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

Model Number	9-PFO-2518
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Air Embolism (1697); Non specific EKG/ECG Changes (1817)
Date of Event	10/23/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported on (b)(6) 2025, a 25- 18 mm amplatzer talisman pfo occluder was chosen as an implant using an 8f amplatzer talisman delivery system for a percutaneous transcatheter closure of a patent foramen ovale (pfo).During deployment of the left atrial disc, st segment elevation was observed on electrocardiogram.The changes were attributed to the presence of air affecting the right coronary artery (rca).The patient was treated with medication while waiting for the air to clear.After stabilization and resolution of the air embolism, the pfo closure was completed.
Additional Manufacturer Narrative
The device remains implanted 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.
Additional Manufacturer Narrative
An event with patient effects of ekg/ecg changes and air embolism was reported.A returned device assessment could not be performed as the device remains implanted.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 patient effects of ekg/ecg changes and air embolism could not be determined.A medical intervention was a result of case-specific circumstances.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 on (b)(6) 2025, a 25- 18mm amplatzer talisman pfo occluder was chosen as an implant using a 8f amplatzer talisman delivery system for a percutaneous transcatheter closure of a patent foramen ovale (pfo).During deployment of the left atrial disc, st segment elevation was observed on electrocardiogram.The changes were attributed to the presence of air affecting the right coronary artery (rca).Air was noted in the patient during pfo implant.The physician believes this was due to air in the talisman sheath or talisman pfo occluder system and released when the pfo occluder disc was deployed.No bubbles were observed in the pfo talisman device during preparation, but bubbles were introduced into the patient as the left disc was deployed.No air bubbles were noted in the loader or hemostasis valve of the talisman pfo occluder.The patient was treated with medication while waiting for the air to clear.After stabilization and resolution of the air embolism, the pfo closure was completed.

• 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: 23570381
• Report Number: 2135147-2025-06694
• Device Sequence Number: 10272626
• Product Code: MLV
• UDI-Device Identifier: 05415067033314
• UDI-Public: (01)05415067033314(17)280630(10)10947037
• 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: 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): 01/14/2026

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: 10947037
• 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: 10/23/2025
• Supplement Date Received by Manufacturer: 01/06/2026
• Initial Report FDA Received Date: 11/17/2025
• Supplement Report FDA Received Date: 01/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/10/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 8F TALISMAN DS ( 9-TDS-08F45-80, 10421740).
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown