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); Gastrointestinal Hemorrhage (4476)
Date of Event	01/14/2026
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 on (b)(6) 2025, a 18mm amplatzer amulet was implanted using a 12f amulet delivery sheath.The transseptal puncture location was described as inferior/mid.The patient was described as stable before, during, and after the procedure, and no baseline pericardial effusion was observed.The minimum measured distance to the pulmonary artery was 2.92 mm.During the procedure, the act was recorded as 368 seconds, and the left atrial pressure was not measured.A pigtail wire was used to access the appendage, and the sheath exchange was performed within the left atrial appendage (laa).One partial recapture of the device was conducted to improve positioning.A tension test was performed, and the close criteria were reported to be met prior to final deployment.Heparin was administered during the procedure, and protamine or another reversal agent was given during or after the procedure.No pericardial effusion was noted at discharge.The patient was discharged the same day on dual antiplatelet therapy (dapt) with a plan for routine follow-up.Approximately one month later, the patient presented to the emergency department with a gastrointestinal bleed and was subsequently found to have a significant circumferential pericardial effusion, which was confirmed to be associated with cardiac tamponade.The patient was reported to be on antiplatelet therapy (apt) at the time the effusion was detected.Pericardiocentesis was performed, and the patient stabilized and, was discharged with no further medical intervention required at that time.The treating physician believes the amulet device contributed to the development of the pericardial effusion but does not consider a pulmonary artery injury to be the cause.
Event or Problem Description
It was reported that on (b)(6) 2025, a 18mm amplatzer amulet was implanted using a 12f amulet delivery sheath.The transseptal puncture location was described as inferior/mid.The patient was described as stable before, during, and after the procedure, and no baseline pericardial effusion was observed.The minimum measured distance to the pulmonary artery was 2.92 mm.During the procedure, the act was recorded as 368 seconds, and the left atrial pressure was not measured.A pigtail wire was used to access the appendage, and the sheath exchange was performed within the left atrial appendage (laa).One partial recapture of the device was conducted to improve positioning.A tension test was performed, and the close criteria were reported to be met prior to final deployment.Heparin was administered during the procedure, and protamine or another reversal agent was given during or after the procedure.No pericardial effusion was noted at discharge.The patient was discharged the same day on dual antiplatelet therapy (dapt) with a plan for routine follow-up.Approximately one month later, the patient presented to the emergency department with a gastrointestinal bleed and was subsequently found to have a significant circumferential pericardial effusion, which was confirmed to be associated with cardiac tamponade.The patient was reported to be on antiplatelet therapy (apt) at the time the effusion was detected.Pericardiocentesis was performed, and the patient stabilized and, was discharged with no further medical intervention required at that time.The treating physician believes the amulet device contributed to the development of the pericardial effusion but does not consider a pulmonary artery injury to be the cause.
Additional Manufacturer Narrative
An event of an implant related tissue damage was reported with gastrointestinal hemorrhage, pericardial effusion, and cardiac tamponade.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.There were no complaints associated with any other devices from the lot.Based on the available information and cine review, the cause for the reported implant related tissue damage could not be determined.The reported gastrointestinal hemorrhage, pericardial effusion, and cardiac tamponade are likely cascading effects from the event.A prolonged hospitalization and unexpected medical intervention were a result of case-specific circumstances, as a pericardiocentesis were 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: 24283890
• Report Number: 2135147-2026-00734
• Device Sequence Number: 8318597
• Product Code: NGV
• UDI-Device Identifier: 00811806013466
• UDI-Public: (01)00811806013466(17)300531(10)10903376
• 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): 03/17/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• 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: 10903376
• 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: 01/14/2026
• Supplement Date Received by Manufacturer: 03/11/2026
• Initial Report FDA Received Date: 02/06/2026
• Supplement Report FDA Received Date: 03/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/10/2025
• 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 Age: 82 YR
• Patient Sex: Female