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

Model Number	9-PFO-2518
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/18/2025
Type of Reportable Event	Serious Injury
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 (b)(6) 2025, a 25¿18 mm amplatzer patent foramen ovale (pfo) occluder was implanted in the patient.The sizing of the device was determined using transesophageal echocardiography (toe).During the procedure, fluoroscopy was used as the imaging modality.On (b)(6) 2025, the patient returned for a follow-up visit four weeks after the implantation.During the check-up, a transesophageal echocardiography (toe) imaging study identified that the occluder had embolized to the descending aorta.The clinic decided to attempt retrieval of the occluder via an interventional snaring procedure.After several hours, the device could not be removed.The localization was then changed from the descending aorta to the internal iliac artery, where a vascular surgeon was able to explant the device.The patient was reported to be stable and admitted to the intensive care unit (icu).The implanter believes the cause of embolization was misjudgment of the anatomy.A stability check was performed during implantation, and the wiggle manoeuvre was used.There was no difficulty during implantation, and no multiple recaptures or repositioning were required.The patient exhibited no clinical signs or symptoms during or after the event and left the hospital without any symptoms after implantation.The embolized occluder did not cause any significant blockage of blood flow or consequences for the patient.The retrieval of the embolized device was considered an emergency procedure to prevent serious consequences, including permanent impairment or death.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
An event of device embolization was reported.A returned device assessment could not be performed as the device was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed, and the product met all defined manufacturing specifications.Additionally, the lot was reviewed for similar complaints, and there is no indication of a lot-specific product issue.Based on the available information, the cause for the reported device embolization is likely related to misjudgment of the anatomy, however this could not be determined.An unexpected medical intervention was a result of case specific circumstances, as the device was removed via snare.There is no indication of a product quality issue with respect to labeling, design, or manufacturing of the device.

• 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: 23772002
• Report Number: 2135147-2025-07276
• Device Sequence Number: 9657044
• Product Code: MLV
• UDI-Device Identifier: 05415067033314
• UDI-Public: (01)05415067033314(17)280531(10)10928196
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P120021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• 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): 03/26/2026

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?: No
• Operator of Device: Health Professional
• Device Model Number: 9-PFO-2518
• Device Catalogue Number: 9-PFO-2518
• Device Lot Number: 10928196
• 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: 11/18/2025
• Supplement Date Received by Manufacturer: 03/13/2026
• Initial Report FDA Received Date: 12/10/2025
• Supplement Report FDA Received Date: 03/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/26/2025
• 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: Hospitalization; Required Intervention
• Patient Sex: Unknown