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

Model Number	ETBF2516C166E
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Injury (2348)
Date of Event	06/29/2017
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 an abdominal aortic aneurysm.It was reported that a follow-up non contrast ct showed an enlarging right common iliac artery aneurysm.The physician did an angiogram on the same day and found that there was a disunion between the main body graft and the limb extension.There is an endoleak on angio.An endurant iliac stent graft was implanted.The physician stated the cause of the event cannot be determined.No clinical sequelae were reported and the patient will be monitored by their physician.
Additional Manufacturer Narrative
Additional information received reported the physician elected to implant a 16x16x156 stent graft bridge.There were no issues observed during the intervention and the endoleak was resolved.No additional clinical sequelae were reported and the patient is fine.Film evaluation summary the exact cause of the limb detachment could not be determined from the single image provided.The anatomy at implant is unknown, and earlier post-implant images were not available for return.A single still post-implant angiogram confirmed a stent graft disconnection between the bifurcate ipsi limb and the limb extension.The limbs were separated by ~10mm and there was slight radial off-set; however, no limb angulation was noted from the single a-p view.The amount of limb overlap at implant is unknown.It is possible that the detachment was caused by aneurysm morphology changes that occurred during the nearly 4 year implant duration.Images during the intervention/relining which resolved the endoleak were not available.

• Brand Name: ENDURANT II BIFURCATED STENT GRAFT
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• MDR Report Key: 6734078
• Report Number: 2953200-2017-01159
• Device Sequence Number: 1095396
• Product Code: MIH
• UDI-Device Identifier: 00613994991270
• UDI-Public: 00613994991270
• 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: 2013
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/22/2015
• Device Model Number: ETBF2516C166E
• Device Catalogue Number: ETBF2516C166E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/20/2017
• Initial Date Received by Manufacturer: 06/29/2017
• Supplement Date Received by Manufacturer: 07/27/2017
• Initial Report FDA Received Date: 07/21/2017
• Supplement Report FDA Received Date: 08/22/2017
• 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: 66 YR