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

Catalog Number	9-ACP2-010-034
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Stroke/CVA (1770); Fatigue (1849); Numbness (2415); Syncope/Fainting (4411); Thrombosis/Thrombus (4440)
Date of Event	06/20/2024
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
Clinical information: crd_1056 - advance laa, patient site id: (b)(6).It was reported that on 05 june 2024, a 34mm amplatzer amulet left atrial appendage (laa) occluder (9-acp2-010-034) utilizing a 14f amplatzer torqvue delivery system (9-tv45x45-14f-080).On 20 june 2024, the patient returned to hospital with lower extremity weakness.Thrombus was observed on the device.
Event or Problem Description
Subsequent to the initial report, the following additional information was received: it was reported that on (b)(6) 2024, a 34mm amplatzer amulet left atrial appendage (laa) occluder (lot: 8916305) utilizing a 14f amplatzer torqvue delivery system (lot: 10003440).Minimum activated clotting time during procedure was 348 seconds.After implantation patient was prescribed asa and plavix.On (b)(6) 2024, the patient returned to hospital with lower extremity weakness.The patient felt lightheaded and felt a tingling sensation on head.A globular thrombus was observed on the device via transesophageal echocardiogram.Ischemic stroke was also diagnosed via mri.Eliquis anti-coagulant was given along with apixaban and lisinopril.On (b)(6) 2024, the patient's international normalized ratio was 1.08.Stroke assessment placed patient at modified rankin scale grade 3.It was reported to be probable that the amulet device caused the stroke.National institutes of health stroke scale score of 1 on (b)(6) 2024 for sensory-left facial numbness.The patient was discharged home on 26 june 2024 with no permanent injury or disability.
Additional Manufacturer Narrative
An event of thrombus and arrhythmia noted after 15 days of implant was reported.It was field indicated that the patient did not have any hematological disorders predisposing to abnormal thrombus formation.It was also reported that heparinized during the procedure with an activated clotting time of 348 seconds, more than recommended in instructions for use.A returned device assessment could not be performed as the device remains implanted and 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.Based on cine review performed at abbott, "smoke observed at la/laa interface.Drt clearly visible in run 57 of the tee.The device seems to be appropriately sized.Although the disc is below the pvr, it appears to be appropriately positioned because the wide ostium and long pvr prevented the disc from landing on the pvr.No doppler images around the device are included in the study.Therefore, the reviewer was unable to confirm presence or lack of presence of pdl.Based on the information received, the cause of the reported incident could not be conclusively determined.The medical intervention was performed as the medication was administered.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.Thrombus is a possible outcome of the procedure per the amplatzer amulet instructions for use.H6: health effect - clinical code: 1770, 4411, 2415.H6: health effect - impact code: 4641, 4607.

• 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: 20066445
• Report Number: 2135147-2024-04172
• Device Sequence Number: 18308492
• Product Code: NGV
• UDI-Device Identifier: 00811806013527
• UDI-Public: (01)00811806013527(17)280131(10)8916305
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: P200049
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/21/2024

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: 8916305
• 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: 08/01/2024
• Supplement Date Received by Manufacturer: 11/13/2024
• Initial Report FDA Received Date: 08/26/2024
• Supplement Report FDA Received Date: 11/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/28/2023
• 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: Other; Hospitalization; Required Intervention
• Patient Sex: Unknown