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

Catalog Number 9-ACP2-010-031

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Low Blood Pressure/ Hypotension (1914); Cardiac Tamponade (2226); Pericardial Effusion (3271)

Event Date 01/26/2024

Event Type  Injury  

Manufacturer Narrative

The device will not be returned for evaluation as the device was reportedly discarded.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.Na.

Event Description

It was reported that on (b)(6) 2024, a 31mm amplatzer amulet left atrial appendage occluder was chosen for implant using a 14f amplatzer torqvue 45x45 delivery sheath.The patient had a chicken wing anatomy.During procedure, the activated clotting time (act) level was 344 seconds and heparin was administered.Due to difficult anatomy there was some difficulties for implanting the device.The patient had a drop in blood pressure, and transesophageal echocardiogram (tee) showed a pericardial effusion.The pericardial effusion lead to cardiac tamponade.The device was taken out of the body, and a pericardiocentesis was performed.The procedure was aborted, and patient stayed in the hospital overnight.The physician confirmed the cause of effusion was amulet device.The patient was reported stable.It was reported that on (b)(6) 2024, a 31mm amplatzer amulet left atrial appendage occluder was chosen for implant using a 14f amplatzer torqvue 45x45 delivery sheath.The patient had a chicken wing anatomy.During procedure, the activated clotting time (act) level was 344 seconds and heparin was administered.Due to difficult anatomy there was some difficulties for implanting the device.The patient had a drop in blood pressure, and transesophageal echocardiogram (tee) showed a pericardial effusion.The pericardial effusion lead to cardiac tamponade.The device was taken out of the body, and a pericardiocentesis was performed.The procedure was aborted, and patient stayed in the hospital overnight.The physician confirmed the cause of effusion was amulet device.The patient was reported stable.

Manufacturer Narrative

An event of low blood pressure/hypotension, pericardial effusion, and cardiac tamponade was reported.A returned device assessment could not be performed as the device 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.Reportedly, the patient had a chicken wing anatomy.There was some difficulties for implanting the device due to difficult anatomy.The patient had a drop in blood pressure, and transesophageal echocardiogram (tee) showed a pericardial effusion.The pericardial effusion lead to cardiac tamponade.The device was taken out of the body, and a pericardiocentesis was performed.The procedure was aborted, and patient stayed in the hospital overnight.The patient was reported stable.Based on the information received, the cause of the reported incident could not be conclusively determined.There is no indication of a product quality issue with regards to manufacture, design, or labeling.

• 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: 18739950
• MDR Text Key: 335765968
• Report Number: 2135147-2024-00751
• Device Sequence Number: 1
• Product Code: NGV
• UDI-Device Identifier: 00811806013510
• UDI-Public: 00811806013510
• 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: 03/06/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 9-ACP2-010-031
• Device Lot Number: 8724576
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/29/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/24/2022
• 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): Required Intervention; Hospitalization; Life Threatening
• Patient Age: 75 YR
• Patient Sex: Male