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

Catalog Number	9-ACP2-010-034
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Cardiac Tamponade (2226); Pericardial Effusion (3271)
Date of Event	12/09/2024
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
It was reported that a 34mm amplatzer amulet left atrial appendage occluder was selected for implant on (b)(6) 2024 using a 14f amplatzer torqvue 45x45 delivery sheath.The patient was in sinus rhythm.Transseptal access was inferior-posterior.The patient's activated clotting time (act) level was 310 seconds.The patient's left atrial pressure was 13mmhg.8000 units of heparin were administered.During the procedure the first deployment attempt was unsatisfactory and the decision was made to partially re-capture the occluder.It was noted there was difficulty to engage the central lobe due to there being 3 lobes.During the re-capture a circumferential cardiac tamponade occurred.The decision was made to release the occluder in the left atrial appendage (laa).A continuous drainage of the pericardial effusion was done until the occluder was released.The cardiac tamponade stopped on its own.The patient was transferred to the intensive care unit (icu).The user believed the occluder caused the pericardial effusion.The patient status was stable.
Additional Manufacturer Narrative
An event of patient-device incompatibility (pericardial effusion, cardiac tamponade) was reported.A returned device assessment could not be performed as 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 the information received, the cause of the reported pericardial effusion lead to cardiac tamponade could not be conclusively determined.The reported unexpected medical interventions was resulted of case-specific circumstances as pericardiocentesis was performed on the patient.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: 21069737
• Report Number: 2135147-2025-00069
• Device Sequence Number: 8409569
• Product Code: NGV
• UDI-Device Identifier: 00811806013527
• UDI-Public: (01)00811806013527(17)280731(10)9197313
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: P200049
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 03/05/2025

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 9-ACP2-010-034
• Device Lot Number: 9197313
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/09/2024
• Supplement Date Received by Manufacturer: 02/26/2025
• Initial Report FDA Received Date: 01/03/2025
• Supplement Report FDA Received Date: 03/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/17/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 14F AMPLATZER TORQVUE 45X45 DS[DS-TV45X45-14F-080]
• Outcome Attributed to Adverse Event: Required Intervention; Life Threatening; Hospitalization
• Patient Sex: Unknown