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

Model Number	9-ASD-009
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	06/30/2022
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 a 9mm amplatzer septal occluder was selected for an implant on (b)(6) 2022.During the procedure the device came out of the sheath in cobra shape; device was removed from the patient prior to release from the delivery cable.There was no angulation or kink noticed in the delivery system and no interaction with cardiac structures during deployment.A 10mm amplatzer septal occluder was used to finish the procedure.The patient was reported to be in stable condition.
Event or Problem Description
It was reported that a 9mm amplatzer septal occluder was selected for an implant on (b)(6) 2022 using a amplatzer trevisio intravascular delivery system.During the procedure the device came out of the sheath in cobra shape; device was removed from the patient prior to release from the delivery cable.There was no angulation or kink noticed in the delivery system and no interaction with cardiac structures during deployment.A 10mm amplatzer septal occluder was used to finish the procedure.The patient was reported to be in stable condition.
Additional Manufacturer Narrative
An event of device deformity was reported.Two images were received from the field and they appeared to show an occluder being deployed from a loader outside of the patient in a cobra shaped conformation however, the device met functional specifications when analyzed at abbott 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 specifications.The cause of the reported incident could not be conclusively determined, but may be do to deploying the occluder with a larger than indicated delivery system.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.Please note, per the amplatzer septal occluder instructions for use, artmt600034451 revision c, table 1: the recommended size delivery system for a 9mm amplatzer septal occluder is 6f.

• 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: 15018481
• Report Number: 2135147-2022-00505
• Device Sequence Number: 17856845
• Product Code: MLV
• UDI-Device Identifier: 05415067019172
• UDI-Public: 05415067019172
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• 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): 09/26/2022

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: 08/31/2024
• Device Model Number: 9-ASD-009
• Device Catalogue Number: 9-ASD-009
• Device Lot Number: 7199087
• 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: 06/30/2022
• Supplement Date Received by Manufacturer: 08/31/2022
• Initial Report FDA Received Date: 07/14/2022
• Supplement Report FDA Received Date: 09/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/26/2019
• 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 Sex: Unknown