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

Model Number	9-PFO-3525
Medical Device Problem Code	Difficult to Fold, Unfold or Collapse (1254)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/27/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on (b)(6) 2025, a 30-25mm amplatzer talisman pfo occluder was chosen for implant using an unknown delivery system for a pfo closure in a patient with recent stroke.Transoesophageal echocardiography (toe) revealed an aneurysmal septum, a long tunnel pfo, and a triangulated fenestrated web connecting the pfo tunnel to the left side of the heart.The 30-25 mm amplatzer talisman pfo occluder was deployed but did not sit flat; the left atrial (la) disc did not reach the tunnel, and the right atrial (ra) disc at the aortic end posed a risk of entering the tunnel and causing embolization.The device was upsized to a 35-25 mm amplatzer talisman pfo occluder; however, the device again did not sit flat, and significant bubbles were observed passing through and around the device on bubble study post-deployment.The transseptal puncture was made anterior to the aortic valve.The 35-25 mm device was reprepped, but difficulty was encountered while loading it back into the loader after flushing.When advanced out of the loader on the table, the ra disc appeared bulbous.The procedure was completed using a new 35-25 mm amplatzer talisman pfo occluder.The patient remained hemodynamically stable throughout the procedure.No clinically significant delay occurred, and no adverse patient effects were reported.
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.
Additional Manufacturer Narrative
An event of device deformity was reported.A returned device assessment could not be performed as the device was not returned for analysis.One image was received from the field showing the device deformed into a bulbous shape outside of the patient.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 information received, 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 30-25mm amplatzer talisman pfo occluder was chosen for implant using an 9f amplatzer talisman delivery system for a pfo closure in a patient with recent stroke.Transoesophageal echocardiography (toe) revealed an aneurysmal septum, a long tunnel pfo, and a triangulated fenestrated web connecting the pfo tunnel to the left side of the heart.The 30-25 mm amplatzer talisman pfo occluder was deployed but did not sit flat; the left atrial (la) disc did not reach the tunnel, and the right atrial (ra) disc at the aortic end posed a risk of entering the tunnel and causing embolization.The device was upsized to a 35-25 mm amplatzer talisman pfo occluder; during the procedure, the device again did not sit flat, and significant bubbles were observed passing through and around the device on bubble study post-deployment.The transseptal puncture was made anterior to the aortic valve.The 35-25 mm device was reprepped, but difficulty was encountered while loading it back into the loader after flushing.When advanced out of the loader on the table, the ra disc appeared bulbous.The procedure was completed using a new 35-25 mm amplatzer talisman pfo occluder.The patient remained hemodynamically stable throughout the procedure.No clinically significant delay occurred, and no adverse patient effects were reported.

• 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: 23872890
• Report Number: 2135147-2025-07611
• Device Sequence Number: 14587428
• Product Code: MLV
• UDI-Device Identifier: 05415067033345
• UDI-Public: (01)05415067033345(17)280131(10)10726312
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: P120021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 01/22/2026

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 9-PFO-3525
• Device Catalogue Number: 9-PFO-3525
• Device Lot Number: 10726312
• 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: 11/27/2025
• Supplement Date Received by Manufacturer: 01/12/2026
• Initial Report FDA Received Date: 12/22/2025
• Supplement Report FDA Received Date: 01/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/18/2025
• 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
• Patient Age: 59 YR
• Patient Sex: Male
• Patient Weight: 80 KG