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

Model Number	9-ACP2-007-020
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	Dyspnea (1816)
Date of Event	08/24/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It is unknown if the device is returning for analysis.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that on (b)(6) 2025, a 20mm amplatzer amulet left atrial appendage occluder was chosen for implant using a 14f amplatzer amulet delivery sheath.The sizing of the device was determined by transthoracic echocardiogram (tte) and angiography.The left atrial pressure was above 12mmhg and 500 ml of fluids were given.The amulet was successfully implanted.The close criteria was not completely satisfied, as the device was too proximal (c) and the orientation was not perfect (o).The tension test was performed and device compression was in a tire shape.After the procedure, during night the patient complained of shortness of breath and was subsequently placed in the intensive care unit with suspected pulmonary edema.The patient remained stable.Two days after implantation, the on-call physician who had also implanted the occluder performed another tee and observed that the occluder had embolized into the left ventricle.The physician mentioned the cause of embolization was potentially undersized and too proximal device.The patient subsequently underwent surgery and reported stable.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
An event of device embolization into the left ventricle, after the device implant was reported.The reviewer noted: ¿3 videos were provided.2 were of sizing of the laa (1 fluoro and 1 echo).The third video shows the embolized device via tee imaging.No imaging of the final implanted occluder prior to embolization was provided.¿ 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 complaints reported from this lot.Based on available information and without the device to analyze, the cause of the reported event could not be conclusively determined.The reported surgical intervention was a result of case-specific circumstances as the embolized device was surgically removed.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: 23265377
• Report Number: 2135147-2025-05745
• Device Sequence Number: 10146316
• Product Code: NGV
• UDI-Device Identifier: 00811806013473
• UDI-Public: (01)00811806013473(17)291031(10)10627855
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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,Followup
• Report Date (Section B): 11/05/2025

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-ACP2-007-020
• Device Catalogue Number: 9-ACP2-007-020
• Device Lot Number: 10627855
• 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: 09/15/2025
• Supplement Date Received by Manufacturer: 10/22/2025
• Initial Report FDA Received Date: 10/10/2025
• Supplement Report FDA Received Date: 11/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/27/2024
• 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 Sex: Unknown