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

Model Number	9-PFO-3025
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	Embolism/Embolus (4438)
Date of Event	07/07/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported on 07 july 2026 that a 30-25mm amplatzer talisman pfo occluder was chosen for implant using a 9f amplatzer talisman delivery system.The defect was reported to be large patent formen ovale (pfo) with a width of approximately 8mm and a septum primum aneurysm.Transesophageal echocardiogram (tee) was used during the procedure.A stability check was reported to have been performed, with no leak detected around the device.No difficulty with implantation, including multiple recaptures or repositioning, was reported, and no rhythm change occurred during the procedure.The device was successfully deployed and released.A few minutes after release, the device embolized and migrated to the ascending aorta.A transthoracic echocardiogram (tte) reportedly identified the embolization.No partial or complete obstruction of blood flow was reported, and the patient reportedly experienced no clinical signs or symptoms associated with the event.It was reported that a percutaneous retrieval attempt was unsuccessful and was followed by surgical retrieval via vascular surgery.
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: 50106009
• Report Number: 2135147-2026-05275
• Device Sequence Number: 10033030
• Product Code: MLV
• UDI-Device Identifier: 05415067033321
• UDI-Public: (01)05415067033321(17)280531(10)10894026
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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
• Report Date (Section B): 07/31/2026

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: 10894026
• 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: 07/07/2026
• Initial Report FDA Received Date: 07/31/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/05/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown