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

Model Number	ENBF3616C166E
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Injury (2348)
Date of Event	01/14/2015
Type of Reportable Event	Serious Injury
Event or Problem Description
An endurant stent graft system was implanted in the patient for the endovascular treatment of a 10 cm in diameter abdominal aortic aneurysm.The bifurcate was implanted from the left side (16x24x93) limb implanted on the right side.An endurant limb was implanted to treat a right internal iliac aneurysm.The right internal iliac artery was coiled and covered during the procedure.The patient was lost to follow up.It was reported that the patient presented emergently with abdominal pain.A ct was performed and a distal type i endoleak was observed in the left endurant ipsilateral stent graft limb.The patient was referred to the original implanting physician and an intervention was performed.The physician elected to extend the left limb with another endurant stent graft limb and implanted an endurant aortic cuff.The endoleak was resolved after the intervention procedure.Per the physician the cause of the event was due to the patient anatomy of continued aortic dilatation distal to the existing stent graft.The ipsilateral limb of the endurant bifurcate extended approximately 3 cm into the left iliac artery.The portion of the artery that was not covered by the stent graft had continued to deteriorate growing to a size of approximately 17 mm in diameter allowing for a leak around the 16 mm diameter ipsilateral limb.The physician did not believe the event was related to the device or related to a placement issue.No additional clinical sequelae were reported and the patient is fine.

• Brand Name: ENDURANT 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: 6953984
• Report Number: 2953200-2017-01588
• Device Sequence Number: 11127908
• Product Code: MIH
• UDI-Device Identifier: 00613994762375
• UDI-Public: 00613994762375
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 10/17/2017

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: 02/26/2014
• Device Model Number: ENBF3616C166E
• Device Catalogue Number: ENBF3616C166E
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/21/2017
• Initial Report FDA Received Date: 10/17/2017
• 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: 72 YR
• Patient Weight: 101