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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/07/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on (b)(6) 2024, a 34mm amplatzer amulet left atrial appendage (laa) occluder was chosen for implant using a 14f amplatzer torqvue 45x45 delivery sheath.Sizing of the device was determined by transesophageal echocardiography (tee) and fluoroscopic measurements.The landing zone measurements were as follows: 0 degrees: 27.5mm; 45 degrees: 21mm; 90 degrees: 26.3mm; 135 degrees: 28mm.Tee was used during procedure.The left atrial pressure was above 12mmhg.Venous access was obtained, and the interatrial septum was crossed through an existing patent foramen ovale (pfo).The transseptal sheath was exchanged for a 14f amplatzer torqvue 45x45 delivery sheath, a pigtail was introduced, and the sheath was positioned in the laa.The device was prepped and advanced into the laa.The device was deployed and partially recaptured twice due to difficult anatomy.A tension test was performed.The device was compressed with distal end screw offset.The device appeared to meet all close criteria and released from the delivery cable.After release, the device shifted.Approximately 2 minutes after the device was released, it embolized into the left atrium (la).Transseptal access was regained using a sl1 sheath and a 16f dryseal sheath replaced the shorter venous sheath used during deployment.An agilis sheath was advanced through the 16f sheath, and a myocardial biopsy forceps device was used to attempt to retrieve the amulet, but the attempts were unsuccessful.A second transseptal puncture was performed with the sl1 sheath and brk needle.That sheath was exchanged for the agilis sheath, which was removed from the 16f sheath and re-prepped.A gooseneck snare was used through the agilis sheath, and the amulet was emergently snared.It was brought through the interatrial septum and into the left femoral vein where access was attained.A vascular cut down was performed to remove the device from the vein in the groin.The patient was stable throughout the entire procedure and left the room in stable condition.The implanter believed that the device was not fully seated in the mitral aspect of the laa, which led to the device embolization.
Additional Manufacturer Narrative
Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Additional Manufacturer Narrative
It was reported that the amulet device shifted upon release from delivery cable and embolized into left atrium.The embolized device did not cause a partial or complete obstruction/blockage of blood flow.Also reported that the implanter believed that the device was not fully seated in the mitral aspect of the laa, which led to the device embolization.Information from the field indicated that the sizing of the device was determined by transesophageal echocardiography (tee) and fluoroscopic measurements.Field also indicated that the device was deployed and partially recaptured twice due to difficult anatomy.Reportedly, the device appeared to meet all close criteria and released from the delivery cable.The device was not returned to abbott for analysis such that it is not possible to inspect the explanted device.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed, and the product met all specifications.It is possible that the difficult anatomy may have led to device not being fully seated in mitral aspect of laa which resulted in device embolization upon release; however, this could not be conclusively determined.The embolized device was attempted to be retrieved using sheath but the attempts were unsuccessful.A gooseneck snare was used, and the amulet was emergently snared.Based on the information received, the cause of the reported incident could not be conclusively determined.The reported surgical intervention was a result of case-specific circumstances as a vascular cut down was performed to remove the device from the vein in the groin.The patient was reported to be stable throughout the entire procedure and left the room in stable condition.There were no complaints associated with any other devices from the lot.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: 20589769
• Report Number: 2135147-2024-05526
• Device Sequence Number: 18342149
• Product Code: NGV
• UDI-Device Identifier: 00811806013527
• UDI-Public: (01)00811806013527(17)270831(10)8657056
• 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): 12/03/2024

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 9-ACP2-010-034
• Device Lot Number: 8657056
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/07/2024
• Supplement Date Received by Manufacturer: 11/21/2024
• Initial Report FDA Received Date: 11/01/2024
• Supplement Report FDA Received Date: 12/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/09/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: AMPLATZER TORQVUE 45X45 DS, 9-TV45X45-14F-080.
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention
• Patient Sex: Male