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

Model Number	9-ACP2-010-034
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Thrombosis/Thrombus (4440)
Date of Event	03/11/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on 11 march 2025, a 34mm amplatzer amulet occluder was selected for implant using a 14f amplatzer amulet delivery sheath.It was noted via transesophageal echocardiogram while inserting and maneuvering the occluder and delivery sheath, that a fibrous thrombus was detected in the distal part of the delivery sheath while in the left upper pulmonary vein.No threads were showing.The patient had been initially administered 5000 units of heparin for procedure and had an activated clotting time level of 227 seconds.An additional 4000 units were given, and after confirming the presence of a thrombus, a further 6000 units were administered.The 34mm amplatzer amulet occluder and 14f amplatzer amulet delivery sheath were removed.It's noted that the delivery sheath had been in the patient for 60 minutes.After removal it was noted that thrombus was seen also adhering to the occluder.A replacement 31mm amplatzer amulet occluder and 14f amplatzer amulet delivery sheath were used to complete the procedure.The patient does not have any hematologic disorders or systemic illness that could contribute to a hypercoagulability.There was no initial or prolonged hospitalization due to this event.The patient was stable at the time of report.
Additional Manufacturer Narrative
An event of patient device interaction problem associated with thrombus 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 for the reported patient device interaction problem with thrombus could not be conclusively determined.The reported unexpected medical intervention was a result of case-specific circumstances.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: 21773679
• Report Number: 2135147-2025-01730
• Device Sequence Number: 15519684
• Product Code: NGV
• UDI-Device Identifier: 00811806013527
• UDI-Public: (01)00811806013527(17)291031(10)10597003
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P200049
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/04/2025

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-ACP2-010-034
• Device Catalogue Number: 9-ACP2-010-034
• Device Lot Number: 10597003
• 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: 03/11/2025
• Initial Report FDA Received Date: 04/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/06/2024
• 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: 85 YR
• Patient Sex: Male
• Patient Weight: 59 KG