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

Model Number	ETUF2814C102E
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cardiac Arrest (1762)
Date of Event	01/10/2022
Type of Reportable Event	Death
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
An endurant ii aui stent graft was implanted during the emergent endovascular treatment of a ruptured abdominal aortic aneurysm.  it was reported after the patient was transferred to the or and before the stent was implanted the patient¿s status changed; the patient became unresponsive without pulses.It was determined the patient aaa had ruptured and cpr was started.After a discussion between the physician and the anesthesiologist it was determined the patient needed his aorta controlled.The physician cut down over the common femoral artery and placed a balloon in the patient¿s thoracic aorta however the patient did not recover from the occlusion and cpr was continued.The physician then elected to place an aui in the patient¿s infrarenal aorta and extended to the external iliac artery excluding the aneurysm.Unfortunately, cpr was stopped, and the patient was unable to be resituated, after a consultation between the physician and the anesthesiologist the procedure and all resituating activities were completed.The patient expired shorty after.As per the physician the cause of death was cardiac related surrounding an abdominal aortic aneurysm rupture.Due to the patients fragile status and having multiple comorbidities the patient was unable to be resuscitated post aneurysm rupture.No additional clinical sequalae was provided and the patient has expired.

• Brand Name: ENDURANT II AUI STENT GRAFT
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TR
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 13236234
• Report Number: 9612164-2022-00171
• Device Sequence Number: 4555191
• Product Code: MIH
• UDI-Device Identifier: 00643169232594
• UDI-Public: 00643169232594
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P100021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/12/2022

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 Expiration Date: 01/14/2023
• Device Model Number: ETUF2814C102E
• Device Catalogue Number: ETUF2814C102E
• 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: 01/10/2022
• Initial Report FDA Received Date: 01/12/2022
• Date Device Manufactured: 01/14/2021
• 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: 80 YR
• Patient Sex: Male