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

Catalog Number 9-ACP2-010-031

Device Problem Contamination /Decontamination Problem (2895)

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

Event Date 11/27/2023

Event Type  malfunction  

Event Description

It was reported that on (b)(6) 2023, a 28mm amplatzer amulet left atrial appendage occluder was chosen for implant using an amplatzer amulet delivery sheath.During the procedure, the patient was administered heparin, and the activated clotting time (act) levels were 250-280 seconds.During the procedure, the 28mm amulet was placed, but the device was too small for the patient's anatomy.The 28mm amulet occluder was removed and replaced with a 31mm amplatzer amulet laa occluder using the same delivery sheath.The physician was aware that this was not according to the instructions for use (ifu).The 31mm amulet occluder was deployed and placed in the laa.The device was still connected to the delivery cable, and a string-like formation at the end of the delivery sheath was observed.Initially, the formation was believed to be a thrombus.However, the delivery sheath was removed from the patient, and a few white threads were seen on the distal tip of the delivery cable.The origin of the threads was unknown.The patient remained hemodynamically stable throughout the procedure.There was no clinically significant delay in procedure and no adverse patient effects.The patient was reported to be discharged.

Manufacturer Narrative

Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Manufacturer Narrative

An event of a few white threads was seen on the distal tip of the delivery cable was reported.The investigation at abbott found one white thread on the distal tip of the delivery cable consistent with the ptfe inner lining of the delivery sheath.No other anomalies were noted.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed, and the product met all specifications.A video from field appeared to show an echocardiogram image of a cable released amulet device within the laa, and multiple filamentous strands of material extending from the distal portion of the delivery system.The strands were moving within the la but appeared to be attached to the delivery system.The fiber was consistent with the ptfe inner liner of the delivery sheath.The retraction of an amulet into the sheath (during removal of the occluder from the patient) is a known cause of delivery system damage.The material noted on the delivery cable is consistent with damage occurring to the sheath when the device is fully recaptured.Information from the field indicated that the 31 mm device was implanted through a previously used sheath, against the instructions for use.Please note that, 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: 18357319
• MDR Text Key: 331226931
• Report Number: 2135147-2023-05577
• Device Sequence Number: 1
• Product Code: NGV
• Combination Product (y/n): N
• Reporter Country Code: FI
• PMA/PMN Number: P200049
• 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: 02/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 9-ACP2-010-031
• Device Lot Number: 8745674
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/20/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/04/2022
• 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 DS, DS-TV45X45-14F-080