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

Catalog Number	9-ACP2-010-034
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Codes	Shock (2072); Tachycardia (2095); Respiratory Insufficiency (4462)
Date of Event	10/09/2024
Type of Reportable Event	Death
Additional Manufacturer Narrative
It was reported that the device embolized next day of implant and the device was in the left ventricular outflow tract (lvot).The patient did not have any clinical signs or symptoms.Also reported that the patient emergently underwent heart surgery to remove the device.The patient was stable under observation in the intensive care unit and then developed high cardiac frequency tachycardia and low respiratory frequency.The patient expired away next day due to mixed respiratory shock and post-operative systemic inflammatory syndrome with multiple organ failure.Information from field indicated that the device sizing was determined via computed tomography scan and intracardiac echocardiogram, however the transseptal puncture was reportedly performed above the indicated location, which was why it was more difficult to place the device in the indicated position.Also indicated that all close signs were met, the device remained stable during the tug test, and the device was successfully implanted with no leakage around the device lobe.The device was not returned to abbott for analysis such that it is not possible to inspect the explanted device.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed, and the product met all specifications.Based on cine and medical review performed at abbott, only imaging provided was a single echo loop showing embolized device in lvot.The patient had a very large appendage; however, the measurements were not provided.The relationship of the death to device and/or patient is not possible to assess due to lack of images.The cause of reported patient effects respiratory insufficiency, tachycardia and shock could not be conclusively determined.The reported surgical intervention was a result of case-specific circumstances as the embolized device was surgically removed.Based on the information available from field indicated that the cause of the embolization was believed to be due to the laa being very big.However, this could not be conclusively determined.The reported shock, post-operative systemic inflammatory syndrome with multiple organ failure, and patient death appears to be a cascading effect.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.
Additional Manufacturer Narrative
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) 2024, a 34mm amplatzer amulet left atrial appendage occluder was chosen for implant utilizing a 14f amplatzer torqvue 45x45 delivery sheath.The device sizing was determined via computed tomography (ct) scan and intracardiac echocardiogram (ice).During the procedure, ultrasound and angiography were used.The left atrial pressure was 14mmhg.The procedure was reported to be very difficult.The transseptal puncture was reportedly performed above the indicated location, which was why it was more difficult to place the device in the indicated position.Nothing else unusual happened during the case per physician's report.All close signs were met, the device remained stable during the tug test, and the device was successfully implanted.The shape of the device was tire.There was no leakage around the device lobe.On (b)(6) 2024, it was found that the device had embolized and was lodging itself in the patient's cardiac regions.The device was in the left ventricular outflow tract (lvot).The patient did not have any clinical signs or symptoms.The patient emergently underwent heart surgery to remove the device.The patient was stable under observation in the intensive care unit.The patient then developed high cardiac frequency (tachycardia) and low respiratory frequency.On (b)(6) 2024, the patient passed away due to mixed respiratory shock and post-operative systemic inflammatory syndrome with multiple organ failure.The cause of the embolization was believed to be due to the laa being very big with dimensions close to the maximum suggested 31mm.

• 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: 20791157
• Report Number: 2135147-2024-05641
• Device Sequence Number: 12715072
• Product Code: NGV
• UDI-Device Identifier: 00811806013527
• UDI-Public: (01)00811806013527(17)251130(10)7762310
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: P200049
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/26/2024

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2025
• Device Catalogue Number: 9-ACP2-010-034
• Device Lot Number: 7762310
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/15/2024
• Supplement Date Received by Manufacturer: 12/13/2024
• Initial Report FDA Received Date: 11/27/2024
• Supplement Report FDA Received Date: 12/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/04/2020
• 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: 59 YR
• Patient Sex: Male