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

Catalog Number 9-ACP2-010-031

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Atrial Fibrillation (1729); Low Blood Pressure/ Hypotension (1914); Nausea (1970); Pericardial Effusion (3271)

Event Date 10/04/2023

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 31mm amplatzer amulet left atrial appendage occluder was implanted with a 14f amplatzer torqvue 45x45 delivery sheath.During procedure, the patient was administered heparin.It was reported there was only one single deployment attempt.It was then reported 48 hours post-procedure, the patient presented with hypotension, nausea, rapid atrial fibrillation, and a moderate pericardial effusion.It was reported the pericardial effusion was located at the left atrial appendage and led to cardiac tamponade.A decision was made to perform a pericardiocentesis.It was reported the patient's rapid atrial fibrillation could not be stabilized with pharmacological intervention and a decision was made to perform cardioversion treatment but patient did not convert from atrial fibrillation to sinus rhythm.The patient status was reported as stable.

Manufacturer Narrative

An event of atrial fibrillation, nausea, low blood pressure/hypotension, and pericardial effusion 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.Reportedly, after post-procedure, the patient presented with hypotension, nausea, rapid atrial fibrillation, and a moderate pericardial effusion.It was reported the pericardial effusion was located at the left atrial appendage and led to cardiac tamponade.A decision was made to perform a pericardiocentesis.It was reported the patient's rapid atrial fibrillation could not be stabilized with pharmacological intervention and a decision was made to perform cardioversion treatment but patient did not convert from atrial fibrillation to sinus rhythm.The patient status was reported as stable.Based on the information received, the cause of the reported incident could not be conclusively determined.

• 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: 18029970
• MDR Text Key: 326856162
• Report Number: 2135147-2023-04750
• 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: 11/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 9-ACP2-010-031
• Device Lot Number: 8716754
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/31/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/19/2022
• 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
• Patient Age: 70 YR
• Patient Sex: Female