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

Model Number	9-ACP2-010-031
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Stroke/CVA (1770); Obstruction/Occlusion (2422)
Date of Event	02/14/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on (b)(6) 2024, a 31mm amplatzer amulet left atrial appendage occluder was implanted in the patient.The patient discharged on plavix and aspirin (asa) for 6 months.At 6 months, taken off plavix, remained on asa.The 45 day transesophageal echocardiogram (tee) showed no leak, no device related thrombus (drt).On (b)(6) 2026, the patient presented to an outside hospital with stroke symptoms and confirmed to have acute left p2 occlusion.They decided to return patient to eliquis for 3 months, and re-image.The patient was reported stable.
Additional Manufacturer Narrative
The device remains implanted in patient.The device will not be returned for evaluation.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 31mm amplatzer amulet left atrial appendage occluder was implanted in the patient.The patient discharged on plavix and aspirin (asa) for 6 months.At 6 months, taken off plavix, remained on asa.The 45-day transesophageal echocardiogram (tee) showed no leak, no device related thrombus (drt).On (b)(6) 2026, the patient presented to an outside hospital with stroke symptoms and confirmed to have acute left p2 occlusion.They decided to return patient to eliquis for 3 months, and re-image.The patient was reported stable.
Additional Manufacturer Narrative
An event of an occlusion and stroke was reported.A returned device assessment could not be performed as the device remains implanted.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed, and the product met all defined manufacturing specifications.Additionally, the lot was reviewed for similar complaints, and there is no indication of a lot-specific product issue.Based on the available information, the cause for the reported occlusion and stroke could not be determined.A prolonged hospitalization and unexpected medical intervention were a result of case specific circumstances, as medication was administered.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: 24648390
• Report Number: 2135147-2026-01745
• Device Sequence Number: 18659481
• Product Code: NGV
• Combination Product (Y/N): N
• Initial Reporter State: WV
• 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): 05/07/2026

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?: No
• Operator of Device: Health Professional
• Device Model Number: 9-ACP2-010-031
• Device Catalogue Number: 9-ACP2-010-031
• Device Lot Number: 9056982
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/23/2026
• Supplement Date Received by Manufacturer: 05/05/2026
• Initial Report FDA Received Date: 03/20/2026
• Supplement Report FDA Received Date: 05/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/22/2023
• 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: Hospitalization; Disability; Required Intervention
• Patient Age: 83 YR
• Patient Sex: Female