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 Code	Pericardial Effusion (3271)
Date of Event	07/22/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported on (b)(6) 2026, a 30-25mm amplatzer talisman pfo occluder was chosen for an implant.During the patent foramen ovale (pfo) closure procedure, there was no reported difficulty implanting the device itself; however, the physician experienced difficulty crossing the pfo defect.To facilitate crossing, an sl1 sheath was used to support a guidewire.Multiple wire and delivery sheath exchanges were performed during attempts to cross the pfo defect.The physician successfully crossed the pfo without any signs of issues.During the procedure, heparin was administered; however, the amount was unknown.The valve was not re-sheathed more than two times.The 25 mm amplatzer talisman pfo occluder was subsequently delivered and released.Following device release, all delivery sheaths and wires were removed from the patient, and the venous access site was closed.While the patient was being transferred to a transport bed, the patient was noted to be unresponsive to nursing staff and was found to have a blood pressure of approximately 60/25 mmhg.The patient was returned to the catheterization laboratory table, where a circumferential pericardial effusion was identified.A pericardiocentesis was performed and approximately 1 liter of fluid was drained.The physician did not believe the pericardial effusion was related to the abbott device and believed it was caused by catheter maneuvers performed during the procedure.The patient remained hospitalized overnight for observation.The patient was reported to be doing well and was expected to be discharged home.
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.

• 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 ; +1(651)756-5400
• MDR Report Key: 50261814
• Report Number: 2135147-2026-05622
• Device Sequence Number: 18703854
• Product Code: MLV
• UDI-Device Identifier: 05415067033321
• UDI-Public: (01)05415067033321(17)280731(10)10983717
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P120021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted 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
• Report Date (Section B): 08/14/2026

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-3025
• Device Catalogue Number: 9-PFO-3025
• Device Lot Number: 10983717
• 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: 07/22/2026
• Initial Report FDA Received Date: 08/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/05/2025
• 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