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

Model Number	9-ACP2-010-031
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/23/2026
Type of Reportable Event	Serious Injury
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
Clinical information: (b)(4) - advance laa, patient site id: (b)(6).It was reported that on - (b)(6) 2024, a 28mm amplatzer amulet left atrial appendage occluder was chosen for a left atrial appendage (laa) closure procedure using a amulet¿ steerable delivery sheath.The laa depth was 24mm and the shape of the appendage was chicken wing.The left atrial pressure was 11 mmhg and atrial rhythm recorded at start of procedure was sinus rhythm.The activated clotting levels were 234,255s and heparin was given.The 28mm amulet was not implanted due to incompatible with anatomy.A new 31mm amplatzer amulet left atrial appendage occluder was successfully implanted.On (b)(6) 2026, the patient had a cardioversion due to atrial fibrillation (af) and transesophageal echocardiogram showed a 3mm peri device leak.There was no thrombus was noted in the amulet.The patient was initiated with 5mg apixaban twice daily.The patient was reported stable.
Additional Manufacturer Narrative
An event of a patient device interaction problem associated with residual shunt 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.There were no complaints associated with any other devices from the lot.Based on the information received, a root cause of the reported patient device interaction problem with residual shunt could not be conclusively determined.The reported medical intervention was a result of case specific circumstances as medication was given.There is no indication of a product quality issue with respect to labeling, design, or manufacturing of the device.
Event or Problem Description
Clinical information: (b)(6).It was reported that on (b)(6) 2024, a 28mm amplatzer amulet left atrial appendage occluder was chosen for a left atrial appendage (laa) closure procedure using a amulet¿ steerable delivery sheath.The laa depth was 24mm and the shape of the appendage was chicken wing.The left atrial pressure was 11 mmhg and atrial rhythm recorded at start of procedure was sinus rhythm.The activated clotting levels were 234,255s and heparin was given.The 28mm amulet was not implanted due to incompatible with anatomy.A new 31mm amplatzer amulet left atrial appendage occluder was successfully implanted.On (b)(6) 2026, the patient had a cardioversion due to atrial fibrillation (af) and transesophageal echocardiogram showed a 3mm peri device leak.There was no thrombus was noted in the amulet.The patient was initiated with 5mg apixaban twice daily.The patient was reported stable.

• 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: 24681741
• Report Number: 2135147-2026-01871
• Device Sequence Number: 13204219
• Product Code: NGV
• UDI-Device Identifier: 00811806013510
• UDI-Public: (01)00811806013510(17)271231(10)8846342
• Combination Product (Y/N): N
• Initial Reporter State: NE
• 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: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/07/2026

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?: No
• Operator of Device: Health Professional
• Device Model Number: 9-ACP2-010-031
• Device Catalogue Number: 9-ACP2-010-031
• Device Lot Number: 8846342
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/27/2026
• Supplement Date Received by Manufacturer: 04/01/2026
• Initial Report FDA Received Date: 03/24/2026
• Supplement Report FDA Received Date: 04/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/18/2023
• 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: Required Intervention
• Patient Age: 81 YR
• Patient Sex: Male
• Patient Weight: 98 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White