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

Catalog Number	9-ACP2-007-016
Medical Device Problem Codes	Migration or Expulsion of Device (1395); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/02/2024
Type of Reportable Event	Malfunction
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 16mm amplatzer amulet left atrial appendage occluder was implanted.The landing zone measurements at 0 degrees, 45 degrees, 90 degrees, and 135 degrees were 12mm, 12mm, 11mm, and 17mm, respectively.Intracardiac echocardiography (ice) measured the landing zone at 14mm.Measurements were taken as well as taking pectinate muscle into consideration.Transesophageal echocardiography (tee) and ice were used during the procedure.The left atrial pressure was 9mmhg, and fluid was provided.Then, the left atrial pressure was measured at 12mmhg.The device had a tire shape compression.The close criteria were satisfied, and a tension test was performed.There was no difficulty implanting the device.There was no leak detected around the lobe of the device once implanted.At a 45 day follow up, a tee was performed, which showed that the device may have migrated from its initial position, causing a leak.The patient did not have any clinical signs or symptoms.A computed tomography (ct) scan was performed.The device was determined to be stable, so the patient was kept on oral anticoagulation.The patient status was reported as stable.
Additional Manufacturer Narrative
It was reported that a tee at a 45 day follow up showed the amulet device may have migrated from its initial position, causing a leak.Also reported that the device was determined to be stable, so the patient was kept on oral anticoagulation.Information from field indicated that the device had a tire shape compression and the close criteria were satisfied, and a tension test was performed.There was no reported difficulty implanting the device and no leak detected around the lobe of the device when implanted.The device remains implanted and will not return to abbott 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 cine review performed at abbott, leak did appear to be suspect but it was difficult to determine with certainty if intra or peri device leak.The quality of ct made it difficult to access the device.Without previous echo images it is unable to confirm if device migrated.Based on the information received, the cause of the reported leak could not be conclusively determined.There were no complaints associated with any other devices from the lot.Based on the information received, 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: 20368359
• Report Number: 2135147-2024-04873
• Device Sequence Number: 19769628
• Product Code: NGV
• UDI-Device Identifier: 00811806013459
• UDI-Public: (01)00811806013459(17)280131(10)8883101
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/31/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 9-ACP2-007-016
• Device Lot Number: 8883101
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/09/2024
• Supplement Date Received by Manufacturer: 10/25/2024
• Initial Report FDA Received Date: 10/04/2024
• Supplement Report FDA Received Date: 10/31/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/08/2023
• 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
• Patient Age: 76 YR
• Patient Sex: Female