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

Model Number	ETLW1610C199E
Medical Device Problem Code	Occlusion Within Device (1423)
Health Effect - Clinical Code	Occlusion (1984)
Date of Event	03/01/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Conclusion: failure to follow instructions (oversizing the stent graft).
Event or Problem Description
An endurant iis stent graft system was implanted in a patient for the endovascular treatment an abdominal aortic aneurysm.It was reported that an unknown date the patient presented for another medical condition and the ct revealed that there was endurant iliac limb occlusion.The endurant right iliac limb up to the aortic bifurcation was occluded.No intervention was performed due to multiple infections that the physician noted were unrelated to the device or procedure.The physician stated that the cause of the event was related to the oversizing of the endurant iliac limb.No clinical sequelae were reported and the patient is being monitored by their physician.
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: 6500588
• Report Number: 2953200-2017-00619
• Device Sequence Number: 687501
• Product Code: MIH
• UDI-Device Identifier: 00643169467620
• UDI-Public: 00643169467620
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: P100021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/24/2017

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: 03/01/2018
• Device Model Number: ETLW1610C199E
• Device Catalogue Number: ETLW1610C199E
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/24/2017
• Supplement Date Received by Manufacturer: 03/24/2017
• Initial Report FDA Received Date: 04/18/2017
• Supplement Report FDA Received Date: 10/02/2017
• 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: Other
• Patient Age: 78 YR