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

Catalog Number 9-ACP2-007-018

Device Problem Contamination /Decontamination Problem (2895)

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

Event Date 11/01/2023

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 20mm amplatzer amulet left atrial appendage occluder was chosen for implant using a 12f amplatzer amulet delivery sheath.The sizing was determined by fluoroscopy and transoesophageal echocardiogram (toe).During procedure, the activated clotting time (act) was 320 seconds.The 20mm device was advanced through delivery sheath and placed.It was noted that device was grossly oversized, and the decision was made to downsize.The 20mm device was removed from the patient prior to release from the delivery cable.The physician decided to not to change the sheath, and a new 18mm amplatzer amulet left atrial appendage occluder was chosen for implant.The 18mm amulet was prepared and delivered into the same delivery sheath and placed into appendage.On echocardiogram, a fiber was floating in left atrium.The 18mm device removed from the patient prior to release from the delivery cable.The device was withdrawn, and the long fiber was clearly able to be seen.A new 16mm amplatzer amulet left atrial appendage occluder was then prepared and placed using the same delivery system.It was noted that another fiber was floating in left atrium, and it was 2.1cm long.The device was implanted.The fiber was still seen on toe at the end of the procedure.The patient remained hemodynamically stable throughout the procedure.No further action was taken.

Event Description

Related manufacturer report number: 2135147-2023-05152.It was reported that on (b)(6) 2023, a 20mm amplatzer amulet left atrial appendage occluder was chosen for implant using a 12f amplatzer amulet delivery sheath.The sizing was determined by fluoroscopy and transoesophageal echocardiogram (toe).During procedure, the activated clotting time (act) was 320 seconds.The 20mm device was advanced through delivery sheath and placed.It was noted that device was grossly oversized, and the decision was made to downsize.The 20mm device was removed from the patient prior to release from the delivery cable.The physician decided to not to change the sheath, and a new 18mm amplatzer amulet left atrial appendage occluder was chosen for implant.The 18mm amulet was prepared and delivered into the same delivery sheath and placed into appendage.On echocardiogram, a fiber was floating in left atrium.The 18mm device removed from the patient prior to release from the delivery cable.The device was withdrawn, and the long fiber was clearly able to be seen.A new 16mm amplatzer amulet left atrial appendage occluder was then prepared and placed using the same delivery system.It was noted that another fiber was floating in left atrium, and it was 2.1cm long.The device was implanted.The fiber was still seen on toe at the end of the procedure.The patient remained hemodynamically stable throughout the procedure.No further action was taken.No additional information was provided.

Manufacturer Narrative

An event of fibers being present on the amulet device was confirmed.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and that the product met all specifications.The device was received for examination, which found small fibers, consistent with ptfe on the device.Four images were also received from the field appearing to show the device after implant, which also showed fibers attached to the occluder.The fiber was consistent with the ptfe inner liner of the delivery sheath.Information from the field indicated that the device was implanted through a previously used sheath, against the instructions for use.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 fibers from the damaged sheath can then get entangled onto the new amulet being advanced through the damaged sheath.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.Please note, per the instructions for use "warning: if the device is retracted farther than the radiopaque markers, do not readvance the device or perform injections.The device and the delivery sheath must both be removed and replaced.".

• 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: 18192740
• MDR Text Key: 328964410
• Report Number: 2135147-2023-05153
• Device Sequence Number: 1
• Product Code: NGV
• UDI-Device Identifier: 00811806013466
• UDI-Public: 00811806013466
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: 12/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 9-ACP2-007-018
• Device Lot Number: 8332806
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/09/2022
• 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-TV45X45-12F-080
• Patient Age: 81 YR
• Patient Weight: 70 KG