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

Catalog Number	9-PFO-1818
Medical Device Problem Codes	Difficult to Fold, Unfold or Collapse (1254); Device Difficult to Setup or Prepare (1487)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/08/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on (b)(6) 2024, an 18-18mm amplatzer talisman pfo occluder was chosen for implant to close a patent foramen ovale (pfo) using an 8f amplatzer talisman delivery sheath.During device preparation, it was difficult to pull the device into the loader.When the device was deployed in the body, the right atrial disc of the device did not expand properly and showed a bulbous shape.Pushing with the sheath did not help.Contacts occurred with intracardiac tissue during the occluder deployment.The device was pulled back into the sheath with difficulty, and the device was replaced with another 18-18mm amplatzer talisman pfo occluder using the same delivery sheath.There were no bends or kinks been observed in the delivery sheath.The replacement device entered the loader without resistance and expanded properly in the body.After placement, the bubble test showed no residual shunt, and the procedure was completed successfully.
Additional Manufacturer Narrative
Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Additional Manufacturer Narrative
An event of difficulty to setting up device and device deformity could not be confirmed.The device was returned to abbott for investigation and the device met functional specifications when analyzed under non-physiological conditions.Images received appeared to show the device in bulbous deformation, however this cannot be confirmed.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed, and the product met all defined manufacturing specifications.The cause of the reported incidents could not be conclusively determined.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.Per the information available abbott cannot further speculate on why the reported events occurred.
Event or Problem Description
It was reported that on (b)(6) 2024, an 18-18mm amplatzer talisman pfo occluder was chosen for implant to close a patent foramen ovale (pfo) using an 8f amplatzer talisman delivery sheath.During device preparation, it was difficult to pull the device into the loader.When the device was deployed in the body, the right atrial disc of the device did not expand properly and showed a bulbous shape.Pushing with the sheath did not help.Contacts occurred with intracardiac tissue during the occluder deployment.The device was pulled back into the sheath with difficulty, and the device was replaced with another 18-18mm amplatzer talisman pfo occluder using the same delivery sheath.There were no bends or kinks been observed in the delivery sheath.The replacement device entered the loader without resistance and expanded properly in the body.After placement, the bubble test showed no residual shunt, and the procedure was completed successfully.

• 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: 20834422
• Report Number: 2135147-2024-06108
• Device Sequence Number: 8627974
• Product Code: MLV
• UDI-Device Identifier: 05415067033307
• UDI-Public: (01)05415067033307(17)270131(10)10205719
• 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: 2024
• Device Explanted Year: 2024
• 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): 02/02/2025

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 Catalogue Number: 9-PFO-1818
• Device Lot Number: 10205719
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/08/2024
• Supplement Date Received by Manufacturer: 01/30/2025
• Initial Report FDA Received Date: 12/03/2024
• Supplement Report FDA Received Date: 02/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/14/2024
• 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: AMPLATZER TALISMAN DELIVERY SHEATH, 9-TDS-08F45-80
• Patient Age: 50 YR
• Patient Sex: Female