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

Catalog Number	9-ACP2-007-016
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pericardial Effusion (3271)
Date of Event	10/12/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
(b)(4).It was reported that on (b)(6) 2023, a 16mm amplatzer amulet left atrial appendage (laa) occluder was chosen for implantation utilizing a 12f amplatzer torqvue 45x45 delivery system.Patient presented in sinus rhythm with left atrial pressure of 9mm hg.Heparin was administered as anticoagulant, maintaining a minimum 257 activated clotting time.The occluder was implanted successfully without recaptures or multiple manipulations.There were no wires placed in the laa or pulmonary veins.On (b)(6) 2023, at the discharge transesophageal echocardiogram (tee) a 4mm width pericardial effusion was observed.The effusion was considered trivial by the physician and no hemodynamic compromise was observed.No treatment was performed and the patient was discharged.
Additional Manufacturer Narrative
An event of pericardial effusion was reported.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.Based on available information, the reported physical packaging damage appears to be related to shipping, handling, and/or storage.Based on all available information, a cause for the reported pericardial effusion could not be conclusively determined.
Event or Problem Description
(b)(6).It was reported that on (b)(6) 2023, a 16mm amplatzer amulet left atrial appendage (laa) occluder was chosen for implantation utilizing a 12f amplatzer torqvue 45x45 delivery system.Patient presented in sinus rhythm with left atrial pressure of 9mm hg.Heparin was administered as anticoagulant, maintaining a minimum 257 activated clotting time.The occluder was implanted successfully without recaptures or multiple manipulations.There were no wires placed in the laa or pulmonary veins.On (b)(6) 2023, at the discharge transesophageal echocardiogram (tee) a 4mm width pericardial effusion was observed.The effusion was considered trivial by the physician and no hemodynamic compromise was observed.No treatment was performed and the patient was discharged.

• 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: 21388359
• Report Number: 2135147-2025-00731
• Device Sequence Number: 15602254
• Product Code: NGV
• UDI-Device Identifier: 00811806013459
• UDI-Public: (01)00811806013459(17)271031(10)8753137
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: P200049
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/13/2025

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 Catalogue Number: 9-ACP2-007-016
• Device Lot Number: 8753137
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/20/2025
• Supplement Date Received by Manufacturer: 03/06/2025
• Initial Report FDA Received Date: 02/14/2025
• Supplement Report FDA Received Date: 03/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/09/2022
• 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: Other
• Patient Age: 70 YR
• Patient Sex: Female
• Patient Weight: 43 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White