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

Model Number	ENLW1624C124E
Medical Device Problem Codes	Failure To Adhere Or Bond (1031); Leak/Splash (1354)
Health Effect - Clinical Code	Injury (2348)
Date of Event	10/09/2017
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 the patient for the treatment of a 57mm abdominal aortic aneurysm.However, it was reported that during a ct examination performed approximately 6 years post implant, it was observed that a limb had loss seal resulting in a type ib endoleak.It was reported that the endoleak was successfully treated by extension of the contralateral limb down to the hypogastric artery with a larger diameter limb.It was reported that the cause of the event, as per the physician, cannot conclusively be determined however, disease progression may have been a contributor.No additional clinical sequelae were reported and the patient is fine.
Additional Manufacturer Narrative
Films review summary: the exact cause of the left limb migration and distal type i endoleak could not be determined from the films provided.The anatomy at implant is unknown, and earlier post-implant films were not available for comparison.Ct¿s retuned from 6 years post-implant confirmed that the distal end of the left bell-bottom limb appeared to have pulled out of the left common iliac artery, and was floating within the aaa sac with a distal type i endoleak.The distal left limb od measured ~23mm, and the left common iliac artery was aneurysmal measuring ~26mm average diameter.There was also acute left limb angulation observed as it coursed down into the sac.It appears likely that there has been disease progression and possible aneurysm morphology changes that may have contributed to these events.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; galway
• MDR Report Key: 6992648
• Report Number: 2953200-2017-01671
• Device Sequence Number: 19083939
• Product Code: MIH
• UDI-Device Identifier: 00613994761880
• UDI-Public: 00613994761880
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 11/28/2017

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: 05/26/2013
• Device Model Number: ENLW1624C124E
• Device Catalogue Number: ENLW1624C124E
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/09/2017
• Supplement Date Received by Manufacturer: 11/08/2017
• Initial Report FDA Received Date: 11/01/2017
• Supplement Report FDA Received Date: 11/28/2017
• 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: 63 YR