MAUDE Adverse Event Report: Abbott Medical Amplatzer Amulet; Cardiac Plug

Model Number	9-ACP2-010-025
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Arrhythmia (1721); Pericardial Effusion (3271)
Date of Event	06/22/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported on (b)(6) 2026 a 25 mm amplatzer amulet left atrial appendage occluder was selected for implant using a 14f amplatzer amulet delivery sheath for a left atrial appendage (laa) closure.The patient was taking plavix, eliquis, and aspirin prior to the procedure.Trace pericardial effusion was noted anteriorly prior to the procedure.The max landing zone was 21.8 mm.The patient was noted to have cactus-shaped morphology.During the procedure, the activating clotting time (act) was 268 seconds, and heparin 6000 units was administered.The heart rhythm was normal sinus.The left atrial pressure was 21 mmhg.Transseptal puncture was made at the inferior-mid location.The wire was placed in the left upper pulmonary vein (lupv).One partial recaptured was performed.The device was implanted.The patient was observed overnight and discharged the following morning following a normal transthoracic echocardiogram (tee).On an unknown date, the patient presented to the hospital with circumferential, moderate to large, pericardial effusion.The patient had atrial fibrillation with rapid ventricular rate (rvr) related to the pericardial effusion.A pericardiocentesis was performed and 400 cc of blood was drained.The patient status was stable.The physician noted that the patient continued taking both plavix and eliquis in error, despite being advised to only continue plavix and aspirin.
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.

• 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 ; +1(651)756-5400
• MDR Report Key: 50039224
• Report Number: 2135147-2026-05141
• Device Sequence Number: 21459397
• Product Code: NGV
• UDI-Device Identifier: 00811806013497
• UDI-Public: (01)00811806013497(17)300930(10)11074000
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: P200049
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• 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): 09/14/2026

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-ACP2-010-025
• Device Catalogue Number: 9-ACP2-010-025
• Device Lot Number: 11074000
• 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: 07/02/2026
• Supplement Date Received by Manufacturer: 09/07/2026
• Initial Report FDA Received Date: 07/27/2026
• Supplement Report FDA Received Date: 09/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/03/2025
• 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; Hospitalization
• Patient Sex: Unknown