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 Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/22/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on 18 october 2024, a 34mm amplatzer amulet left atrial appendage occluder (lot: 8951561) was chosen for implantation utilizing an unknown delivery system.At 45 day follow-up echocardiogram, a residual leak was observed.The appendage was measured at 29mm during the index procedure, but at the follow-up it was 36mm.Patient is stable and was administered oral anticoagulant.
Additional Manufacturer Narrative
Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Additional Manufacturer Narrative
An event of patient device interaction problem associated with residual shunt was reported.A returned device assessment could not be performed as the device 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.Additionally, a review of the complaint history identified no similar incidents reported from this lot.Based on the information received, a root cause of the reported incident could not be conclusively determined.The reported unexpected medical intervention was a resulted of case-specific circumstances.There is no indication of a product quality issue with regards to manufacture, design, or labeling.
Event or Problem Description
It was reported that on (b)(6) 2024, a 34mm amplatzer amulet left atrial appendage occluder (lot: 8951561) was chosen for implantation utilizing a 14f amplatzer torqvue delivery system.At the 45 day follow-up echocardiogram, a residual leak was observed.The appendage was measured at 29mm during the index procedure, but at the follow-up it was 36mm.Patient is stable and was administered oral anticoagulant.No further intervention was performed.

• 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: 20939202
• Report Number: 2135147-2024-06399
• Device Sequence Number: 20883461
• Product Code: NGV
• UDI-Device Identifier: 00811806013527
• UDI-Public: (01)00811806013527(17)280229(10)8951561
• 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): 02/18/2025

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: 8951561
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/22/2024
• Supplement Date Received by Manufacturer: 02/11/2025
• Initial Report FDA Received Date: 12/16/2024
• Supplement Report FDA Received Date: 02/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/20/2023
• 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: 74 YR
• Patient Sex: Male