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

Catalog Number 9-ACP2-007-020

Device Problem Contamination /Decontamination Problem (2895)

Patient Problem Thrombosis/Thrombus (4440)

Event Date 03/04/2024

Event Type  Injury  

Event Description

It was reported that on 04 march 2024, a 20mm amplatzer amulet left atrial appendage occluder was chosen for implant using a 14f amulet steerable delivery sheath.During the procedure, heparin was administered, and the activated clotting time (act) level was 207 seconds.The device was attempted to be implanted and was partially recaptured 3 times.The delivery system and device were removed to facilitate a second transseptal puncture.However, it was then noted on transesophageal echocardiogram (tee) that a thrombus was forming on the proximal portion of the laa.The case was aborted due to the thrombus formation.The patient will be treated and procedure will be attempted again at a later time.When the device was pulled back through the sheath post removal, and a filament was noted on the device.The patient status was reported as stable.

Manufacturer Narrative

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

Manufacturer Narrative

An event of thrombus formation on the proximal portion of the laa and filament noted on the device after removal from sheath was reported.A returned device inspection, to rule out any device-related causes, 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.No images were provided to confirm the reported event.Based on the information received, the cause of the reported incident could not be conclusively determined.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.

Event Description

It was reported that on (b)(6) 2024, a 20mm amplatzer amulet left atrial appendage occluder was chosen for implant using a 14f amulet steerable delivery sheath.During the procedure, heparin was administered, and the activated clotting time (act) level was 307 seconds.The device was attempted to be implanted and was partially recaptured 3 times.The delivery system and device were removed to facilitate a second transseptal puncture.However, it was then noted on transesophageal echocardiogram (tee) that a thrombus was forming on the proximal portion of the laa.The case was aborted due to the thrombus formation.The patient will be treated and procedure will be attempted again at a later time.When the device was pulled back through the sheath post removal, and a filament was noted on the device.The patient status was reported as stable.

• 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: 18997275
• MDR Text Key: 338880829
• Report Number: 2135147-2024-01379
• Device Sequence Number: 1
• Product Code: NGV
• UDI-Device Identifier: 00811806013473
• UDI-Public: (01)00811806013473(17)271231(10)8849684
• 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
• Report Date: 03/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 9-ACP2-007-020
• Device Lot Number: 8849684
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/04/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/19/2023
• 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 Outcome(s): Other
• Patient Age: 82 YR
• Patient Sex: Female