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	Hemorrhage/Blood Loss/Bleeding (1888); Cardiac Tamponade (2226); Pericardial Effusion (3271)
Date of Event	02/26/2026
Type of Reportable Event	Serious Injury
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 (b)(6) 2026, a 22mm amplatzer amulet was chosen for implant using an unknown delivery system.No pericardial effusion was noted prior to the procedure.Transseptal puncture was performed at an inferior posterior location.At the time of the procedure, the patient was in sinus rhythm, with a left atrial pressure of 12 mmhg.Heparin was administered at a dose of 100 e/kg, achieving an activated clotting time (act) greater than 250 seconds.The left atrial appendage (laa) closure proceeded smoothly, with no reported difficulty or multiple manipulations during device implantation.The 22 mm amplatzer amulet device was positioned in a windsock-type laa anatomy in a semi-sandwich configuration.Several hours after the laa closure, the patient developed symptoms consistent with cardiac tamponade.Further evaluation revealed a circumferential pericardial effusion, with the largest dimension measuring approximately 1.5 cm, which was noted in the region of the left atrial appendage.Stabilization measures were initiated, including placement of a pericardial drain.Initially, there was significant blood loss through the drain, which subsequently decreased to approximately 200 ml per day.T was reported that the user believes the pericardial effusion was caused by the abbott 22 mm amplatzer amulet device.
Event or Problem Description
It was reported that (b)(6) 2026, a 22mm amplatzer amulet was chosen for implant using an unknown delivery system.No pericardial effusion was noted prior to the procedure.Transseptal puncture was performed at an inferior posterior location.At the time of the procedure, the patient was in sinus rhythm, with a left atrial pressure of 12 mmhg.Heparin was administered at a dose of 100 e/kg, achieving an activated clotting time (act) greater than 250 seconds.The left atrial appendage (laa) closure proceeded smoothly, with no reported difficulty or multiple manipulations during device implantation.The 22 mm amplatzer amulet device was positioned in a windsock-type laa anatomy in a semi-sandwich configuration.Several hours after the laa closure, the patient developed symptoms consistent with cardiac tamponade.Further evaluation revealed a circumferential pericardial effusion, with the largest dimension measuring approximately 1.5 cm, which was noted in the region of the left atrial appendage.Stabilization measures were initiated, including placement of a pericardial drain.Initially, there was significant blood loss through the drain, which subsequently decreased to approximately 200 ml per day.T was reported that the user believes the pericardial effusion was caused by the abbott 22 mm amplatzer amulet device.
Additional Manufacturer Narrative
An event of an implant related tissue damage, hemorrhage, pericardial effusion, and cardiac tamponade were reported.A returned device assessment could not be performed as the device remains implanted.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed, and the product met all defined manufacturing 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 for the reported related tissue damage could not be determined.It is possible that procedural circumstances contributed to the event, however this cannot be determined.The reported pericardial effusion and cardiac tamponade are likely cascading effects from the event.An unexpected medical intervention was a result of case specific circumstances, as a pericardiocentesis was performed.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: 24720079
• Report Number: 2135147-2026-01990
• Device Sequence Number: 6087780
• Product Code: NGV
• 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: 2026
• 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): 06/22/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Operator of Device: Health Professional
• Device Model Number: 9-ACP2-007-022
• Device Catalogue Number: 9-ACP2-007-022
• Device Lot Number: 10767429
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/02/2026
• Supplement Date Received by Manufacturer: 06/13/2026
• Initial Report FDA Received Date: 03/30/2026
• Supplement Report FDA Received Date: 06/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/12/2025
• 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: 69 YR
• Patient Sex: Female