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

Model Number	9-PFO-1818
Medical Device Problem Codes	Difficult to Fold, Unfold or Collapse (1254); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/11/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is expected to be returned for investigation.It has not yet been received.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 25-18mm amplatzer talisman pfo occluder was chosen for a patent foramen ovale (pfo) with a non-prominent atrial septal aneurysm (asa) closure procedure using an 8f amplatzer talisman delivery sheath.After corresponding echocardiographic measurements, the device was selected.During procedure, the transesophageal echocardiogram (tee) showed an lax interatrial septum, characterized by a marked, highly mobile bulging toward the right heart chamber's and the device exhibits significant mobility.There was no report of any interaction with cardiac structures during deployment and no report of any angulation/kink noticed with the delivery system.They decided to change the device and a new 25-18mm amplatzer talisman pfo occluder was chosen and implanted successfully.There was no clinically significant delay in procedure and no adverse consequences to the patient.The patient remained hemodynamically stable throughout the procedure.The patient was reported stable.
Additional Manufacturer Narrative
An event of mis-sizing of the device was reported.The device was returned to abbott for investigation and the device met functional specifications when analyzed under non-physiological conditions.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.The cause of the reported incident could not be conclusively determined.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 that on (b)(6) 2025, a 25-18mm amplatzer talisman pfo occluder was chosen for a patent foramen ovale (pfo) with a non-prominent atrial septal aneurysm (asa) closure procedure using an 8f amplatzer talisman delivery sheath.After corresponding echocardiographic measurements, the device was selected.During procedure, the transesophageal echocardiogram (tee) showed an lax interatrial septum, characterized by a marked, highly mobile bulging toward the right heart chamber's and the device exhibits significant mobility du to mis-sizing.There was no report of any interaction with cardiac structures during deployment and no report of any angulation/kink noticed with the delivery system.They decided to change the device and a new 25-18mm amplatzer talisman pfo occluder was chosen and implanted successfully.There was no clinically significant delay in procedure and no adverse consequences to the patient.The patient remained hemodynamically stable throughout the procedure.The patient was reported stable.

• 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: 22977191
• Report Number: 2135147-2025-04993
• Device Sequence Number: 15810128
• Product Code: MLV
• UDI-Device Identifier: 05415067033307
• UDI-Public: (01)05415067033307(17)270131(10)10210707
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: P120021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted 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): 11/13/2025

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 9-PFO-1818
• Device Catalogue Number: 9-PFO-1818
• Device Lot Number: 10210707
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/11/2025
• Supplement Date Received by Manufacturer: 10/31/2025
• Initial Report FDA Received Date: 09/05/2025
• Supplement Report FDA Received Date: 11/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/19/2024
• 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 AMPLATZER TALISMAN DELIVERY SHEATH, 9-TDS-08F45.
• Patient Age: 52 YR
• Patient Sex: Female
• Patient Weight: 63 KG