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 Codes	Cardiac Tamponade (2226); Pericardial Effusion (3271)
Date of Event	04/24/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a 16mm amplatzer amulet left atrial appendage occluder was selected for implant on (b)(6) 2024 using a 12f amplatzer torqvue 45x45 delivery sheath.Is was noted that the left atrial appendage (laa) had a reverse chicken wing shape.The patient was in sinus rhythm during the procedure.Transseptal puncture was inferior posterior.The patient's activating clotting time (act) was less than 300 sec.8000 units of heparin were administered.The patient's left atrial pressure was greater than 12mmhg.No pericardial was noted prior to the procedure.During the procedure no re-captures were required.There were no difficulties noted with deploying the device.The device was implanted.4 hours post-implant a pericardial effusion was detected which led to a cardiac tamponade.The cardiac tamponade surrounded the heart and was 2mm from the subcostal plane.Pericardiocentesis was performed.Upon further review, it was observed that the pulmonary artery was very close to the distal part of the lobe, which was believed to be the cause of the cardiac tamponade.The patient status was stable.
Additional Manufacturer Narrative
Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Additional Manufacturer Narrative
An event of pericardial effusion that led to cardiac tamponade 4-hours post procedure was reported.A pericardiocentesis was performed to resolve the event.A returned device assessment could not be performed as the device remains implanted and was not returned for analysis.Information from field indicated that during the procedure no re-captures were required and there were no difficulties noted when deploying the device.Based on the information received, the cause of the reported incident could not be conclusively determined.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.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: 19356513
• Report Number: 2135147-2024-02289
• Device Sequence Number: 20436834
• Product Code: NGV
• UDI-Device Identifier: 00811806013459
• UDI-Public: (01)00811806013459(17)250930(10)7705610
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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): 07/15/2024

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 Expiration Date: 09/30/2025
• Device Catalogue Number: 9-ACP2-007-016
• Device Lot Number: 7705610
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/26/2024
• Supplement Date Received by Manufacturer: 06/27/2024
• Initial Report FDA Received Date: 05/20/2024
• Supplement Report FDA Received Date: 07/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/19/2020
• 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 Age: 78 YR
• Patient Sex: Male
• Patient Weight: 78 KG