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

Model Number	ENLW1613C82E
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Abdominal Pain (1685)
Date of Event	12/04/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 94mm diameter abdominal aortic aneurysm.It was reported that the patient presented to the er with abdominal pain.It was noted on ct exam that the patient had a type iii separation endoleak of the left iliac.It was noted that the patient received treatment on (b)(6) 2017 with the placement of an endurant stent graft limb (16x16x156mm).It was reported that the endoleak was resolved by bridging of the stent grafts together.As per the physician, the cause of the event was due to aortic anatomy remodelling.No additional clinical sequelae were reported, and the patient is fine.
Additional Manufacturer Narrative
Film evaluation summary several still angiograms and a single ct from an unknown post-implant study were returned.No scale was seen on the films; therefore, no stent graft or vessel measurements could be performed.The films confirmed that the left iliac limb had detached from the bifurcate ipsi limb and there was a resulting type iii junctional endoleak.The bifurcate ipsi limb on the right side appeared essentially straight, and the detached left iliac limb at the former overlapping junction was angulated ~90 deg to the junction.The distal end of the detached left limb appeared to still be within the left iliac artery, and the left limb was patent.No issues were seen with the contra limb and right limb extension.The exact cause of the left limb detachment and resulting type iii junctional endoleak could not be determined from the limited films provided.The anatomy at implant is unknown, the amount of component overlap at implant is unknown, and earlier post-implant films were not available for review.Several still angiograms and a single ct image confirmed that the left iliac limb had detached from the bifurcate ipsi limb and there was a resulting type iii junctional endoleak.The detached limbs were angulated ~90 deg to each other and the detachment occurred within the unsupported distal aaa sac.The distal end of the detached left limb appeared to still be within the left iliac artery and the left limb was patent.No scale was seen on the films; therefore, no stent graft or vessel measurements could be performed.It is possible that aneurysm morphology changes with increased aortic and iliac tortuosity may have led to the detachment.If information is provided in the future, a supplemental report will be issued.

• Brand Name: ENDURANT 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: 7132867
• Report Number: 2953200-2017-02004
• Device Sequence Number: 13732922
• Product Code: MIH
• UDI-Device Identifier: 00613994761996
• UDI-Public: 00613994761996
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P100021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/17/2018

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: 04/25/2013
• Device Model Number: ENLW1613C82E
• Device Catalogue Number: ENLW1613C82E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2017
• Initial Date Received by Manufacturer: 12/04/2017
• Supplement Date Received by Manufacturer: 12/22/2017
• Initial Report FDA Received Date: 12/20/2017
• Supplement Report FDA Received Date: 01/17/2018
• 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: 71 YR