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

Catalog Number 9-ACP2-010-025

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Hemorrhage/Bleeding (1888); Low Blood Pressure/ Hypotension (1914); Cardiac Tamponade (2226); Cardiac Perforation (2513); Pericardial Effusion (3271)

Event Date 10/12/2023

Event Type  Injury  

Event Description

It was reported that on (b)(6) 2023, a 25mm amplatzer amulet left atrial appendage occluder was chosen for implant with a 14f amplatzer torqvue 45x45 delivery sheath.It was reported the patient was administered heparin and their activated clotting time (act) levels were 300 seconds during procedure.While the device was still in the ball shape, the user attempted to advance the device deeper into the left atrial appendage (laa) but noted the anatomy of the laa was very steep and difficult to slide or position the device down deeply into the laa.After repeated failure to get the device into the landing zone, it was noted the patient had developed a 6-8mm pericardial effusion located in the pericardium at the right ventricle.It was reported the pericardial effusion developed into cardiac tamponade.The patient also experienced a drop in blood pressure.A decision was made to immediately abort the procedure and perform a pericardiocentesis.The device had been partially recaptured a total of two times during the procedure before it was removed from the patient.It was reported approximately 0.5l of blood was drained until no more blood in the pericardium could be seen via transesophageal echocardiography (tee).The patient then received several blood transfusions.A decision was then made to surgically amputate the left atrial appendage that same day and it was found there was a small perforation/hole in the left atrial appendage.The patient status was reported recovering.

Manufacturer Narrative

An event of pericardial effusion that lead to cardiac tamponade requiring pericardiocentesis and drop in blood pressure 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 could not be conclusively determined, however is consistent with deployment difficulties.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: 18041126
• MDR Text Key: 326987675
• Report Number: 2135147-2023-04796
• Device Sequence Number: 1
• Product Code: NGV
• UDI-Device Identifier: 00811806013497
• UDI-Public: 00811806013497
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P200049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2023
• 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: 8923297
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/12/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/03/2023
• 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
• Treatment: AMPLATZER TORQVUE 45X45 DS, DS-TV45X45-14F-080
• Patient Outcome(s): Required Intervention