MAUDE Adverse Event Report: Abbott Medical Amplatzer Talisman PFO Occluder; Transcatheter Septal Occluder

Model Number	9-PFO-3025
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Thrombosis/Thrombus (4440)
Date of Event	08/21/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on (b)(6) 2026, a 30-25mm amplatzer talisman pfo occluder was chosen for implant.During the procedure, heparin was administered and the patient's activated clotting time (act) was reported to be just below 250 seconds.Intracardiac echocardiography (ice) was used for imaging guidance.Prior to device release, an acute, soft thrombus was observed on the distal cable.The thrombus was captured and pulled back with the device, and the device was subsequently removed.At the time of the procedure, no known hematologic disorder or systemic illness contributing to hypercoagulability had been identified, although a hematology workup was initiated.The procedure was aborted to allow for further hematologic evaluation.The patient remained stable and was subsequently discharged.
Additional Manufacturer Narrative
The device is not returning for evaluation.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

• 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 ; +1(651)756-5400
• MDR Report Key: 50801575
• Report Number: 2135147-2026-06269
• Device Sequence Number: 8652967
• Product Code: MLV
• UDI-Device Identifier: 05415067033321
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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
• Report Date (Section B): 09/17/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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: 11342064
• 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: 08/21/2026
• Initial Report FDA Received Date: 09/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/07/2026
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Sex: Unknown