MAUDE Adverse Event Report: ABBOTT MEDICAL AMPLATZER AMULET; CARDIAC PLUG

Model Number 9-ACP2-010-025

Device Problem Contamination /Decontamination Problem (2895)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/02/2023

Event Type  malfunction  

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, a 22mm amplatzer amulet left atrial appendage occluder was chosen for implant using a 14f amplatzer steerable delivery sheath.The 22mm device was partially recaptured, fully recaptured and attempted to implant more than 3 times.It was reported that the patient had a complex anatomy, and the device could not be implanted due to the patient anatomy.A 25mm amplatzer amulet left atrial appendage occluder was attempted for implant with the same 14f amplatzer steerable delivery sheath.The 25mm device was also attempted to implant, partially recaptured and fully recaptured more than 3 times.Neither device could be implanted.When the 25mm amplatzer amulet left atrial appendage occluder was removed from the delivery sheath, a strand of what appeared to be fabric was wrapped around the device.There was no fabric observed inside the patient.The case was aborted.There were no adverse patient effects reported.The patient was reported as stable.

Manufacturer Narrative

An event of a strand of "fabric" being wrapped around an amulet device was reported.A returned device assessment could not be performed as the device and the substance 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.Information form the field indicated the device was partially and fully retracted into the sheath more than 3 times.Based on the information received, the cause of the reported event could not be conclusively determined but could be as a result of multiple full retractions of the device.Please note per the instructions for use: ¿ 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.

• Brand Name: AMPLATZER AMULET
• Type of Device: CARDIAC PLUG
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane n; plymouth MN 55442
• Manufacturer (Section G): ST. JUDE MEDICAL #3014918977; edificio #44 calle 0, ave. 2; el coyol alajuela 1897- 4050; CS 1897-4050
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 16619654
• MDR Text Key: 312860820
• Report Number: 2135147-2023-01355
• Device Sequence Number: 1
• Product Code: NGV
• UDI-Device Identifier: 00811806013497
• UDI-Public: 00811806013497
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P200049
• 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: 04/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9-ACP2-010-025
• Device Catalogue Number: 9-ACP2-010-025
• Device Lot Number: 8637648
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/14/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/29/2022
• 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 Sex: Male