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	01/07/2026
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
It was reported that on (b)(6) 2026, a 30-25mm amplatzer pfo occluder was chosen for implant using a 9f amplatzer torqvue delivery system.No pericardial effusion was noted prior to the procedure.The transseptal puncture was performed at the fossa.During the case, multiple manipulations and multiple wire exchanges occurred, with the wire positioned within the right atrium.The patient was in sinus rhythm at the time, of the procedure.The patient had been taking aspirin (apt) prior to the procedure and continued on aspirin at the time the effusion was detected.The patient also received enoxaparin 0.5 mg/kg during the procedure, and no protamine or other reversal agents were administered.A pericardial effusion was subsequently identified and was located within the pericardium, measuring 14 mm in its largest dimension and characterized as circumferential.The effusion was managed with pericardiocentesis, and the user did not believe the event was caused by an abbott device.
Event or Problem Description
It was reported that on (b)(6) 2026, a 30-25mm amplatzer pfo occluder was chosen for implant using a 9f amplatzer torqvue delivery system.No pericardial effusion was noted prior to the procedure.The transseptal puncture was performed at the fossa.During the case, multiple manipulations and multiple wire exchanges occurred, with the wire positioned within the right atrium.The patient was in sinus rhythm at the time, of the procedure.The patient had been taking aspirin (apt) prior to the procedure and continued on aspirin at the time the effusion was detected.The patient also received enoxaparin 0.5 mg/kg during the procedure, and no protamine or other reversal agents were administered.A pericardial effusion was subsequently identified and was located within the pericardium, measuring 14 mm in its largest dimension and characterized as circumferential.The effusion was managed with pericardiocentesis, and the user did not believe the event was caused by an abbott device.
Additional Manufacturer Narrative
An adverse event without identified device or use problem and pericardial effusion 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, the cause for the reported pericardial effusion could not be determined.An unexpected medical intervention was a result of case-specific circumstances, as a pericardiocentesis was performed.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: 24283538
• Report Number: 2135147-2026-00722
• Device Sequence Number: 9862206
• Product Code: MLV
• UDI-Device Identifier: 05415067033321
• UDI-Public: (01)05415067033321(17)280731(10)10996205
• 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: 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?: 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: 10996205
• 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: 01/12/2026
• Supplement Date Received by Manufacturer: 03/10/2026
• Initial Report FDA Received Date: 02/06/2026
• Supplement Report FDA Received Date: 03/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/13/2025
• 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 Age: 85 YR
• Patient Sex: Unknown