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

Model Number	9-PFO-1818
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	03/17/2026
Type of Reportable Event	Malfunction
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.
Event or Problem Description
It was reported that on 17 mar 2026, a 18-18mm amplatzer talisman pfo occluder was chosen for implant using a 9f talisman delivery system.During the procedure, while the device was expanding inside the body, it was observed the right atrium disc of the occluder conformed into a bulbous deformation.The deformed device was never released from the delivery cable.There was interaction with the cardiac structures during deployment and no angulation/kink were noticed in the delivery system.The procedure was completed using a 25-18mm amplatzer pfo occluder.The patient remained hemodynamically stable throughout the procedure.There was no clinically significant delay in procedure and no adverse patient effects.

• 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: 24845897
• Report Number: 2135147-2026-02332
• Device Sequence Number: 5663672
• Product Code: MLV
• UDI-Device Identifier: 05415067033307
• UDI-Public: (01)05415067033307(17)270228(10)10252206
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/19/2026

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-1818
• Device Catalogue Number: 9-PFO-1818
• Device Lot Number: 10252206
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/17/2026
• Supplement Date Received by Manufacturer: 05/09/2026
• Initial Report FDA Received Date: 04/11/2026
• Supplement Report FDA Received Date: 05/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/15/2024
• 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: 59 YR
• Patient Sex: Male