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

Model Number	9-ACP2-007-018
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Cardiac Tamponade (2226); Pericardial Effusion (3271)
Date of Event	06/24/2025
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 that on (b)(6) 2025, an 18mm amplatzer amulet was selected for implant using a 12f amplatzer amulet delivery sheath.No pericardial effusion was observed prior to procedure.The transseptal puncture was mid antero posterior and inferior.The amulet was implanted upon the first attempt and with "minimum of manipulations inside the left appendage." close criteria was met and stability test was performed and passed.Post-implant transesophageal echocardiogram (tee) was performed and negative for pericardial effusion.Approximately one hour post-procedure, "the patient collapsed" while in the intensive care unit (icu).Transthoracic echocardiogram (tte) was performed, which showed a "massive" localized posterior large pericardial effusion; cardiac tamponade was confirmed present.The cause of the effusion was thought to be either due to the transseptal puncture or to amulet manipulation; "no clear answer" was provided.The pericardial space was drained.Despite this and resuscitation, the patient passed away.The cause of death was reported as "massive tamponade.".
Additional Manufacturer Narrative
It was reported that pericardial effusion, cardiac tamponade and patient death were reported.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.No information was received to indicate that the patient¿s monitored activated clotting time was abnormal.Information from field indicated that the amulet was implanted with minimum manipulations.Abbott requested for procedure imaging to review, this was not provided by the site.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 cause of the reported pericardial effusion due to the transseptal puncture or to amulet manipulation.However, this cannot be confirmed.The cause of cardiac tamponade and death are maybe cascade events of effusion.The reported unexpected medical intervention was a result of case-specific circumstances as pericardiocentesis was performed.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.From medical review: without analysis of procedural imaging it is not possible to assess the location of the transseptal puncture or the manipulation of the amulet device within the left atrial appendage.As a result, the mechanism of causation of the pericardial effusion cannot be established.
Event or Problem Description
N/a.

• 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: 22533668
• Report Number: 2135147-2025-03892
• Device Sequence Number: 15429620
• Product Code: NGV
• UDI-Device Identifier: 00811806013466
• UDI-Public: (01)00811806013466(17)300131(10)10733198
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/18/2025

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: 10733198
• 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: 06/24/2025
• Supplement Date Received by Manufacturer: 08/13/2025
• Initial Report FDA Received Date: 07/17/2025
• Supplement Report FDA Received Date: 08/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/19/2025
• 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; Required Intervention
• Patient Sex: Unknown