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	01/26/2026
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
It was reported that on (b)(6) 2026, a 25-18mm amplatzer talisman pfo occluder was implanted.The procedure was performed under intracardiac echocardiography (ice) and fluoroscopic guidance.After device deployment and performance of a stability check (confirmed as performed), it was observed through intracardiac echo and fluoroscopy that the occluder had shifted in position within the intended implant site.Specifically, the right superior disk slipped off the pfo limbus and into the pfo tunnel, indicating migration.The implanter believed the cause of the migration was that the 25-18mm device was too small for the pfo.The migrated occluder was subsequently removed from the patient¿s body using a snare without any issue.Throughout this period, no leak was detected around the device, and no rhythm changes or clinical signs or symptoms such as arrhythmia, interaction with a valve, or hemodynamic instability were observed.The device migration was identified based on imaging findings shortly after deployment.There were no difficulties with device implantation, including no need for multiple recaptures or repositioning.The procedure was completed successfully with the implantation of a 30-25mm amplatzer talisman pfo occlude the patient remained hemodynamically stable throughout the procedure.There was no clinically significant delay in procedure and no adverse patient effects.
Additional Manufacturer Narrative
An event of a device migration 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.There were no complaints associated with any other devices from the lot.Based on the available information, the cause for the reported device migration is likely due to mis-sizing, however this cannot be determined.An unexpected medical intervention was a result of case-specific circumstances, as the device was snared.There is no indication of a product quality issue with respect to labeling, design, or manufacturing of the device.
Event or Problem Description
It was reported that on (b)(6) 2026, a 25-18mm amplatzer talisman pfo occluder was implanted.The procedure was performed under intracardiac echocardiography (ice) and fluoroscopic guidance.After device deployment and performance of a stability check (confirmed as performed), it was observed through intracardiac echo and fluoroscopy that the occluder had shifted in position within the intended implant site.Specifically, the right superior disk slipped off the pfo limbus and into the pfo tunnel, indicating migration.The implanter believed the cause of the migration was that the 25-18mm device was too small for the pfo.The migrated occluder was subsequently removed from the patient¿s body using a snare without any issue.Throughout this period, no leak was detected around the device, and no rhythm changes or clinical signs or symptoms such as arrhythmia, interaction with a valve, or hemodynamic instability were observed.The device migration was identified based on imaging findings shortly after deployment.There were no difficulties with device implantation, including no need for multiple recaptures or repositioning.The procedure was completed successfully with the implantation of a 30-25mm amplatzer talisman pfo occlude 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: 24390246
• Report Number: 2135147-2026-01025
• Device Sequence Number: 21455208
• Product Code: MLV
• UDI-Device Identifier: 05415067033314
• UDI-Public: (01)05415067033314(17)280731(10)11018501
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P120021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/17/2026

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?: No
• Operator of Device: Health Professional
• Device Model Number: 9-PFO-2518
• Device Catalogue Number: 9-PFO-2518
• Device Lot Number: 11018501
• 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: 01/26/2026
• Supplement Date Received by Manufacturer: 03/11/2026
• Initial Report FDA Received Date: 02/19/2026
• Supplement Report FDA Received Date: 03/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/27/2025
• 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; Hospitalization
• Patient Sex: Female