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

Model Number	ETLW1613C156E
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	Occlusion (1984)
Date of Event	02/10/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
An endurant ii stent graft system was implanted in a patient for the endovascular treatment a 5 cm in diameter abdominal aortic aneurysm.The endurant bifurcated stent graft was deployed below the renal arteries without issue.The contralateral gate was cannulated without issue.A sizing marker pig tail was placed with in the bifurcated stent graft extending to the left common iliac.An angiogram from the left sheath was performed.The physician counted 13 marks from flow divider to hypogastric artery.Over the wire an endurant 16x13x124 limb was advanced to the level of the flow divider.At this point the 124 length limb was approximately 3cm proximal to hypogastric artery therefore the physician removed the endurant 16x13x124 limb and an endurant 16x13x156 limb was advanced and deployed extending from flow divider to hypogastric artery.The delivery system was removed.The remainder of the endurant bifurcated stent graft was deployed and the delivery system was removed.The stent grafts were ballooned using a reliant balloon at the proximal, distal, and overlap sections.On the final angiogram it was noticed that the left hypogastric was not filling due to the 13mm of the endurant stent graft limb crossing the origin of the hypogastric artery, deploying lower than intended.The physician attempted to use a sheath and reliant balloon to "push up" the stent graft however there was no change.The physician completed the evar without further intervention and the patient was closed without issue.The physician did not expect the patient to have any issues with the left hypogastric artery being covered.Per the physician, the cause of the event was most likely related to the c-arm moving or the patient moving during the case.No additional clinical sequelae were reported and the patient is fine.
Additional Manufacturer Narrative
Corrected information: sex, date of birth.If information is provided in the future, a supplemental report will be issued.

• 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: 6385556
• Report Number: 2953200-2017-00348
• Device Sequence Number: 10978217
• Product Code: MIH
• UDI-Device Identifier: 00643169467583
• UDI-Public: 00643169467583
• 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: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/10/2017

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: 01/17/2019
• Device Model Number: ETLW1613C156E
• Device Catalogue Number: ETLW1613C156E
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/10/2017
• Supplement Date Received by Manufacturer: 02/10/2017
• Initial Report FDA Received Date: 03/07/2017
• Supplement Report FDA Received Date: 09/29/2017
• 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: 60 YR