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

Model Number	9-ASD-022
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	04/05/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on (b)(6) 2023, a 24mm amplatzer septal occluder (lot 8406508) was chosen for implantation into an atrial septal defect (asd) utilizing a 9f amplatzer trevisio intravascular delivery system (lot 8234812).During implantation, a cobra shaped deformation was observed in the occluder.The device was retracted, realigned, and flushed before re-trying implantation, but the cobra deformation occurred again.The device was removed and a replacement 22mm amplatzer septal occluder (lot 8393118) was attempted to be implanted utilizing a new 9f amplatzer trevisio intravascular delivery system (lot 8337467).During implantation, this device also had a cobra shaped deformation.Implantation was reattempted, but the issue persisted.A third 18mm amplatzer septal occluder (lot 8293150) was then successfully implanted utilizing a third 9f amplatzer trevisio intravascular delivery system (lot 8337467).The patient remained hemodynamically stable throughout the procedure.There was no interaction with any cardiac structures during the deployment of the first two devices.No angulation or kinking was noted in any of the delivery systems.There was no clinically significant delay and no adverse patient effects.The patient status was reported as 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 was reported.A returned device inspection could not be performed as the device was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.There were no complaints associated with any other devices from the lot.Information from the field indicated that there was no anatomical interference or any angulation or kink in the delivery system upon deployment and a 9f delivery sheath was used.The cause of the reported incident could not be conclusively determined.There is no indication for a product quality issue with regards to manufacture, design, or labeling.

• 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: 16811789
• Report Number: 2135147-2023-01827
• Device Sequence Number: 11493032
• Product Code: MLV
• UDI-Device Identifier: 05415067019295
• UDI-Public: 05415067019295
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 05/09/2023

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 Model Number: 9-ASD-022
• Device Catalogue Number: 9-ASD-022
• Device Lot Number: 8393118
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/05/2023
• Supplement Date Received by Manufacturer: 04/30/2023
• Initial Report FDA Received Date: 04/25/2023
• Supplement Report FDA Received Date: 05/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/21/2022
• 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 TREVISIO INTRAVASCULAR DS, 9-ATV09F45/80; AMPLATZER TREVISIO INTRAVASCULAR DS, 9-ATV09F45/80
• Patient Sex: Male