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	07/21/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Other relevant device(s) are: (catalog number enew1010c82e, serial number (b)(4), use by date 2013-12-01and (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 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 showed that there appears to be a type iii separation endoleak on the right side and total occlusion of the left limb due to a kink.The physician elected to implant two endurant ii stent graft limbs [16x16x93 and 16x13x156] to bridge separation into the external iliac artery.The procedure was completed successfully without further complications.The physician believed that the type iii separation endoleak was due to aneurysm remodeling.Per the physician, the cause of the stent graft limb kink was unknown.No additional clinical sequelae were reported and the patient is fine.
Additional Manufacturer Narrative
Film evaluation summary the exact cause of the right limb detachment and bilateral limb occlusion could not be determined from the films provided.The anatomy at implant is unknown, and earlier follow up films were not available for review and comparison.Ct¿s returned from 4 years post-implant revealed that the patient¿s aaa measured 48mm and widespread contrast was observed.In addition, both the right common iliac artery (50mm diameter) and the left common iliac (54mm diameter) were aneurysmal.The films also confirmed that the bifurcate ipsi limb had detached from the right limb extension, resulting in a type iii separation endoleak and an occluded right limb extension.The limbs had separated ~20 ¿ 30mm and were also radially off-set; ~30mm centerline and 40° max angulation.The amount of initial junctional overlap is unknown.It is possible that aneurysm morphology changes and disease progression may have contributed to this event.On the left/contra side, the contra limb and extension were also 100% occluded.At the left iliac bifurcation, an acute vessel angulation and resulting stent graft kink of the left limb extension was observed which may have contributed.It is also possible that bilaterally extending down into the external iliacs, or a patient condition such as poor distal runoff may have been a contributing factor.On both sides the distal blood flow reconstituted in the external iliacs just distal to the limbs.Films from the intervention where two endurant ii stent graft limbs were implanted to bridge the separation, were not available.It is unknown what (if any) intervention was performed for the occluded left limbs.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: 6796581
• Report Number: 2953200-2017-01297
• Device Sequence Number: 16357494
• Product Code: MIH
• UDI-Device Identifier: 00613994762375
• UDI-Public: 00613994762375
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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
• Report Date (Section B): 08/17/2017

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: 04/20/2014
• Device Model Number: ENBF3616C166E
• Device Catalogue Number: ENBF3616C166E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/24/2017
• Initial Date Received by Manufacturer: 07/22/2017
• Supplement Date Received by Manufacturer: 08/17/2017
• Initial Report FDA Received Date: 08/16/2017
• Supplement Report FDA Received Date: 09/12/2017
• 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: 85 YR