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

Catalog Number 9-ACP2-007-022

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Cardiac Arrest (1762); Cardiac Tamponade (2226); Pericardial Effusion (3271)

Event Date 12/05/2023

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 on (b)(6) 2023, a 22mm amplatzer amulet left atrial appendage (laa) occluder was successfully implanted, using 12f amplatzer torqvue 45x45 delivery sheath.Max laa orifice 26mm and max landing zone 20mm.Post-procedure same day, the patient was found in a pulseless electrical activity (pea), requiring cardiopulmonary resuscitation (cpr).Bedside echocardiogram revealed cardiac tamponade, requiring pericardiocentesis with 340ml of blood being drained.A drain was sutured in place.At this time, blood pressure and rhythm stabilized.Tamponade was resolved and the patient was transferred to the intensive care unit (icu).On (b)(6) 2023, the patient was taken to the operation room (or) for emergent mediastinal exploration for cardiac tamponade with repair of the posterior main pa bleeding sites.Transthoracic echocardiogram (tte) performed on (b)(6) 2023 showing no pericardial effusion.Patient extubated on (b)(6) 2023 and was reported to be stable.This reportedly required prolonged hospital stay.

Manufacturer Narrative

An event of cardiac tamponade, requiring pericardiocentesis was reported.A returned device assessment could not be performed as the device remains implanted and was not returned for analysis.There are multiple risk factors for pericardial effusion after a left atrial appendage closure procedure, including anticoagulation status of the patient, maneuvering of the guidewire or sheaths within the heart, the trans-septal puncture, or the stabilizing wires on the amulet puncturing the laa.Information from field indicated that act was between 300-350.A medical review of images captured on a cellular device were received from the field was conducted and indicated that we have surgical confirmation of pa injury however, due to the limited images provided, this appears to be from unknown etiology and unable to confirm complete ifu use without the full case images.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 determined.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: 18426608
• MDR Text Key: 331866133
• Report Number: 2135147-2024-00001
• Device Sequence Number: 1
• Product Code: NGV
• 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: 02/08/2024

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-ACP2-007-022
• Device Lot Number: 8861913
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/06/2023
• Initial Date FDA Received: 01/02/2024
• Supplement Dates Manufacturer Received: 02/08/2024
• Supplement Dates FDA Received: 02/08/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/27/2023
• 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; Required Intervention; Hospitalization
• Patient Age: 70 YR
• Patient Sex: Female
• Patient Weight: 84 KG