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

Model Number	ETLW1610C93E
Medical Device Problem Code	Occlusion Within Device (1423)
Health Effect - Clinical Codes	Occlusion (1984); Pain (1994)
Date of Event	09/10/2017
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 of a 57mm diameter abdominal aortic aneurysm.The infrarenal neck was 22-25mm in diameter and 28mm in length with 19.3 angulation.There was mild tortuosity in the limb.The patient had atherectomy and common femoral endarterectomy just prior to index stent graft procedure.It was reported that the patient presented in er with leg pain and cold leg.It was also noted that the patient¿s leg pain started in mid-thigh and foot of the right leg 3 days prior.Thrombolysis was performed and flow was restored.Per the physician the limb occlusion was result of outflow issues in sfa and cfa and the limb looked fully dilated and properly sized.No additional clinical sequelae were reported and the patient is fine.

• 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: 6933730
• Report Number: 2953200-2017-01550
• Device Sequence Number: 11090864
• Product Code: MIH
• UDI-Device Identifier: 00643169467606
• UDI-Public: 00643169467606
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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
• Report Date (Section B): 09/13/2017

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: 01/18/2019
• Device Model Number: ETLW1610C93E
• Device Catalogue Number: ETLW1610C93E
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/13/2017
• Initial Report FDA Received Date: 10/10/2017
• 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: 56 YR