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

Model Number	ETBF2313C124E
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Ischemia (1942); Pain (1994); Embolism/Embolus (4438)
Date of Event	03/08/2021
Type of Reportable Event	Death
Additional Manufacturer Narrative
Concomitant medical products: other relevant device(s) are: product id: etlw1613c93e, serial/lot #: (b)(4) , ubd: 16-feb-2022, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
An endurant ii stent graft system was implanted in the patient for the endovascular treatment of an aortic ulcer.It was stated that the patient was throwing thrombus before the initial procedure.Patient underwent evar to prevent thrombus from the infrarenal aorta from continuing to break off and cause ischemia in her lower extremities.It was reported that the patient was discharged on the next day post index procedure, however, the patient returned to the hospital on the next day post discharge with abdominal pain.It was stated that the patient was admitted and taken to surgery for an ischemic right colon.Patient died approximately 1 weeks post index procedure.As per the physician, cause of the event was bowel ischemia.The physician stated that thrombus went into the sma causing the right colon ischemia.The physician stated that wire manipulation could have lead to more thrombus going into the sma.The physician does not believe that the device lead to the complication due to it being the right colon no additional clinical sequelae were reported and the patient expired.

• Brand Name: ENDURANT II BIFURCATED 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: 11886274
• Report Number: 9612164-2021-02070
• Device Sequence Number: 19741244
• Product Code: MIH
• UDI-Device Identifier: 00613994991164
• UDI-Public: 00613994991164
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 05/26/2021

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 05/19/2022
• Device Model Number: ETBF2313C124E
• Device Catalogue Number: ETBF2313C124E
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/07/2021
• Initial Report FDA Received Date: 05/26/2021
• 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
• Patient Age: 70 YR