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

Model Number	9-ACP2-007-016
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported on (b)(6) 2025, a 16mm amplatzer amulet left atrial appendage occluder was selected for implant.The patient's landing zone measurements under the following views were: 10.9mm at 0 degrees, 11.3mm at 45 degrees, 11.1mm at 90 degrees, and 12.4mm at 135 degrees.Transesophageal echocardiogram and angiography were used to determine device sizing and were also used interprocedurally.During the procedure the occluder was repositioned multiple times.Close criteria were met.A tension test was performed.The patient's left atrial pressure was above 12 mmhg.500ml of heparin was administered.The occluder had a barrel-shaped compression.The occluder was implanted.On (b)(6) 2025 during a post-procedure transthoracic echocardiogram (tte) the position of the occluder could not be confirmed.An x-ray confirmed the occluder embolized to the aorta.On (b)(6) 2025, the occluder was snared and removed from the patient.The patient did not present with any clinical signs or symptoms.The patient status was stable.
Additional Manufacturer Narrative
The device is not returning for evaluation.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Additional Manufacturer Narrative
It was reported that the amulet occluder embolized to the aorta four days after implant.Information from the field indicated that during the procedure the occluder was repositioned multiple times.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.Based on the information received, the cause of the reported embolization could not be conclusively determined.It is possible that the procedural condition (difficulty positioning the device) may have contributed to the reported embolization, however this could not be confirmed.The reported unexpected medical intervention was due to case-specific circumstance as the occluder was snared and removed from the patient.There were no complaints associated with any other devices from the lot.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 MN 1897- 4050; CS 1897-4050
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 22071940
• Report Number: 2135147-2025-02696
• Device Sequence Number: 9301506
• Product Code: NGV
• UDI-Device Identifier: 00811806013459
• UDI-Public: (01)00811806013459(17)300131(10)10735253
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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): 07/03/2025

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-ACP2-007-016
• Device Catalogue Number: 9-ACP2-007-016
• Device Lot Number: 10735253
• 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: 04/29/2025
• Supplement Date Received by Manufacturer: 06/26/2025
• Initial Report FDA Received Date: 05/22/2025
• Supplement Report FDA Received Date: 07/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/20/2025
• 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; Hospitalization
• Patient Sex: Unknown