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

Model Number	9-PFO-3025
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	03/23/2026
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 on (b)(6) 2026, a 30-25mm amplatzer talisman pfo occluder was chosen for a procedure.On initial preparation, the tuohy would not tighten around the delivery system and kept leaking.The tuohy replaced with the other on the come with the trevisio and it worked/sealed.They completed the preparation of the 30 talisman and then attempted to introduced it into the trevisio sheath.The device would not pass through the hub, took the device out repressed, and reattempted to introduce into the sheath.But still would not pass through the hub of the treviso sheath hub.The treviso sheath was replaced with a new 9f trevisio and inserted the device it into the sheath without difficulty.The device got deployed the left atrial (la) disc, but when trying to deploy the right atrial (ra) disc the device pulled across the septum into the ra.They took the device out and re-prepped it.They re-inserted and deployed without difficulty.Upon disc deployment, both the ra and oa disc were bulbous in appearance.The device was replaced with a new 30mm talisman.The deformed device was never released from the delivery cable while inside the patient.There was no report of any interaction with cardiac structures during deployment and no report of any angulation/kink noticed with the delivery system.The new device got prepped and deployed without issue and patent foramen ovale (pfo) was successfully closed.The device was successfully detached from delivery catheter and patient was successfully closed.The patient remained hemodynamically stable throughout the procedure.There was some delay in the procedure, the delay was only related to the removal of the device followed by the prep, insertion, and deployment of the second device.The patient was reported discharged.

• Brand Name: AMPLATZER TALISMAN PFO OCCLUDER
• 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: 24911125
• Report Number: 2135147-2026-02479
• Device Sequence Number: 18591844
• Product Code: MLV
• UDI-Device Identifier: 05415067033321
• UDI-Public: (01)05415067033321(17)270831(10)10531977
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: P120021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/04/2026

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-PFO-3025
• Device Catalogue Number: 9-PFO-3025
• Device Lot Number: 10531977
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/07/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/23/2026
• Supplement Date Received by Manufacturer: 04/26/2026
• Initial Report FDA Received Date: 04/17/2026
• Supplement Report FDA Received Date: 05/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/24/2024
• 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 Age: 37 YR
• Patient Sex: Female