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

Catalog Number 9-ACP2-010-028

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Angina (1710); Pericardial Effusion (3271)

Event Date 10/30/2023

Event Type  Injury  

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 a 28mm amplatzer amulet left atrial appendage occluders was selected for implant on (b)(6) 2023 using a 14f amplatzer torqvue 45x45 delivery sheath.The device was successfully implanted.Post implant, the patient was on dual anti-platelet therapy (dapt).On 23 october 2023, a 45-day post-implant computed tomography (ct) scan was performed, and a pericardial effusion was noted.On (b)(6) 2023, the patient presented to the emergency department with chest pain.The pericardial effusion was noted to be mild to moderate and circumferential, measured at 1cm.Serial echocardiograms were performed on (b)(6) 2023.No pericardiocentesis was required.The patient was continued on dapt.It was believed that the pericardial effusion was due to the implanted amulet occluder.The patient status was stable.

Manufacturer Narrative

An event of pericardial effusion and cardiac tamponade was reported.A returned device assessment could not be performed as the device remains implanted and 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.Based on the information and imaging received, the cause of the reported incident could not be conclusively determined but is potentially consistent with stabilizing wire perforation of the laa wall.

• 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: 18628159
• MDR Text Key: 334367986
• Report Number: 2135147-2024-00464
• Device Sequence Number: 1
• Product Code: NGV
• UDI-Device Identifier: 00811806013503
• UDI-Public: (01)00811806013503(17)270930(10)8730445
• 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

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 9-ACP2-010-028
• Device Lot Number: 8730445
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/10/2024
• Initial Date FDA Received: 02/01/2024
• Supplement Dates Manufacturer Received: 04/03/2024
• Supplement Dates FDA Received: 04/04/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/27/2022
• 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
• Patient Outcome(s): Other
• Patient Age: 83 YR
• Patient Sex: Female