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

Model Number	ENLW1624C124E
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	Rupture (2208)
Date of Event	05/09/2019
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 ii stent graft system was implanted in a patient for the endovascular treatment of an unknown diameter abdominal aortic aneurysm.It was reported that the patient presented emergently approximately 7 years post implant with a left iliac rupture.It was noted on a ct that the left iliac limb had migrated to the level of the aortic bifurcation and that the left iliac had expanded.An intervention was carried out; a balloon was placed inside the body of the endurant bifurcate from the right, to occlude blood flow.The physician then coiled the left hypogastric and implanted 2 endurant limbs from the stent graft bifurcation to the external iliac.Once the additional stent graft limbs were in place, the rupture was noted to be occluded and the event was resolved.As per the physician, the cause of the event was anatomy related, due to the expansion of the left iliac.No additional clinical sequelae 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: 8627818
• Report Number: 9612164-2019-01863
• Device Sequence Number: 2256618
• Product Code: MIH
• UDI-Device Identifier: 00613994761880
• UDI-Public: 00613994761880
• 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: 2012
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/21/2019

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: 03/20/2014
• Device Model Number: ENLW1624C124E
• Device Catalogue Number: ENLW1624C124E
• Device Lot Number: V01056904
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/09/2019
• Initial Report FDA Received Date: 05/21/2019
• 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: 83 YR