MAUDE Adverse Event Report: Abbott Medical Amplatzer Amulet; Cardiac Plug

Model Number	9-ACP2-007-016
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Fatigue (1849); Cardiac Tamponade (2226); Pericardial Effusion (3271)
Date of Event	07/05/2026
Type of Reportable Event	Death
Event or Problem Description
It was reported on (b)(6) 2026 a mm amplatzer amulet left atrial appendage occluder was selected for implant using a 12f amplatzer amulet delivery sheath for a left atrial appendage (laa) closure.The patient was taking an oral anticoagulant prior to the procedure.The laa was characterized to be small with a long distance noted from the ostium to the neck with substantial depth.The imaging modalities used were 2d (tee) and 3d multiplanar reconstruction (mpr).The landing zone measurements were 13.2 mm at 0 degrees, 12.4 mm at 45 degrees, 12.2 mm at 90 degrees, and 11.7 mm at 135 degrees.The ostium diameter was 13.2 mm on 2d tee.A considerable height, measured about 12.7 mm, was observed between the landing zone and the pulmonary vein (pv) ridge.During the procedure, the activating clotting time (act) was 170 second and and heparin was administered.The heart rhythm was normal sinus and the left atrial pressure was 12 mmhg.Transseptal puncture was made at the inferior mid location.The wire was positioned in the left upper pulmonary vein.Deployment was performed more gradually than usual, progressing from the ball to triangle configuration given the laa anatomy.Tee confirmed positioning of the device.In the 45-degree view, the disc was observed to be in contact with the pv ridge, however due to the elevated anatomy, the superior margin was not completely reached.The distance between the device and the pulmonary artery was 4mm.Close criteria were satisfied and a tension test was performed for 20 seconds, then observed for movement again as the disc relaxed.No movement was observed.Close criteria were re-evaluated and confirmed.The device was implanted.The patient was discharged home.While at home, the patient was reported to have complaints of malaise and fatigue.The following morning, the patient was found deceased.Postmortem examination confirmed the presence of a pericardial effusion.The physician suspects cardiac failure secondary to cardiac tamponade as the cause of death.However, this was not confirmed.The physician believed the 16 mm amulet (10735251) was related to the pericardial effusion.
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 on (b)(6) 2026 a 16 mm amplatzer amulet left atrial appendage occluder was selected for implant using a 12f amplatzer amulet delivery sheath for a left atrial appendage (laa) closure.The patient was taking an oral anticoagulant prior to the procedure.The laa was characterized to be small with a long distance noted from the ostium to the neck with substantial depth.The imaging modalities used were 2d (tee) and 3d multiplanar reconstruction (mpr).The landing zone measurements were 13.2 mm at 0 degrees, 12.4 mm at 45 degrees, 12.2 mm at 90 degrees, and 11.7 mm at 135 degrees.The ostium diameter was 13.2 mm on 2d tee.A considerable height, measured about 12.7 mm, was observed between the landing zone and the pulmonary vein (pv) ridge.During the procedure, the activating clotting time (act) was 170 second and and heparin was administered.The heart rhythm was normal sinus and the left atrial pressure was 12 mmhg.Transseptal puncture was made at the inferior mid location.The wire was positioned in the left upper pulmonary vein.Deployment was performed more gradually than usual, progressing from the ball to triangle configuration given the laa anatomy.Tee confirmed positioning of the device.In the 45-degree view, the disc was observed to be in contact with the pv ridge, however due to the elevated anatomy, the superior margin was not completely reached.The distance between the device and the pulmonary artery was 4mm.Close criteria were satisfied and a tension test was performed for 20 seconds, then observed for movement again as the disc relaxed.No movement was observed.Close criteria were re-evaluated and confirmed.The device was implanted.The patient was discharged home.While at home, the patient was reported to have complaints of malaise and fatigue.The following morning, the patient was found deceased.Postmortem examination confirmed the presence of a pericardial effusion.The physician suspects cardiac failure secondary to cardiac tamponade as the cause of death.However, this was not confirmed.The physician believed the 16 mm amulet (10735251) was related to the pericardial effusion.
Additional Manufacturer Narrative
An event of pericardial effusion that led to cardiac tamponade two days post procedure was reported.A returned device assessment could not be performed as the device remains implanted and was not returned for analysis.Additionally, the imaging was reviewed by an abbott representative: stating "no imaging was provided for review.A 73-year-old male with a history of thromboembolic disease, recurrent cerebral infarctions, and atrial fibrillation underwent implantation of a 16 mm amplatzer amulet device on (b)(6) 2026.Pre-procedural imaging demonstrated a small left atrial appendage (laa) with adequate depth and a narrow landing zone.The device size was reported to be appropriate for the patient's anatomy and consistent with the manufacturer's sizing recommendations.The procedure was reported as uncomplicated, with no difficulties during transseptal puncture, device deployment, positioning, or release.No pericardial effusion or other procedural complications were reported.The patient was discharged following the procedure and died at home the following day.According to the report, the patient complained of malaise and fatigue after returning home.Postmortem examination identified pericardial effusion, and cardiac failure secondary to suspected cardiac tamponade was reported as the presumed cause of death.The operator stated that device oversizing, over-compression, and procedural factors were considered unlikely contributors to the event.The distance between the laa and pulmonary artery was reported as approximately 4 mm, which was considered anatomically sufficient.It was stated that a relationship between the device and the pericardial effusion could not be completely excluded.We are unable to receive more information about the patients comborbidities (ef, heart failure, arrhythmias, coronary artery disease, coronary artery disease, other device therapy), medication (especially anticoagulation management pre/intra/post procedure), additional diagnostic findings (e.G.Pre-hospital discharge ultasounds) and potential autopsy results due to japanese data privacy laws.Based on the available information, the procedure was reported to be uncomplicated, and the implanted device size was consistent with the patient's anatomy and manufacturer recommendations.The patient subsequently developed a pericardial effusion resulting in suspected cardiac tamponade and death.Due to the absence of procedural imaging, detailed postmortem findings, and definitive evidence identifying the source of the pericardial effusion, the nature of the relationship between device performance and tamponade cannot be established.The available information does not identify a device malfunction.Should additional information become available, this assessment may be revised." the device history record was reviewed to ensure that each manufacturing and inspection operation was performed, and the product met all specifications.There were no complaints associated with any other devices from the lot.Based on the information and imaging; the exact cause of the reported event could not be conclusively determined.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 ; +1(651)756-5400
• MDR Report Key: 50087331
• Report Number: 2135147-2026-05193
• Device Sequence Number: 9816367
• Product Code: NGV
• UDI-Device Identifier: 00811806013459
• UDI-Public: (01)00811806013459(17)300131(10)10735251
• 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: 2026
• 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): 10/02/2026

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-ACP2-007-016
• Device Catalogue Number: 9-ACP2-007-016
• Device Lot Number: 10735251
• 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: 07/08/2026
• Supplement Date Received by Manufacturer: 09/10/2026
• Initial Report FDA Received Date: 07/30/2026
• Supplement Report FDA Received Date: 10/02/2026
• 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: Death
• Patient Age: 73 YR
• Patient Sex: Male