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

Model Number	9-ASD-MF-030
Medical Device Problem Codes	Difficult to Fold, Unfold or Collapse (1254); Off-Label Use (1494)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/03/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on (b)(6) 2026, a 30mm amplatzer multi-fenestrated septal occluder - cribriform was chosen for a patent foramen ovale (pfo) closure procedure using a 9f amplatzer trevisio intravascular delivery system.During deployment, a heavy bulging on the left atrial disc was noted.The deformed device ever released from the delivery cable while inside the patient.There was report of interaction with cardiac structures was noted during deployment.There was no report of any angulation/kink noticed with the delivery system.A new 30mm amplatzer multi-fenestrated septal occluder - cribriform was chosen and completed the procedure.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
The device is expected to be returned for investigation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.
Additional Manufacturer Narrative
An event of device deformity and off-label use was reported.An image was received from the field of the device in a bulbous like deformation.The device was returned to abbott for investigation and the device met functional specifications when analyzed 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.There were no complaints associated with any other devices from the lot.The cause of the reported device deformity could not be conclusively determined.The reported off-label use is related to the cribriform device being used to treat a patent foramen ovale.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.
Event or Problem Description
It was reported that on (b)(6) 2026, a 30mm amplatzer multi-fenestrated septal occluder - cribriform was chosen for a patent foramen ovale (pfo) closure procedure using a 9f amplatzer trevisio intravascular delivery system.During deployment, a heavy bulging on the left atrial disc was noted.The deformed device ever released from the delivery cable while inside the patient.There was report of interaction with cardiac structures was noted during deployment.There was no report of any angulation/kink noticed with the delivery system.A new 30mm amplatzer multi-fenestrated septal occluder - cribriform was chosen and completed the procedure.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.

• Brand Name: AMPLATZER MULTI-FENESTRATED SEPTAL OCCLUDER - CRIBRIFORM
• Common Device Name: TRANSCATHETER SEPTAL OCCLUDER
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane n; plymouth MN 55442
• Manufacturer (Section G): ABBOTT MEDICAL REG# 2135147; 5050 nathan ln n; plymouth MN 55442
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 24469548
• Report Number: 2135147-2026-01199
• Device Sequence Number: 18552811
• Product Code: MLV
• UDI-Device Identifier: 00811806010304
• UDI-Public: (01)00811806010304(17)300731(10)10995177
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: P000039
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 03/24/2026

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-030
• Device Catalogue Number: 9-ASD-MF-030
• Device Lot Number: 10995177
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/03/2026
• Supplement Date Received by Manufacturer: 03/14/2026
• Initial Report FDA Received Date: 02/27/2026
• Supplement Report FDA Received Date: 03/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/12/2025
• 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