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

Catalog Number	9-PFO-3525
Medical Device Problem Code	Air/Gas in Device (4062)
Health Effect - Clinical Codes	Air Embolism (1697); Cardiac Arrest (1762)
Date of Event	02/02/2024
Type of Reportable Event	Death
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 02 february 2024, a 35-25mm amplatzer talisman pfo occluder was chosen for a patent foramen ovale (pfo) closure using a 9f amplatzer talisman delivery sheath.During procedure, the patient was under deep sedation, the physician advanced the dilator and delivery sheath over the guidewire through the pfo and into the left atrium and removed the dilator and the guidewire before connecting the loader, during backflow, trans-esophageal echocardiogram (toe) revealed bubbles in the left atrium.The physician mentioned an hypothesis of pressure inversion which led to air embolism from the delivery system.The physician attached the loader to the delivery sheath (in a wet-to-wet condition) and positioned the device, patient had cardiac arrest.The physician made several maneuvers to recover the patient, and the device was not released and got recaptured.The patient passed away.The cause of death was irreversible cardiac arrest.
Additional Manufacturer Narrative
An event of air in device, air embolism (air in the left atrium), cardiac arrest, and death was reported.A returned device assessment 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 specifications.Based on the information received, the cause for reported patient effects air embolism (air in the left atrium) led to cardiac arrest appears to be related to air in the device.However, the reported air in device could not be conclusively determined.It is possible due to procedural conditions (possible due to the pressure inversion which led to air embolism from the delivery system.); however, this cannot be confirmed.Per case detail, the reported death is related to irreversible cardiac arrest and related to procedure.In addition, embolism is a possible outcome of the procedure per the amplatzer talisman delivery system instructions for use.

• 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: 18790019
• Report Number: 2135147-2024-00873
• Device Sequence Number: 15539698
• Product Code: MLV
• UDI-Device Identifier: 05415067033345
• UDI-Public: (01)05415067033345(17)250731(10)8604640
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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): 04/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2025
• Device Catalogue Number: 9-PFO-3525
• Device Lot Number: 8604640
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/02/2024
• Supplement Date Received by Manufacturer: 03/26/2024
• Initial Report FDA Received Date: 02/27/2024
• Supplement Report FDA Received Date: 04/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/08/2022
• 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
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Unknown