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

Model Number	9-ACP2-007-020
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Atrial Fibrillation (1729); Bradycardia (1751); Cardiac Tamponade (2226); Pericardial Effusion (3271)
Date of Event	09/19/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on (b)(6) 2025, a 20mm amplatzer amulet left atrial appendage occluder was chosen for a left atrial appendage (laa) closure procedure using a 12f amplatzer torqvue 45x45 delivery sheath.The amulet was successfully implanted.Zero recaptures were performed, tension test performed for stability and the device met all close criteria.The patient was reported stable at all times pre, during and post procedure.The patient was sent to post anesthesia care unit (pacu) for post anesthesia recovery.The patient went into atrial fibrillation with rapid ventricular response (rvr)and was given esmolol.The patient became bradycardic and chest compressions started.A pericardial effusion noted on bedside echocardiogram, blood and platelets given and attempted to drain the effusion.It was unable to fully drain pericardium due to blood clotting off, only 40ml removed.The patient taken to cardiovascular surgery (cv) surgery to further drain clot.The patient was reported stable post surgery.
Additional Manufacturer Narrative
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, a 20mm amplatzer amulet left atrial appendage occluder was chosen for a left atrial appendage (laa) closure procedure using a 12f amplatzer torqvue 45x45 delivery sheath.During the procedure, the activated clotting time (act) levels were above 250s and 9000 units of heparin was administered.The left atrial pressure at time of procedure was 12mmhg.The amulet was successfully implanted.Zero recaptures were performed, tension test performed for stability and the device met all close criteria.The patient was reported stable at all times pre, during and post procedure.The patient was sent to post anesthesia care unit (pacu) for post anesthesia recovery.The patient went into atrial fibrillation with rapid ventricular response (rvr)and was given esmolol.The patient became bradycardic and chest compressions started.A pericardial effusion noted on bedside echocardiogram, blood and platelets given and attempted to drain the effusion.A cardiac tamponade was also present.It was unable to fully drain pericardium due to blood clotting off, only 40ml removed.The patient taken to cardiovascular surgery (cv) surgery to further drain clot.The user believe secondary to user believe secondary cardiopulmonary resuscitation (cpr) caused the effusion.The patient was reported stable post surgery.
Additional Manufacturer Narrative
An event of atrial fibrillation, bradycardia, 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.Additionally, the lot was reviewed for similar complaints, and there is no indication of a lot-specific product issue.Based on the available information, the cause of the reported incidents could not be conclusively determined.The reported surgical and unexpected medical intervention were results of case-specific circumstances as the medication was administered, pericardiocentesis was performed, and subsequently a drainage of the fluid was done surgically.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.Codes added: health effect - clinical code: 2226.

• 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: 23297043
• Report Number: 2135147-2025-05852
• Device Sequence Number: 10193269
• Product Code: NGV
• UDI-Device Identifier: 00811806013473
• UDI-Public: (01)00811806013473(17)300228(10)10783839
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 11/21/2025

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-ACP2-007-020
• Device Catalogue Number: 9-ACP2-007-020
• Device Lot Number: 10783839
• 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: 09/19/2025
• Supplement Date Received by Manufacturer: 11/13/2025
• Initial Report FDA Received Date: 10/15/2025
• Supplement Report FDA Received Date: 11/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/22/2025
• 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: Required Intervention
• Patient Age: 60 YR
• Patient Sex: Female