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

Catalog Number	9-ACP2-010-034
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	Obstruction/Occlusion (2422)
Date of Event	10/23/2024
Type of Reportable Event	Death
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 (b)(6) 2024, a 34mm amplatzer amulet left atrial appendage occluder was chosen for implant using a 14f amplatzer torqvue 45x45 delivery sheath.The landing zone measurements were between 28 and 29mm.The sizing of the device was determined with measurements on echocardiography and angiography.During the procedure, echocardiography and angiography were used.The left atrial pressure was around 15mmhg.The device was deployed and partially recaptured once, and it had a tire compression shape.The device met the close criteria.A tension test was performed.There was a leak of less than 1mm in correspondence of pulmonary ridge.The device was implanted.On (b)(6) 2024, the patient showed discomfort.On echocardiogram, it was discovered that the device had completely embolized and was positioned on the mitral valve, causing a partial obstruction.The device was attempted to be retrieved via percutaneous snare but was unsuccessful.The patient was referred to cardiac surgery.The device was successfully explanted during surgery.After cardiac surgery, the patient passed away.The cause of the device embolization was unknown.
Additional Manufacturer Narrative
An event of device embolization, obstruction, and death 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.Additionally, a review of the complaint history identified no similar complaints reported from this lot.Based on the available information, the cause of the reported device embolization could not be conclusively determined.The cause of the partial obstruction was a result of the device embolizing.The cause of the reported death could not be conclusively determined.The reported surgical and unexpected medical intervention were result of case-specific circumstances as an attempt to snare the device was performed and the patient was sent for open-heart surgery to remove the embolized device and replace the mitral valve.There is no indication of a product quality issue with regards to manufacture, design, or labeling.
Event or Problem Description
Subsequent to the previously filed report, additional information was received: the device was successfully explanted during surgery.The mitral valve was replaced.After cardiac surgery, the patient passed away.The cause of the device embolization was unknown.

• 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: 20698602
• Report Number: 2135147-2024-05813
• Device Sequence Number: 20455331
• Product Code: NGV
• UDI-Device Identifier: 00811806013527
• UDI-Public: (01)00811806013527(17)270331(10)8450942
• 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): 01/14/2025

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: 8450942
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/23/2024
• Supplement Date Received by Manufacturer: 01/02/2025
• Initial Report FDA Received Date: 11/15/2024
• Supplement Report FDA Received Date: 01/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/28/2022
• 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: Death
• Patient Sex: Unknown