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

Model Number	9-ACP2-007-022
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pericardial Effusion (3271)
Date of Event	01/04/2026
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 22mm amplatzer amulet was chosen for implant using a 12f amulet delivery system.The procedure was described as uncomplicated.Pre-operative planning included 3mensio and feops assessments and no pericardial effusion was noted prior to the procedure.A routine transseptal puncture was performed at an inferior/superior location.During the procedure, the patient remained in af/sr, and the activated clotting time (act) was maintained above 300 seconds throughout.The patient had been taking oral anticoagulation and aspirin prior to the procedure, and this regimen continued at the time the later pericardial effusion was detected.Heparin was administered intra-procedurally, with 5,000 units initially followed by an additional 2,000 units.No protamine or other reversal agents were used.The wire position was maintained in the left upper pulmonary vein, and there were no multiple wire or delivery sheath exchanges.The left atrial pressure at the time of the procedure was 11 mmhg.A wire was not placed in the left atrial appendage at any point.The first device was partially recaptured once and fully recaptured once, then removed due to missizing.A second 22 mm amulet device was implanted and deployed successfully on the first attempt.Approximately two weeks later, the patient developed a pericardial effusion.As the implanting physician was on leave, the patient was managed by physicians in the coronary care unit.On (b)(6) 2026, a cardiac surgeon performed a pericardial tap, during which 800 ml of serous fluid was drained.The physicians did not conclude that cardiac tamponade was present.It was reported that the physician believed the patient¿s underlying medical condition predisposed them to the development of the effusion, and that the event was not related to the abbott device.The patient was subsequently discharged from the hospital on (b)(6) 2026.
Additional Manufacturer Narrative
An event of pericardial effusion post procedure was reported.A device return evaluation could not be performed because 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.Based on all available information, the reported pericardial effusion could not be conclusively determined.Information from the field indicated that patient comorbidities may have contributed to the event; however, this cannot be confirmed.The reported unexpected medical intervention, and hospitalization were the result of case-specific circumstances, as pericardiocentesis was performed for the pericardial effusion and the patient required prolonged hospitalization.There is no indication of a product quality issue related to the device¿s labeling, design, or manufacturing.
Event or Problem Description
It was reported that on (b)(6) 2025, a 22mm amplatzer amulet was chosen for implant using a 12f amulet delivery system.The procedure was described as uncomplicated.Pre-operative planning included 3mensio and feops assessments and no pericardial effusion was noted prior to the procedure.A routine transseptal puncture was performed at an inferior/superior location.During the procedure, the patient remained in af/sr, and the activated clotting time (act) was maintained above 300 seconds throughout.The patient had been taking oral anticoagulation and aspirin prior to the procedure, and this regimen continued at the time the later pericardial effusion was detected.Heparin was administered intra-procedurally, with (b)(4) units initially followed by an additional (b)(4) units.No protamine or other reversal agents were used.The wire position was maintained in the left upper pulmonary vein, and there were no multiple wire or delivery sheath exchanges.The left atrial pressure at the time of the procedure was 11 mmhg.A wire was not placed in the left atrial appendage at any point.The first device was partially recaptured once and fully recaptured once, then removed due to missizing.A second 22 mm amulet device was implanted and deployed successfully on the first attempt.Approximately two weeks later, the patient developed a pericardial effusion.As the implanting physician was on leave, the patient was managed by physicians in the coronary care unit.On (b)(6) 2026, a cardiac surgeon performed a pericardial tap, during which 800 ml of serous fluid was drained.The physicians did not conclude that cardiac tamponade was present.It was reported that the physician believed the patient¿s underlying medical condition predisposed them to the development of the effusion, and that the event was not related to the abbott device.The patient was subsequently discharged from the hospital on (b)(6) 2026.

• 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: 24298684
• Report Number: 2135147-2026-00749
• Device Sequence Number: 10165402
• Product Code: NGV
• UDI-Device Identifier: 00811806013480
• UDI-Public: (01)00811806013480(17)291130(10)10640696
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/29/2026

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-ACP2-007-022
• Device Catalogue Number: 9-ACP2-007-022
• Device Lot Number: 10640696
• 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: 01/15/2026
• Supplement Date Received by Manufacturer: 04/20/2026
• Initial Report FDA Received Date: 02/09/2026
• Supplement Report FDA Received Date: 04/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/09/2024
• 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
• Patient Weight: 70 KG