MAUDE Adverse Event Report: ABBOTT MEDICAL AMPLATZER TALISMAN DELIVERY SHEATH; CATHETER, PERCUTANEOUS

Catalog Number 9-TDS-09F45-80

Device Problems Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017); Adverse Event Without Identified Device or Use Problem (2993); Air/Gas in Device (4062)

Patient Problems Air Embolism (1697); Bradycardia (1751); Cardiac Arrest (1762); Embolism/Embolus (4438); Heart Block (4444)

Event Date 10/13/2023

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 (b)(6) 2023, amplatzer talisman pfo occluder 35-25mm was selected for an implant using a 9f amplatzer talisman delivery sheath.The amplatzer talisman delivery sheath full inner pouch had been re-sterilized even though it had never been used.During the procedure, the occluder was delivered and correctly implanted in the patient.The delivery system and positioning sheath were removed, minutes later the patient experienced bradycardia and atrioventricular block, resuscitation maneuvers were performed with an external pacemaker without success.It was reported that the patient passed away due to severe embolism.

Event Description

(b)(4).It was reported that on (b)(6) 2023, amplatzer talisman pfo occluder 35-25mm was selected for an implant using a 9f amplatzer talisman delivery sheath.The amplatzer talisman delivery sheath full inner pouch had been re-sterilized even though it had never been used.During the procedure, the occluder was delivered and correctly implanted in the patient.The delivery system and positioning sheath were removed, minutes later the patient experienced bradycardia and atrioventricular block, resuscitation maneuvers were performed with an external pacemaker without success.It was reported that the patient passed away due to severe embolism.

Manufacturer Narrative

An event of arrhythmia, embolism and patient death was reported.The device was returned to abbott, and the investigation confirmed no damage or kinks found on the loader and delivery sheath.The loader was connected to the hemostasis valve, which was connected to the extension tube and stopcock.The delivery cable was inserted through the hemostasis valve and tightened.The loader was connected to the sheath.A syringe was attached to the stopcock, and the components were flushed with water.No leaks or bubbles were found.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 death was due to severe embolism.However, the cause of embolism could not be conclusively determined.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.From medical review: "it is unclear what was the source of the embolism, but it is presumed to have been an air embolism.Heart block following pfo closure is a known potential adverse event that may be due to the device compressing the conduction system; however, it is unknown if this was the cause for the heart block in this event and it is reported to have been related to an embolism."h6 health effect - clinical codes 4438 was removed.H6 medical device problem code 2993 was removed.

• Brand Name: AMPLATZER TALISMAN DELIVERY SHEATH
• Type of Device: CATHETER, PERCUTANEOUS
• 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: 18097507
• MDR Text Key: 327696798
• Report Number: 2135147-2023-04945
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: K212738
• 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: 01/04/2024
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 9-TDS-09F45-80
• Device Lot Number: 8856812
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/14/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/24/2023
• 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
• Patient Outcome(s): Death
• Patient Age: 64 YR
• Patient Sex: Male
• Patient Weight: 93 KG