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

Model Number	9-ACP2-007-018
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/03/2025
Type of Reportable Event	Malfunction
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
It was reported that on (b)(6) 2025, a 18mm amplatzer amulet left atrial appendage occluder was chosen for implant using a 14f amplatzer amulet delivery sheath.While considering slightly smaller pre-measured values and concerns about the distance to the pulmonary artery (pa) they decided to use a 18mm amulet.The landing zone measurements were 18.1mm (0°), 18.5mm (45°), 13.3mm (90°), 16mm (135°); 3d: 17.9 × 16.2mm.The patient¿s heart rhythm during the procedure was sinus rhythm, left atrial pressure was 13 mmhg and standard fluid administration was performed, but exact volume is unknown.The image modality used in the procedure was transesophageal echocardiogram (tee) and angiography (angio).During the first disc deployment, the lobe was not fixed and moved proximally, so partial recapture and redeployment were performed.The shape of the device at the time of implantation was tire-shape.At the time of device release, the close criteria were met, a tension test was performed and ee confirmed device compression was in a elliptical shape.There was no peri-device leak (pdl) was noted.At the 45-day follow-up, a coronary computed tomography angiography (ccta) was performed, which confirmed the presence of the device in the left atrial appendage (laa), but device migration was observed.A tee was also conducted, which similarly confirmed the migration and no leak was observed.The patient remained in sinus rhythm both during the procedure and at outpatient follow-up visits.The intraoperative imaging showed a space on the anterior side, and part of the anchor was not contacting the lobe.That may have led to insufficient fixation and subsequent migration.No additional treatment was deemed necessary, the patient was discharged home without hospitalization.The patient was reported stable.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
An event of device migration observed at 45 day follow-up 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.Based on the information received, the cause of the reported migration is consistent with insufficient fixation of the device.However, this cannot be confirmed.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 1897- 4050; CS 1897-4050
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 22898783
• Report Number: 2135147-2025-04809
• Device Sequence Number: 12985861
• Product Code: NGV
• UDI-Device Identifier: 00811806013466
• UDI-Public: (01)00811806013466(17)291031(10)10605365
• 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
• 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): 10/23/2025

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 9-ACP2-007-018
• Device Catalogue Number: 9-ACP2-007-018
• Device Lot Number: 10605365
• 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: 07/31/2025
• Supplement Date Received by Manufacturer: 10/07/2025
• Initial Report FDA Received Date: 08/26/2025
• Supplement Report FDA Received Date: 10/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/12/2024
• 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
• Patient Age: 84 YR
• Patient Sex: Male
• Patient Weight: 54 KG