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

Model Number	9-ACP2-007-018
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Angina (1710); Cardiac Arrest (1762); Non specific EKG/ECG Changes (1817); Low Blood Pressure/ Hypotension (1914); Cardiac Tamponade (2226); Pericardial Effusion (3271); Movement Disorder (4412)
Date of Event	05/17/2025
Type of Reportable Event	Death
Additional Manufacturer Narrative
The device remains implanted in patient.The device will not be returned for evaluation.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported on (b)(6) 2025 an 18mm amplatzer amulet left atrial appendage occluder was selected for implant using a 14f amplatzer torqvue 45x45 delivery sheath.The patient had a pre-existing trace effusion at the start of the procedure.Transseptal puncture was inferior and mid.The patient had a hypercontractile appendage.The patient's left atrial pressure was 13 mmhg.Close criteria were met and the occluder was implanted.The trivial effusion was unchanged.On (b)(6) 2025 the patient returned to the hospital with dizziness and chest pain and became hypotensive.A surface echocardiogram revealed a moderate, circumferential pericardial effusion with a right ventricle chamber collapse.The effusion developed into a cardiac tamponade.The patient decompensated with st changes and became hemodynamically unstable.The patient went into cardiac arrest and cardiopulmonary resuscitation (cpr) was performed.A pericardiocentesis was performed while the patient was coding and 150cc of liquid was removed.The patient passed away on (b)(6) 2025.The cause of death was the pericardial effusion.The user believed the pericardial effusion was due to the occluder.
Additional Manufacturer Narrative
An event of dizziness, chest pain, hypotension, circumferential pericardial effusion and cardiac tamponade were reported two days post amulet device implant.While in the hospital the patient decompensated further and went into cardiac arrest requiring cardiopulmonary resuscitation (cpr).A pericardiocentesis was performed while the patient was coding.However, the patient expired and the cause of death was reported as pericardial effusion.The device remained implanted and will not return to abbott 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 cine review performed at abbott, the final amulet device position appeared to be deep into the laa.A deep amulet implant into the laa may have increased the risk for developing a pericardial effusion.Based on medical review, the patient death appears to be related to post-procedure bleeding into pericardial space with development of cardiac tamponade.The cause for the bleeding could not be determined.It is possible that bleeding may be result of micro-perforation of the laa and/or injury to the pulmonary artery.However, this could not be confirmed.A pericardial effusion is a known potential adverse event following laao.The reported patient effects of angina, movement disorder, pericardial effusion, cardiac tamponade, hypotension, cardiac arrest and death appears to be a cascading effect.The reported hospitalization and unexpected medical intervention were result of case-specific circumstance as pericardiocentesis was performed for perforation and resuscitation was required due to cardiac arrest.There were no complaints associated with any other devices from the lot.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.

• Brand Name: AMPLATZER AMULET
• Common Device Name: 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: 22186222
• Report Number: 2135147-2025-03093
• Device Sequence Number: 18243186
• Product Code: NGV
• UDI-Device Identifier: 00811806013466
• UDI-Public: (01)00811806013466(17)290930(10)10565243
• Combination Product (Y/N): N
• Initial Reporter State: WV
• Initial Reporter Country: US
• PMA/510(K) Number: P200049
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/06/2025

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?: No
• Operator of Device: Health Professional
• Device Model Number: 9-ACP2-007-018
• Device Catalogue Number: 9-ACP2-007-018
• Device Lot Number: 10565243
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/19/2025
• Supplement Date Received by Manufacturer: 07/28/2025
• Initial Report FDA Received Date: 06/11/2025
• Supplement Report FDA Received Date: 08/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/16/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Age: 84 YR
• Patient Sex: Male