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

Model Number	9-PFO-2518
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Cardiac Tamponade (2226); Pericardial Effusion (3271)
Date of Event	01/07/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that (b)(6) 2026, a 25-18mm ampaltzer talisman pfo occluder was implanted using 8f talisman delivery sheath.The procedure was performed through the existing pfo channel, and no pericardial effusion was noted prior to the procedure.The implantation proceeded without noted complications, with no difficulty implanting the device, no multiple manipulations, and no partial or full recaptures performed.The device was released in the desired position.During the procedure, the patient was in sinus rhythm.Heparin (5000 iu) was administered, but activated clotting time (act) was not measured due to the short procedure time.No protamine or other reversal agent was administered.No wire or sheath exchanges occurred, and the wire was not placed in the left atrial appendage, nor was it positioned in a pulmonary vein in a manner requiring multiple repositioning.The following morning, the patient developed cardiac tamponade.Imaging and surgical findings indicated that the pericardial effusion was circumferential and located at the right atrium roof.The largest dimension of the effusion was not measured, as the patient underwent emergency pericardiocentesis to evacuate blood.The patient had been taking dual antiplatelet therapy (aspirin and clopidogrel) both on the day of the procedure and at the time the effusion was detected.The patient subsequently underwent surgery, during which the pfo device was removed and the pfo was surgically closed.The patient has since recovered well.It was reported that the treating physicians had no explanation for the event; however, the user believes that the abbott pfo talisman device caused the pericardial effusion/cardiac tamponade.
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
N/a.
Additional Manufacturer Narrative
An event of a implant related tissue damage was reported with pericardial effusion and cardiac tamponade.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 implant related tissue damage could not be determined.The reported pericardial effusion and cardiac tamponade are likely cascading effects from the event.Interventions were results of case-specific circumstances, as a pericardiocentesis was performed, the device was surgically removed, and the pfo was closed.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: 24283861
• Report Number: 2135147-2026-00730
• Device Sequence Number: 9802975
• Product Code: MLV
• UDI-Device Identifier: 05415067033314
• UDI-Public: (01)05415067033314(17)280630(10)10973671
• Combination Product (Y/N): N
• Initial Reporter Country: NO
• 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): 03/26/2026

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-2518
• Device Catalogue Number: 9-PFO-2518
• Device Lot Number: 10973671
• 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: 01/14/2026
• Supplement Date Received by Manufacturer: 03/11/2026
• Initial Report FDA Received Date: 02/06/2026
• Supplement Report FDA Received Date: 03/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/29/2025
• 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 Sex: Unknown