed a cobra head deformity.The device was recaptured and deployed again but still had the cobra head shape.The device was then retrieved and physician deployed the device on table but couldn't reproduce the cobra head shape, the device looked normal but the two discs were flat.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 and no report of any angulation/kink noticed with the delivery system.A new 17mm amplatzer septal occluder was chosen and successfully deployed.The patient remained hemodynamically stable throughout the procedure.There was no clinically significant delay in procedure and no adverse patient effects.The patient was reported discharged.
Additional Manufacturer Narrative
An event of device deformation was reported.The device was returned to abbott for investigation and the device met functional specifications when analyzed under non-physiological conditions.Use of the incorrect size delivery system, anatomical interference, and angulation or kink in the delivery system upon deployment are potential causes of the reported event.It was indicated that an 8f delivery system was used to deploy the device which may have contributed to the reported event.The recommended size delivery system for use with a 17 mm amplatzer septal occluder is an 70f.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed, and the product met all specifications.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: 20046984
• Report Number: 2135147-2024-04110
• Device Sequence Number: 15464723
• Product Code: MLV
• UDI-Device Identifier: 00811806010144
• UDI-Public: (01)00811806010144(17)280430(10)9075607
• 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: 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): 09/24/2024

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-017
• Device Lot Number: 9075607
• 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: 07/30/2024
• Supplement Date Received by Manufacturer: 09/09/2024
• Initial Report FDA Received Date: 08/23/2024
• Supplement Report FDA Received Date: 09/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/01/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 8F AMPLATZER TREVISIO INTRAVASCULAR DELIVERY SYSTE
• Patient Sex: Female