MAUDE Adverse Event Report: ABBOTT MEDICAL AMPLATZER MULTI-FENESTRATED SEPTAL OCCLUDER - CRIBRIFORM; TRANSCATHETER SEPTAL OCCLUDER

Model Number	9-ASD-MF-025
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	03/11/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on (b)(6) 2025, a 25mm amplatzer cribriform occluder was selected for implant using an 8f amplatzer trevisio intravascular delivery system.It was noted during procedure on transesophageal echocardiogram and fluoroscopy, that both lobes of the occluder exhibited a tulip deformation when being deployed.There was no interaction with cardiac structures during deployment.The deformed occluder was never released from the delivery cable while inside the patient.There was no angulation or kink noticed in the delivery system and the occluder was not mishandled or damage at any point during device prep.The decision was made to remove the 25mm amplatzer cribriform occluder and replace it with another one of the same size to complete the procedure.There were no adverse patient effects reported.The patient was fine at the time of report.
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.One image was received from the field showing tulip deformation on both the discs on the operation table.A returned device assessment 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.Additionally, the lot was reviewed for similar complaints, and there is no indication of a lot-specific product issue.Based on available information and without the device to analyze, the cause of the reported event could not be conclusively determined.There is no indication of a product quality issue with respect to manufacture, design, or labeling.

• Brand Name: AMPLATZER MULTI-FENESTRATED SEPTAL OCCLUDER - CRIBRIFORM
• Common Device Name: TRANSCATHETER SEPTAL OCCLUDER
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane north; plymouth MN 55442
• Manufacturer (Section G): ABBOTT MEDICAL REG# 2135147; 5050 nathan ln n; plymouth MN 55442
• Manufacturer Contact: karen krouse ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 21774077
• Report Number: 2135147-2025-01738
• Device Sequence Number: 8220467
• Product Code: MLV
• UDI-Device Identifier: 00811806010298
• UDI-Public: (01)00811806010298(17)270930(10)8703587
• 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: 2025
• Device Explanted Year: 2025
• 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): 05/16/2025

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-MF-025
• Device Catalogue Number: 9-ASD-MF-025
• Device Lot Number: 8703587
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/11/2025
• Supplement Date Received by Manufacturer: 05/06/2025
• Initial Report FDA Received Date: 04/04/2025
• Supplement Report FDA Received Date: 05/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/11/2022
• 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 DS, 9-ATV08F45/80 (LOT: 9004109.
• Patient Sex: Unknown