MAUDE Adverse Event Report: ABBOTT MEDICAL; AMPLATZER AMULET DELIVERY SYSTEM

Model Number DS-TV45X45-12F-080

Device Problems Improper or Incorrect Procedure or Method (2017); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Thrombosis/Thrombus (4440)

Event Date 02/26/2021

Event Type  malfunction  

Manufacturer Narrative

The results, method, and conclusion codes along with investigation results will be provided in the final report.

Event Description

On (b)(6) 2021, a 25 mm amplatzer amulet left atrial appendage occluder was selected for implant.During the procedure, the device was prepared and advanced through the delivery sheath into the left atrial appendage.After two attempts, the device was fully recaptured into the delivery sheath in order to reposition the sheath into the left atrial appendage (laa).Resistance was noted resistance when trying to redeploy the device and it was decided to fully retrieve the device into the loader.Upon inspection, a thrombus was found on the device and the cable connected to the device.The physician suspected a clotting disorder as the cause.A larger heparin dose was administered and a new 25 mm amplatzer amulet left atrial appendage occluder and delivery system were used to complete the procedure.There was no clinically significant delay in the procedure and the patient remained hemodynamically stable throughout.The patient is stable.

Manufacturer Narrative

The reported event of thrombus on the device and cable could not be confirmed.A more comprehensive 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 of the reported incident could not be conclusively determined.Per the instructions for use (ifu) of the delivery sheath, artmt600034452 rev.B, "when placing a device using an amplatzer¿ amulet¿ delivery sheath, refer to the instructions for use provided with the device." the amulet ifu, artmt600034453 rev.C, states "if the device is retracted farther than the radiopaque markers (fully recaptured), the device and the sheath must both be removed and replaced.Failure to replace both the device and the sheath may result in sheath and/or device malfunction.".

• Type of Device: AMPLATZER AMULET DELIVERY SYSTEM
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 11554767
• MDR Text Key: 243755255
• Report Number: 2135147-2021-00107
• Device Sequence Number: 1
• Product Code: MLV
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 04/13/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2023
• Device Model Number: DS-TV45X45-12F-080
• Device Lot Number: 7390196
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/26/2021
• Initial Date FDA Received: 03/23/2021
• Supplement Dates Manufacturer Received: 04/09/2021
• Supplement Dates FDA Received: 04/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1