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

Catalog 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	01/07/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 35-25mm amplatzer talisman patent foramen ovale (pfo) occluder was selected for implant using a 9f amplatzer talisman delivery sheath.It was noted during procedure that the right atrial disc of the occluder exhibited a mushroom shaped deformation when being deployed.An attempt at pressing the sheath was against the occluder did not improve the situation.There was no contact with intracardiac tissue during the occluder deployment.There were no bends or kinks observed in the delivery sheath.The decision was made to recapture and remove the occluder prior to release from the delivery cable.The 35-25mm amplatzer talisman (pfo) occluder was replaced with another one of the same size to complete the procedure.There were no adverse patient consequences reported.
Additional Manufacturer Narrative
An event of device deformity was reported.A returned device inspection 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.Additionally, a review of the complaint history identified no similar incidents reported from this lot.Based on the available information, a cause of the reported incident could not be conclusively determined.There is no indication of a product quality issue with regards to manufacture, design, or labeling.

• Brand Name: AMPLATZER TALISMAN PFO OCCLUDER
• Common Device Name: TRANSCATHETER SEPTAL OCCLUDER
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane north; plymouth MN 55442
• Manufacturer (Section G): ABBOTT MEDICAL REG# 2135147; 5050 nathan ln n; plymouth MN 55442
• Manufacturer Contact: karen krouse ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 21282810
• Report Number: 2135147-2025-00479
• Device Sequence Number: 9320482
• Product Code: MLV
• UDI-Device Identifier: 05415067033345
• UDI-Public: (01)05415067033345(17)250831(10)8686850
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 02/21/2025

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 Expiration Date: 08/31/2025
• Device Catalogue Number: 9-PFO-3525
• Device Lot Number: 8686850
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/08/2025
• Supplement Date Received by Manufacturer: 02/16/2025
• Initial Report FDA Received Date: 01/31/2025
• Supplement Report FDA Received Date: 02/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/29/2022
• 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: AMPLATZER TALISMAN DS, 9-TDS-09F45-80 (10212779)
• Patient Sex: Unknown