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

Catalog Number 9-ACP2-010-025

Device Problems Migration or Expulsion of Device (1395); Use of Device Problem (1670); Patient-Device Incompatibility (2682)

Patient Problems Angina (1710); Dyspnea (1816); Cardiac Tamponade (2226); Pericardial Effusion (3271)

Event Date 10/10/2023

Event Type  Injury  

Event Description

It was reported that on (b)(6) 2023, a 25mm amplatzer amulet left atrial appendage (laa) occluder was implanted successfully on the pulmonary ridge utilizing a 14f amplatzer torqvue delivery system.After release, the device was nudged by the delivery cable further into the appendage in a technique error by the physician.The patient presented with a friable laa with prominent transverse sinus.After the implantation, the patient was put on dual antiplatelet therapy as an anti-thrombotic regimen.On 26 november 2023, the patient developed dyspnea and angina.Further observation reveal pericardial effusion leading to cardiac tamponade.The patient was given heparin and pericardiocentesis was performed, removing 1400cc of fluid.The patient is reported to be stable.Anti-thrombotic regimen was not adjusted.The effusion was located behind the appendage on underside, and it was a slow leak the physician thought the pericardial effusion was caused by the migration of the device further into the laa by the delivery cable as the device was being released during the implantation procedure.The patient is reported to be 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 dyspnea and angina and pericardial effusion leading to 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 received, the cause of the reported incident may be due to the error that occurred during the procedure.There is no indication of a product quality issue with respect to labeling design or manufacturing 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: 18625777
• MDR Text Key: 334346768
• Report Number: 2135147-2024-00461
• Device Sequence Number: 1
• Product Code: NGV
• UDI-Device Identifier: 00811806013497
• UDI-Public: 00811806013497
• 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: 02/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 9-ACP2-010-025
• Device Lot Number: 8791221
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/02/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/06/2022
• 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): Hospitalization; Required Intervention; Life Threatening
• Patient Age: 76 YR
• Patient Sex: Female