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

Catalog Number 9-PFO-2518

Device Problem Air/Gas in Device (4062)

Patient Problems Air Embolism (1697); Non specific EKG/ECG Changes (1817)

Event Date 01/16/2024

Event Type  Injury  

Event Description

It was reported that on (b)(6) 2024, an amplatzer talisman pfo occluder was chosen for implant using a 9f amplatzer torqvue delivery system.The patient was under conscious sedation.It was reported that the device was prepared per instructions for use (ifu) by the physician.During device preparation, there was no visible air on the loaded occluder prior to insertion into the patient.Once the dilator and wire were removed from the patient, the loader of the talisman pfo occluder was immediately attached to the delivery system using wet-to-wet connection.The wire and dilator were not removed too quickly or too slowly.The occluder was advanced without noting air in the system.After the left atrial and right atrial discs were placed, the physician stopped when st elevation was observed on electrocardiogram (ecg) for approximately two minutes.The st elevation was an indication of an air embolism.The st elevation subsided without intervention.No aspiration was being performed.The talisman pfo was successfully implanted.The patient status was stable and discharged.

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 (b)(6) 2024, an amplatzer talisman pfo occluder was chosen for implant using a 9f amplatzer torqvue delivery system.The patient was under conscious sedation.It was reported that the device was prepared per instructions for use (ifu) by the physician.During device preparation, there was no visible air on the loaded occluder prior to insertion into the patient.Once the dilator and wire were removed from the patient, the loader of the talisman pfo occluder was immediately attached to the delivery system using wet-to-wet connection.The wire and dilator were not removed too quickly or too slowly.The occluder was advanced and air was seen while advancing the occluder.After the left atrial and right atrial discs were placed, the physician stopped when st elevation was observed on electrocardiogram (ecg) for approximately two minutes.The st elevation was an indication of an air embolism.The st elevation subsided without intervention.No aspiration was being performed.The talisman pfo was successfully implanted.The patient status was stable and discharged.

Manufacturer Narrative

An event of air while loading the occluder into the delivery sheath was reported.A returned device inspection, to rule out any device-related causes, 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 of the reported incident could not be conclusively determined.Information from field indicated that no air entered the patient anatomy, and that the device was implanted successfully.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.

• 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: 18654970
• MDR Text Key: 334722386
• Report Number: 2135147-2024-00543
• Device Sequence Number: 1
• Product Code: MLV
• UDI-Device Identifier: 05415067033314
• UDI-Public: (01)05415067033314(17)260630(10)9158364
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P120021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 9-PFO-2518
• Device Lot Number: 9158364
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/16/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/25/2023
• 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
• Treatment: AMPLATZER TORQVUE DS, 9-ITV09F45/80, LOT 9020608.
• Patient Outcome(s): Other
• Patient Age: 33 YR
• Patient Sex: Female