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

Catalog Number 9-ACP2-007-020

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Erosion (1750); Cardiac Tamponade (2226); Pericardial Effusion (3271)

Event Date 01/08/2024

Event Type  Injury  

Event Description

It was reported that on (b)(6) 2022, a 20mm amplatzer amulet left atrial appendage occluder was implanted in a patient.On (b)(6) 2024, the patient presented to hospital with cardiac tamponade.The physician insinuated that the amulet device eroded through the pulmonary artery tissue, causing leak into the pericardial space.The patient was taken to surgery where a pericardial window was made, and the epicardium was drained.The amulet occluder remained implanted.The patient status was stable and recovering from a recent stroke.

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) 2022, a 20mm amplatzer amulet left atrial appendage (laa) occluder was implanted in a patient.Post procedure, the patient's anti-thrombotic regimen was dual antiplatelet therapy (dapt), which included aspirin and plavix, which was taken from (b)(6) 2022 to (b)(6) 2022.On (b)(6) 2024, the patient had a stroke.Per cardiologist, it was unable to be determined if the stroke was related to the performance of the implanted device.On (b)(6) 2024, the patient presented to hospital with cardiac tamponade.The physician insinuated that the amulet device eroded through the pulmonary artery tissue, causing leak into the pericardial space.The patient was taken to surgery where a pericardial window was made, and the epicardium was drained.300 ml of fluid and blood clot was removed from the pericardium, and a drain was placed.The surgeon stated that the pulmonary artery was intact.The effusion was a result of the amulet occluder slightly protruding through the wall of the laa.The amulet occluder remained implanted.Patient was scheduled to resume dapt with aspirin and plavix.The patient status was stable.

Manufacturer Narrative

An event of stroke and cardiac tamponade was reported.A returned device assessment could not be performed as the device remains implanted and was not returned for analysis.However, imaging received from the field were reviewed and revealed that the part of the amulet device that was ¿slightly protruding through the wall of the laa¿ was likely the disc.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed, and the product met all specifications.Based on the information received, the cause of the reported incident could not conclusively be determined but may have been due to the orientation of the device.

• 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: 18615057
• MDR Text Key: 334216900
• Report Number: 2135147-2024-00422
• Device Sequence Number: 1
• Product Code: NGV
• UDI-Device Identifier: 00811806013473
• UDI-Public: (01)00811806013473(17)261031(10)8233448
• 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: 04/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2024
• 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: 8233448
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/03/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/22/2021
• 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): Required Intervention; Life Threatening; Hospitalization
• Patient Age: 71 YR
• Patient Sex: Female