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

Catalog Number	9-ACP2-010-034
Medical Device Problem Codes	Migration or Expulsion of Device (1395); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/27/2024
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 on 27 december 2024, a 31mm amplatzer amulet left atrial appendage occluder was chosen for implant using a 14f amplatzer torqvue 45x45 delivery sheath.The sizing of the device was determined by intracardiac echocardiography (ice).A re-sizing of the device was performed form 31mm to 34mm and four non-abbott devices were attempted.Finally a 34mm was selected.During procedure, the left atrial pressure was above 12mmhg, close criteria was satisfied and tension test was performed twice.The 34 amulet was successfully implanted with the same delivery system and device compression was in a tire shape.After the procedure, when the patient was in the recovery area, an embolization of the amulet device was noted in transthoracic echocardiogram (tte).The device was stayed in the left atrium.The device got retrieved via percutaneous retrieval through the groin from the left atrium.The patient was reported stable.
Additional Manufacturer Narrative
An event of migration or expulsion of device (device embolization) and improper or incorrect procedure or method 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.The provided imaging was reviewed by an abbott clinical engineering manager.Based on the information received, a cause for the reported device embolization could not be determined.The reported improper or incorrect procedure or method appears to be related to user did not used a new 34mm amulet.The reported unexpected medical intervention was a result of case-specific circumstances.There is no indication of a product quality issue with regards to manufacture, design, or labeling.

• 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: 21218650
• Report Number: 2135147-2025-00371
• Device Sequence Number: 8741052
• Product Code: NGV
• UDI-Device Identifier: 00811806013527
• UDI-Public: (01)00811806013527(17)280229(10)8951789
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P200049
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/11/2025

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: 8951789
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/30/2024
• Supplement Date Received by Manufacturer: 02/28/2025
• Initial Report FDA Received Date: 01/23/2025
• Supplement Report FDA Received Date: 03/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/20/2023
• 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
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention
• Patient Age: 89 YR
• Patient Sex: Male