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

Model Number	ETLW1624C124E
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Codes	Death (1802); Ischemia (1942); Rupture (2208); Respiratory Failure (2484); Blood Loss (2597)
Date of Event	08/11/2018
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 stent graft system was implanted in a patient for the endovascular treatment of an abdominal aortic aneurysm of unknown size.It was reported that approx.2 years, 9 months post index procedure, the patient presented emergently with back pain.A ct scan identified a type ib endoleak in the left distal common iliac with rupture of the artery.The patient received treatment with the placement of coils in the left hypogastric and implantation of an endurant limb in the left common iliac extending into the left external iliac and the issue was resolved.Per the physician, the cause of the event is due to disease progression within the patient.It was reported that 2 days post intervention, the patient had hematochezia.Part of the descending and sigmoid colon was removed, it was reported that the procedure was tolerated well by the patient who was then moved to icu where they were ambulatory post surgery.One week post op the patient complained of shoulder pain and shortness of breath.The family decided on no further treatment and the patient expired the following day due to respiratory arrest.As per the physician, the cause of the subsequent events after the intervention were due to the implantation of the coils along with the patients low blood pressure and not due to the device.No additional clinical sequelae were reported.

• Brand Name: ENDURANT II ILIAC STENT GRAFT
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• MDR Report Key: 7846650
• Report Number: 2953200-2018-01265
• Device Sequence Number: 13735574
• Product Code: MIH
• UDI-Device Identifier: 00643169467507
• UDI-Public: 00643169467507
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P100021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/05/2018

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: 09/28/2017
• Device Model Number: ETLW1624C124E
• Device Catalogue Number: ETLW1624C124E
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/11/2018
• Initial Report FDA Received Date: 09/05/2018
• 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: 85 YR