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

Model Number	9-ACP2-007-018
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cardiac Tamponade (2226); Pericardial Effusion (3271)
Date of Event	05/07/2025
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, an 18mm amplatzer amulet left atrial appendage occluder was successfully implanted in a patient using a 12f amplatzer amulet delivery sheath as part of a left atrial appendage closure procedure.The patient was administered 4000 ui of heparin and had a noted activated clotting time (act) level above 250 seconds.The patient was in atrial fibrillation at the time of procedure.The transeptal puncture was inferior-posterior.There was no difficulty experienced implanting the amulet.There was not multiple wire or delivery sheath exchanges.The patient remained hemodynamically stable throughout the procedure and there was no clinically significant delay in procedure reported.The patient was administered 2500 ui of protamine after procedure.It was noted 2 hours post-procedure, on echocardiography that the patient developed a 10mm circumferential pericardial effusion.The patient did develop cardiac tamponade.A pericardial effusion was not noted prior to procedure.With a syringe and a pigtail, blood sucked out.The patient was no taking an anticoagulant or antiplatelet medication prior to procedure.The patient was taking 250 mg of intravenous aspirin after procedure and administered clopidogrel 1 hour before the pericardial effusion was discovered.There was no allegation of malfunction against the abbott device or procedure.The patient was stable and alive at the time of report.No additional information was provided.
Additional Manufacturer Narrative
It was reported that two hours post successful amulet implant the patient developed a 10 mm circumferential pericardial effusion.The patient did develop cardiac tamponade.A returned device assessment could not be performed as the device remains implanted and 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.Request was made for additional procedural details surrounding the case (e.G., procedure imaging), however this information was not supplied by the site.Based on the information received, the cause of the reported patient effects of pericardial effusion and cardiac tamponade could not be conclusively determined.There were no complaints associated with any other devices from the lot.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 north; 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 north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 22118777
• Report Number: 2135147-2025-02890
• Device Sequence Number: 17908230
• Product Code: NGV
• UDI-Device Identifier: 00811806013466
• UDI-Public: (01)00811806013466(17)291231(10)10663794
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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): 06/13/2025

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-ACP2-007-018
• Device Catalogue Number: 9-ACP2-007-018
• Device Lot Number: 10663794
• 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: 05/07/2025
• Supplement Date Received by Manufacturer: 06/04/2025
• Initial Report FDA Received Date: 05/30/2025
• Supplement Report FDA Received Date: 06/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/07/2025
• 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 Sex: Unknown