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	09/04/2024
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 a 30-25mm amplatzer talisman pfo occluder was selected for implant on (b)(6) 2024 using a 9f amplatzer talisman delivery sheath to close a patent foramen ovale (pfo).During device preparation it was noted that the device appeared to have no waist and looked to be shaped as one bubble.The decision was made to replace the device.No other 30-25mm sized occluder was available so a 35-25mm amplatzer talisman pfo occluder was selected as a replacement.During implant it was noted that the skirt of the device was too close in proximity to the aorta and the device took on a bubble shape.The occluder and delivery sheath were both removed from the patient and replaced with a 25mm amplatzer multi-fenestrated septal occluder - cribriform and 8f amplatzer trevisio intravascular delivery system to complete the procedure.The patient status was stable.
Additional Manufacturer Narrative
An event of device deformity noted during procedure 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.Images received appeared to show device in bulbous deformation.Based on the information received, the cause of the reported device deformity 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 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: 20359615
• Report Number: 2135147-2024-04864
• Device Sequence Number: 15468594
• Product Code: MLV
• UDI-Device Identifier: 05415067033345
• UDI-Public: (01)05415067033345(17)260430(10)9037698
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• 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): 11/27/2024

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: 04/30/2026
• Device Catalogue Number: 9-PFO-3525
• Device Lot Number: 9037698
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/09/2024
• Supplement Date Received by Manufacturer: 11/22/2024
• Initial Report FDA Received Date: 10/03/2024
• Supplement Report FDA Received Date: 11/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/10/2023
• 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: 9F AMPL TAL DS [9-TDS09F4580, LOT: 9048399]
• Patient Age: 36 YR
• Patient Sex: Female