MAUDE Adverse Event Report: MEDTRONIC IRELAND ENDURANT II AORTIC STENT GRAFT; SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TR

Model Number	ETCF2828C49E
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	06/15/2021
Type of Reportable Event	Death
Additional Manufacturer Narrative
Other relevant device(s) are: product id: etlw1616c156e, serial/ lot #: (b)(4), ubd: 15-jan-2023, udi #: (b)(4); product id: etlw1616c156e, serial/ lot #: (b)(4), ubd: 15-jan-2023, udi #: (b)(4).If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
An endurant iis bifurcate stent graft was implanted in the patient for the endovascular treatment of a 80mm pre ruptured aaa during the index procedure it was reported the patient had an angled neck and the physician didn¿t want to cover the right renal so the device was landed slightly low.A type ia endoleak was observed after implant, endoanchors were placed but the endoleak persisted.An additional cuff was then implanted to resolve the leak.It was reported after the surgery, the patient suffered from abdominal compartment syndrome, continuous bleeding from lumbar arteries even after aneurysm was sealed and expired per the physician, the cause of the event was patient anatomy and that the patient passed away a few hours after the procedure was completed due to complications not related to device issues.No additional clinical sequalae were reported and the patient has expired.

• Brand Name: ENDURANT II AORTIC STENT GRAFT
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TR
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• MDR Report Key: 12121789
• Report Number: 9612164-2021-02627
• Device Sequence Number: 3966129
• Product Code: MIH
• UDI-Device Identifier: 00613994991447
• UDI-Public: 00613994991447
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P100021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/06/2021

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: 03/19/2022
• Device Model Number: ETCF2828C49E
• Device Catalogue Number: ETCF2828C49E
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/15/2021
• Initial Report FDA Received Date: 07/06/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death; Required Intervention