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

Model Number	ENBF3216C166E
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Injury (2348)
Date of Event	09/11/2017
Type of Reportable Event	Serious Injury
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
An endurant stent graft system was implanted in a patient for the endovascular treatment of a pre-operatively ruptured abdominal aortic aneurysm.It was reported that when the patient returned for follow up a dilated neck and distal seal zones were observed.It was reported that there were type ib endoleaks in both iliac arteries and that there was a proximal type i endoleak.The endoleaks appear to be related to the dilated proximal and distal zones.The physician explanted the stent grafts and treated surgically.The patient's creatinine has gone from 2.8 to 1.6.No additional clinical sequelae were reported and the patient is fine.
Additional Manufacturer Narrative
Additional information received reported that there was no rupture prior to the implant or explant of the device.Device evaluation summary the exact cause of the proximal type i and distal type i x2 endoleak could not be determined from the films provided.Earlier post-implant films were not available for review and comparison, and the post-implant films provided were non-contrast; therefore, no assessment of any endoleak could not be performed.However, it appears likely that the cause was due to disease progression.Pre-implant films revealed that the proximal neck diameter just below the renals measured ~25mm, was ~10mm in length, moderately angulated, and contained irregular thrombus with areas of calcification.Non-contrast films from 6 years post-implant showed that the bifurcate may have migrated into the sac.The aortic diameter at the level of the bifurcate proximal margin was 50mm, and the bifurcate angulated ~70 deg a-p relative to the distal aorta.There was also lack of distal limb radial apposition within both common iliac arteries.The rcia diameter had increased to 37mm and the lcia diameter had increased to 20mm.It appears most likely that disease progression was the primary cause of the endoleaks.Implanting within a short neck which contained thrombus, calcification, and was moderately angulated may have also contributed to the type ia endoleak.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: 6903257
• Report Number: 2953200-2017-01536
• Device Sequence Number: 16496003
• Product Code: MIH
• UDI-Device Identifier: 00613994762429
• UDI-Public: 00613994762429
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: P100021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/24/2017

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: 08/09/2013
• Device Model Number: ENBF3216C166E
• Device Catalogue Number: ENBF3216C166E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/11/2017
• Initial Date Received by Manufacturer: 09/11/2017
• Supplement Date Received by Manufacturer: 09/29/2017
• Initial Report FDA Received Date: 09/29/2017
• Supplement Report FDA Received Date: 10/24/2017
• 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: 69 YR