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

Model Number 9-ACP2-010-025

Device Problems Improper or Incorrect Procedure or Method (2017); Contamination /Decontamination Problem (2895)

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

Event Date 12/12/2022

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 12 december 2022, a 28mm amplatzer amulet left atrial appendage occluder was chosen for implant using a 14f amplatzer steerable delivery sheath.Several attempts were made to make the 28mm amulet occluder fit, but the patient had severely prominent pectinate muscle, which was causing the device to push out.It was noted that the device was fully retracted into the delivery system at one point.The device was removed and swapped with a 25mm amplatzer amulet left atrial appendage occluder using the same delivery sheath.The 25mm amulet occluder also was not able to be implanted due to the prominent pectinate muscles.When the decision was made to resheath and remove the device, it was observed that there were strands of the sheath present on the occluder after it was pulled out of the sheath.No device was implanted, and the case was aborted.The patient remained hemodynamically stable throughout the procedure.There were no adverse patient effects.The patient status was reported as stable.

Manufacturer Narrative

An event of strands of a delivery sheath being observed on 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 loaded into an amplatzer steerable sheath that had been used several times with another occluder with at least one complete retraction, against the instructions for use.There was no allegation against the amulet device.Based on the information received, the use of the same sheath after multiple manipulations, with a new occluder could have lead to the inner lining of the sheath being transferred onto the new occluder thus causing the reported incident.There is no indication of a product quality issue with regards to manufacture, design, or labeling.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: 16233098
• MDR Text Key: 308498931
• Report Number: 2135147-2023-00267
• 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: 01/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2023
• 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: 8637647
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/30/2023
• 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
• Treatment: AMPLATZER AMULET LAA OCCLUDER, 9-ACP2-010-025; AMPLATZER AMULET LAA OCCLUDER, 9-ACP2-010-028; AMPLATZER STEERABLE DELIVERY SHEATH, ASDS-14F-075
• Patient Age: 74 YR
• Patient Sex: Female