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

Model Number	9-ACP2-010-034
Medical Device Problem Codes	Migration or Expulsion of Device (1395); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Angina (1710); Cardiac Arrest (1762); Obstruction/Occlusion (2422)
Date of Event	03/27/2025
Type of Reportable Event	Death
Event or Problem Description
It was reported on (b)(6) 2025 a 28mm amplatzer amulet left atrial appendage occluder was selected for implant using a 14f amplatzer torqvue 45x45 delivery sheath to treat a left atrial appendage (laa).The patient's laa was measured under the following views: 24mm at 0 degrees, 20mm at 45 degrees, 22mm at 90 degrees, and 19mm at 135 degrees.The landing zone was measured at 27mm under angiography in right anterior oblique (rao).Transesophageal echocardiogram (tee) was used during the procedure.The patient's left atrial pressure was 12 mmhg.During the procedure the occluder was partially re-captured multiple times.The occluder was removed from the patient and re-sized to a new 34mm amplatzer amulet left atrial appendage occluder.The occluder was deployed.It was noted that there was a 30-40% mitral shoulder in the high transesophageal echocardiography (tee) angle and minimal separation between the lobe and the disc.Due to this close criteria were not completely met.There was visible compression on the lobe in the shape of a tire.The end screw offset and the occluder did not move or migrate during a tug test.The occluder was released from the delivery cable.A leak was observed that was less than 1mm.Within an hour post-procedure the patient presented with chest discomfort.It was discovered via chest x-ray that the occluder embolized to the left atrium and caused a partial blockage.The occluder was surgically explanted.Per the physician, the occluder embolized due to poor stability.The patient status was stable.
Additional Manufacturer Narrative
Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Additional Manufacturer Narrative
An event of device migration, an hour after the implant and residual shunt 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.From the imaging received it was noted that there was little compression and a leak on the mitral aspect of the device.The device did not meet all signs of close criteria.The device had a mitral shoulder and was not 2/3 past the level of the circumflex and very little separation noted on fluoro.The disc after a tension test was pushed in by the delivery cable which may have de-stabilized the device as well.Based on the information received, the cause of the reported events were due to procedural complications.However, this could not be conclusively determined.The reported unexpected surgical intervention was a result of case-specific circumstances as the device was surgically removed.There is no indication of a product quality issue with regards to manufacture, design, or labeling.
Event or Problem Description
It was reported on (b)(6) 2025 a 28mm amplatzer amulet left atrial appendage occluder was selected for implant using a 14f amplatzer torqvue 45x45 delivery sheath to treat a left atrial appendage (laa).The patient's laa was measured under the following views: 24mm at 0 degrees, 20mm at 45 degrees, 22mm at 90 degrees, and 19mm at 135 degrees.The landing zone was measured at 27mm under angiography in right anterior oblique (rao).Transesophageal echocardiogram (tee) was used during the procedure.The patient's left atrial pressure was 12 mmhg.During the procedure the occluder was partially re-captured multiple times.The occluder was removed from the patient and re-sized to a new 34mm amplatzer amulet left atrial appendage occluder.The occluder was deployed.It was noted that there was a 30-40% mitral shoulder in the high transesophageal echocardiography (tee) angle and minimal separation between the lobe and the disc.Due to this close criteria were not completely met.There was visible compression on the lobe in the shape of a tire.The end screw offset and the occluder did not move or migrate during a tug test.The occluder was released from the delivery cable.A leak was observed that was less than 1mm.Within an hour post-procedure the patient presented with chest discomfort.It was discovered via chest x-ray that the occluder embolized to the left atrium and caused a partial blockage.The occluder was surgically explanted.Per the physician, the occluder embolized due to poor stability.The patient status was hospitalization.On (b)(6) 2025 the patient went into asystole.The patient had a do not resuscitate (dnr) order, therefore no intervention was performed.The patient passed away.
Additional Manufacturer Narrative
An event of device migration, an hour after the implant, residual shunt and patient death after two months of implant was reported.Information from the field indicated that close criteria were not completely met.Also noted that embolized to the left atrium and caused a partial blockage.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 device embolization is most likely related to device oversizing and not achieving a stable device position.And the cause of the reported death could not be conclusively determined.The reported unexpected surgical intervention was a result of case-specific circumstances as the device was surgically removed.There is no indication of a product quality issue with regards to manufacture, design, or labeling.From medical review: the death occurring more than 2 months post-implant it is unlikely to be related to the implant procedure or amulet occluder since the device was explanted surgically.

• 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: 21875034
• Report Number: 2135147-2025-02096
• Device Sequence Number: 18108981
• Product Code: NGV
• UDI-Device Identifier: 00811806013527
• UDI-Public: (01)00811806013527(17)290831(10)10541678
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/20/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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: 10541678
• 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: 03/27/2025
• Supplement Date Received by Manufacturer: 05/28/2025; 05/28/2025
• Initial Report FDA Received Date: 04/21/2025
• Supplement Report FDA Received Date: 06/02/2025; 06/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/01/2024
• 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; Death
• Patient Sex: Male