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

Model Number	9-ACP2-007-022
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Angina (1710); Pericardial Effusion (3271); Pericarditis (4448)
Date of Event	07/03/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported on (b)(6) 2026 a 22 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.Prior to the procedure, a baseline trivial pericardial effusion presenting as transverse sinus fluid was noted.During the procedure, the activating clotting time (act) was above 287 seconds, and a total of heparin 15,000 units was administered.The heart rhythm was atrial fibrillation and the left atrial pressure was 16 mmhg.Transseptal was made at the inferior and mid-to-anterior location.The wire was positioned in the left upper pulmonary vein (lupv).The device was implanted.Protamine 50 mg was administered.The following day, the patient had chest pain.Transesophageal echocardiogram confirmed a small circumferential pericardial effusion.The physician believed the chest pain was from pericarditis due to the pericardial effusion.The patient was monitored and discharged with colchicine.The patient status was stable.The patient was taking aspirin and plavix at the time the pericardial effusion was dedicated.
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: 50056591
• Report Number: 2135147-2026-05156
• Device Sequence Number: 18771825
• Product Code: NGV
• UDI-Device Identifier: 00811806013480
• UDI-Public: (01)00811806013480(17)300930(10)11081266
• 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): 09/15/2026

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 9-ACP2-007-022
• Device Catalogue Number: 9-ACP2-007-022
• Device Lot Number: 11081266
• 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: 07/03/2026
• Supplement Date Received by Manufacturer: 09/09/2026
• Initial Report FDA Received Date: 07/28/2026
• Supplement Report FDA Received Date: 09/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/08/2025
• 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: Hospitalization; Required Intervention
• Patient Age: 80 YR
• Patient Sex: Female