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

Model Number	9-PFO-3525
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	Arrhythmia (1721)
Date of Event	02/06/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device will not be returned for evaluation, the device was reportedly discarded.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 35-25mm amplatzer talisman pfo occluder was chosen for implant using a 9f delivery system in a 61-year-old female patient with a history of stroke and prior surgical aortic valve replacement, who presented to the catheterization lab for pfo closure.During the procedure, the physician attempted to utilize intracardiac echocardiography (ice); however, imaging was limited due to challenging acoustic windows, as the patient¿s heart was noted to be positioned more horizontally.As a result, the physician relied primarily on fluoroscopy for device positioning, with only limited guidance from ice.In this case, given prior aortic valve surgery and the resulting cardiac rotation that limited ice, the physician decided to size based on transesophageal echocardiography (tee).An initial 25-18 mm amplatzer talisman occluder was selected.With only the left disc deployed, a gentle tug was performed to confirm engagement against the septum; the device pulled through, prompting the decision to upsize.35¿25 mm amplatzer talisman occluder was subsequently implanted via a 9f delivery system.A rigorous push¿pull stability test was performed, with no indication of inadequate seating or malposition.The device was placed and the sheath was removed at approximately 9:00 a.M.Immediately following device placement, the patient experienced increased premature ventricular contractions (pvcs), above an already present baseline pvc burden.Based on these findings, the physician performed a point-of-care ultrasound (pocus), which revealed that the occluder had embolized and was located within the tricuspid valve.The device was later successfully retrieved.The implanter believed the cause of embolization was difficult imaging and possible disc placement within the pfo tunnel rather than securely on the septal wall.There was no partial or complete hemodynamic obstruction from the embolized device.The device was percutaneously retrieved via the groin, and the retrieval was considered an emergency to prevent permanent impairment and/or death.The device was successfully retrieved.
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 specifications.There were no complaints associated with any other devices from the lot.Based on the available information, the cause of the reported device embolization could not be conclusively determined.The possible cause could be difficult imaging and possible disc placement within the pfo tunnel rather than securely on the septal wall.However, this cannot be confirmed.The reported arrythmia is caused due to patient's previous health condition and device implantation.The reported unexpected medical intervention was a result of case-specific circumstances as the device was scheduled to be snared.There is no indication of a product quality issue with respect to manufacture, design, or labeling.
Event or Problem Description
N/a.

• 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: 24503141
• Report Number: 2135147-2026-01355
• Device Sequence Number: 16100443
• Product Code: MLV
• UDI-Device Identifier: 05415067033345
• UDI-Public: (01)05415067033345(17)280630(10)10967406
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/19/2026

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?: No
• Operator of Device: Health Professional
• Device Model Number: 9-PFO-3525
• Device Catalogue Number: 9-PFO-3525
• Device Lot Number: 10967406
• 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: 02/06/2026
• Supplement Date Received by Manufacturer: 03/13/2026
• Initial Report FDA Received Date: 03/03/2026
• Supplement Report FDA Received Date: 03/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/24/2025
• 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 Age: 61 YR
• Patient Sex: Female
• Patient Weight: 80 KG