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

Model Number	9-ACP2-010-034
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	Obstruction/Occlusion (2422)
Date of Event	07/25/2025
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
It was reported on (b)(6) 2025 a 34mm amplatzer amulet left atrial appendage occluder was selected for implant using a 14f amulet delivery sheath.The patient had a windsock-shaped left atrial appendage (laa) morphology, characterized by distal narrowing.The landing zone was measured under the following views: 27mm at 0 degrees, 27mm at 45 degrees, and 28mm at 90 degrees.Echocardiogram and angiography were used during the procedure.The patient's left atrial pressure was 7mmhg.During the procedure the occluder was re-sheathed twice.The final placement was proximal and close criteria were met, however there was some concern about the proximal position and underfilling of the patient.The occluder had barrel-shaped compression.The lobe of the occluder was positioned approximately 2-3mm behind the circumflex artery (cx).Upon release of the occluder, the occluder embolized to the mitral valve and caused a partial blockage.The patient was transferred to cardiac surgery for explant of the occluder.The patient status was stable.Per the physician, the device embolization was due to poor imaging quality.
Additional Manufacturer Narrative
An event of device migration, right after the implant release 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 complaints reported from this lot.Per the physician, the device embolization was due to poor imaging quality.Abbott requested.Although requested, information regarding the imaging of the procedure and procedural notes were not provided.The cause of the reported migration could not be conclusively determined.The reported surgical intervention was a result of case-specific circumstances as the migrated device was removed.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.
Event or Problem Description
It was reported on (b)(6) 2025 a 34mm amplatzer amulet left atrial appendage occluder was selected for implant using a 14f amulet delivery sheath.The patient had a windsock-shaped left atrial appendage (laa) morphology, characterized by distal narrowing.The landing zone was measured under the following views: 27mm at 0 degrees, 27mm at 45 degrees, and 28mm at 90 degrees.Echocardiogram and angiography were used during the procedure.The patient's left atrial pressure was 7mmhg.During the procedure the occluder was re-sheathed twice.The final placement was proximal and close criteria were met, however there was some concern about the proximal position and underfilling of the patient.The occluder had barrel-shaped compression.The lobe of the occluder was positioned approximately 2-3mm behind the circumflex artery (cx).Upon release of the occluder, the occluder embolized to the mitral valve and caused a partial blockage.The patient was transferred to cardiac surgery for explant of the occluder.The patient status was stable.Per the physician, the device embolization was due to poor imaging quality.

• 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: 22828603
• Report Number: 2135147-2025-04597
• Device Sequence Number: 19977843
• Product Code: NGV
• UDI-Device Identifier: 00811806013527
• UDI-Public: (01)00811806013527(17)271031(10)8742236
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• 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): 10/31/2025

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: 8742236
• 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: 07/25/2025
• Supplement Date Received by Manufacturer: 10/24/2025
• Initial Report FDA Received Date: 08/18/2025
• Supplement Report FDA Received Date: 10/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/03/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 14F AMULET DS [DS-TV45X45-14F-080, LOT: 8742236].
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female