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

Model Number	9-PFO-3025
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Angina (1710); Pericardial Effusion (3271)
Date of Event	01/01/2026
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) 2025, a 30-25mm amplatzer talisman pfo occluder was chosen for implant using a 9f talisman delivery system.During the implant, the patient was in sinus rhythm (sinusal), and heparin was administered (reported as 7,200 units).No pericardial effusion was noted prior to the procedure.In (b)(6) 2026, approximately nine months after the implantation, the patient developed chest pain, and subsequent evaluation identified a pericardial effusion located within the pericardium.At the time the effusion was detected, heparin was administered, and the patient later underwent open-heart surgery involving the aorta and right atrium.The occluder device was not explanted, as its position was considered appropriate and it had become endothelialized.The user did not believe the abbott device caused the pericardial effusion, noting that the device remained in place.The pericardial effusion was resolved by open-heart surgery.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
An adverse event without identified device or use problem was reported with angina and pericardial effusion.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.Additionally, the lot was reviewed for similar complaints, and there is no indication of a lot-specific product issue.Based on the available information, the cause for the reported pericardial effusion could not be determined.The reported angina is a likely a cascading effect from the pe, however this cannot be determined.A surgical intervention was a result of case specific circumstances, as the pe was treated surgically.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: 24536201
• Report Number: 2135147-2026-01438
• Device Sequence Number: 16045239
• Product Code: MLV
• UDI-Device Identifier: 05415067033321
• UDI-Public: (01)05415067033321(17)271231(10)10667326
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 03/24/2026

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-3025
• Device Catalogue Number: 9-PFO-3025
• Device Lot Number: 10667326
• 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: 02/09/2026
• Supplement Date Received by Manufacturer: 03/14/2026
• Initial Report FDA Received Date: 03/06/2026
• Supplement Report FDA Received Date: 03/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/09/2025
• 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