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	Angina (1710)
Date of Event	01/29/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device remains in patient.The device will not be returned 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 30-25mm amplatzer talisman pfo occluder was chosen for implant using 9f amplatzer talisman delivery system.The tunnel dimension was reported as 11 mm.The sizing of the device was determined using transesophageal echocardiography (toe), and toe along with fluoroscopy were used as the imaging modalities during the procedure.The 30¿25 mm amplatzer talisman pfo occluder was implanted, and the toe images were reviewed by the physician.The device appeared stable during the tug test, and no leak was observed around the lobe of the device.There was no difficulty with the implantation, including no multiple recaptures or repositioning, and no rhythm change occurred during the procedure.During a routine transthoracic echocardiogram (tte) performed the following morning, the device was found to have embolized, and this finding was also identified on ct imaging.It was reported that the device had completely dislodged from the implant site and had migrated to the distal aorta at the level of the coeliac artery, where it was positioned vertically.The embolized device did not cause partial or complete obstruction of blood flow.The implanter believes the embolization was likely related to a choking /coughing episode that occurred three days post-implant after the patient ate a cooked sausage.The patient had no clinical signs or symptoms during or immediately after the original event, but following the coughing episode, the patient experienced sudden onset chest pain.On (b)(6) 2026, a percutaneous retrieval procedure was performed to address the embolized device.
Additional Manufacturer Narrative
An event of a device embolization and angina 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 and cine review, the cause for the reported device embolization 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.
Event or Problem Description
It was reported that on (b)(6) 2026, a 30-25mm amplatzer talisman pfo occluder was chosen for implant using 9f amplatzer talisman delivery system.The tunnel dimension was reported as 11 mm.The sizing of the device was determined using transesophageal echocardiography (toe), and toe along with fluoroscopy were used as the imaging modalities during the procedure.The 30¿25 mm amplatzer talisman pfo occluder was implanted, and the toe images were reviewed by the physician.The device appeared stable during the tug test, and no leak was observed around the lobe of the device.There was no difficulty with the implantation, including no multiple recaptures or repositioning, and no rhythm change occurred during the procedure.During a routine transthoracic echocardiogram (tte) performed the following morning, the device was found to have embolized, and this finding was also identified on ct imaging.It was reported that the device had completely dislodged from the implant site and had migrated to the distal aorta at the level of the coeliac artery, where it was positioned vertically.The embolized device did not cause partial or complete obstruction of blood flow.The implanter believes the embolization was likely related to a choking /coughing episode that occurred three days post-implant after the patient ate a cooked sausage.The patient had no clinical signs or symptoms during or immediately after the original event, but following the coughing episode, the patient experienced sudden onset chest pain.On (b)(6) 2026, a percutaneous retrieval procedure was performed to address the embolized 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: 24475443
• Report Number: 2135147-2026-01270
• Device Sequence Number: 9615503
• Product Code: MLV
• UDI-Device Identifier: 05415067033321
• UDI-Public: (01)05415067033321(17)270831(10)10503943
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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,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-3025
• Device Catalogue Number: 9-PFO-3025
• Device Lot Number: 10503943
• 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: 02/03/2026
• Supplement Date Received by Manufacturer: 03/12/2026
• Initial Report FDA Received Date: 02/27/2026
• Supplement Report FDA Received Date: 03/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/05/2024
• 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: 37 YR
• Patient Sex: Male
• Patient Weight: 100 KG