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	12/12/2023
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.Na.
Event or Problem Description
It was reported that a 25mm amplatzer multi-fenestrated septal occluder - cribriform was chosen for implant on (b)(6) 2023 using an 8f amplatzer trevisio intravascular delivery system.During implant it was observed that the device was the incorrect size.The device was replaced with a new 12mm amplatzer septal occluder.The device was observed be a mis-sizing as well.The device was removed from the patient and replaced with a new 15mm amplatzer septal occluder was selected.During implant, the left disc of the device took on a cobra shape.An attempt was made to re-insert the device into the sheath and deploy.The device took on a cobra shape again.The device was removed from the patient and replaced with a new 17mm amplatzer septal occluder.The patient remained hemodynamically stable throughout the procedure.There were no clinically significant delays in the procedures.There were no adverse effects to the patient.
Event or Problem Description
It was reported that a 25mm amplatzer multi-fenestrated septal cribriform occluder was chosen for implant on (b)(6) 2023 using an 8f amplatzer trevisio intravascular delivery system.During implant it was observed that the device was the incorrect size.The device was replaced with a new 12mm amplatzer septal occluder.The device was observed be a mis-sizing as well.The device was removed from the patient and replaced with a new 15mm amplatzer septal occluder was selected.During implant, the left disc of the device took on a cobra shape.An attempt was made to re-insert the device into the sheath and deploy.The device took on a cobra shape again.The device was removed from the patient and replaced with a new 17mm amplatzer septal occluder.The patient remained hemodynamically stable throughout the procedure.There were no clinically significant delays in the procedures.There were no adverse effects to the patient.
Additional Manufacturer Narrative
An event of device deformity could not be confirmed.The device was returned to abbott for investigation and the occluder was measured at 25.98mm on the distal disc and 22.07mm on the proximal disc.The multi-fenestrated occluder was measured to be 24.90mm and 25.01mm.The device for what the complaint is coded for was not returned precluded for functional testing.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all defined manufacturing specifications.Reportedly, one attempt was made to re-insert the device into the sheath and deploy.The cause of reported event 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: 18499416
• Report Number: 2135147-2024-00216
• Device Sequence Number: 18179260
• Product Code: MLV
• UDI-Device Identifier: 00811806010120
• UDI-Public: (01)00811806010120(17)270731(10)8595158
• Combination Product (Y/N): N
• Initial Reporter Country: IS
• 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): 05/09/2024

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-015
• Device Lot Number: 8595158
• 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: 12/20/2023
• Supplement Date Received by Manufacturer: 05/03/2024
• Initial Report FDA Received Date: 01/11/2024
• Supplement Report FDA Received Date: 05/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/02/2022
• 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: 9F AMPLATZER TREVISIO DS 9-ATV08F45/80 LOT: 8242377.
• Patient Sex: Unknown