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

Model Number	ENBF2516C166E
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Rupture (2208)
Date of Event	02/25/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant products: enlw1620c93e sn (b)(4), expiration date: 2013-12-21, udi # (b)(4).Enew2020c82e sn (b)(4), expiration date: 2014-01-05, udi # (b)(4).A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
An endurant stent graft system was implanted in a patient for the endovascular treatment of an abdominal aortic aneurysm.It was reported that the patient presented emergently with abdominal pain.A non-contrast ct was done and the patient was diagnosed with a ruptured abdominal aortic aneurysm.The patient was then taken to the operating room.An angiogram in the or showed only a type ii endoleak.The physician decided to implant an aui device and perform a femoral-femoral bypass.A 24x14x102 device was implanted in the existing stent graft on the right ipsilateral side.It was noted that it was landed 1cm proximal to the previous stent graft.A 16x16x93 extension was also implanted along with a talent occluder in the contralateral limb on the left side.An angiogram then revealed a proximal type i endoleak, so the physician decided to use another manufacturer¿s stent.The physician placed the first stent low so they used a second one.Per the physician, the cause of the ruptured aneurysm was unknown and the cause of the proximal type i endoleak, after the aui device was implanted, was also unknown.No additional clinical sequelae were reported and the patient is fine.
Additional Manufacturer Narrative
A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Correction: a 28x14x102 device was implanted in the existing stent graft on the right ipsilateral side.It was noted that it was landed 1cm proximal to the previous stent graft, which was ~ 8mm below the lowest left renal artery.The event was reportedly resolved and the procedure was completed.The next day, the patient's creatinine had increased from 2.3 pre-procedure to 3.The patient was not making any urine.
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 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: 6419390
• Report Number: 2953200-2017-00429
• Device Sequence Number: 18840813
• Product Code: MIH
• UDI-Device Identifier: 00613994762221
• UDI-Public: 00613994762221
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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,Followup,Followup
• Report Date (Section B): 04/13/2017

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 01/15/2014
• Device Model Number: ENBF2516C166E
• Device Catalogue Number: ENBF2516C166E
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/25/2017
• Supplement Date Received by Manufacturer: Not provided; 04/13/2017
• Initial Report FDA Received Date: 03/20/2017
• Supplement Report FDA Received Date: 05/08/2017; 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: Life Threatening; Required Intervention
• Patient Age: 88 YR