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

Model Number	ENLW1624C93E
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	Injury (2348)
Date of Event	04/09/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
An endurant stent graft system was implanted in a patient for the endovascular treatment of an unknown abdominal aortic disease.It was reported approximately 7 years post the index procedure a ct was performed which showed that the right iliac limb had pulled out of the iliac and was now in the aorta.Intervention was performed.During the intervention, the physician successfully got a wire through the endurant limb but it was decided that the limb was at too bad of an angle and the wire could not straighten.It was decided to place an aui device on the left side and occlude the right common iliac artery.A final angio was performed and there was no endoleak.As per the physician, the cause of the event was anatomy related with the right common iliac measuring 38mm and that at the time of implant, they may not have implanted far enough into the right common iliac.Due to expansion of the right common iliac, the endurant limb now had nothing to attach to.No additional clinical sequela were reported and the patient is fine.

• Brand Name: ENDURANT 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: 7521454
• Report Number: 2953200-2018-00725
• Device Sequence Number: 1696570
• Product Code: MIH
• UDI-Device Identifier: 00613994761897
• UDI-Public: 00613994761897
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: P100021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/17/2018

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: 08/04/2013
• Device Model Number: ENLW1624C93E
• Device Catalogue Number: ENLW1624C93E
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/23/2018
• Initial Report FDA Received Date: 05/17/2018
• 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: Required Intervention
• Patient Age: 75 YR