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

Catalog Number 9-PFO-3525

Device Problem Air/Gas in Device (4062)

Patient Problems Air Embolism (1697); Cardiac Arrest (1762)

Event Date 02/02/2024

Event Type  Death  

Manufacturer Narrative

Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event 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.

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
• Type of Device: 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
• MDR Text Key: 336351290
• Report Number: 2135147-2024-00873
• Device Sequence Number: 1
• Product Code: MLV
• UDI-Device Identifier: 05415067033345
• UDI-Public: (01)05415067033345(17)250731(10)8604640
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: P120021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 9-PFO-3525
• Device Lot Number: 8604640
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/26/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/08/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death