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

Model Number	ENLW1620C124E
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Injury (2348)
Date of Event	08/23/2017
Type of Reportable Event	Serious Injury
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 the returned for follow up.The ct revealed that there was a left distal type i endoleak.The physician elected to implant another endurant 16x24x156 stent graft.Per the physician, the cause of the distal type i endoleak was related to the patient¿s anatomy of disease progression.No additional clinical sequelae were reported and the patient is fine.
Additional Manufacturer Narrative
Film evaluation summary: the exact cause distal type i endoleak could not be determined from the films provided.Pre-implant anatomy is unknown, and earlier post-implant films were not available for review and comparison.Images during the intervention when the contra limb was extended with an endurant limb resolving the endoleak were also not provided.Ct¿s from 5- 1/2 years years post-implant revealed that an endurant stent graft system had been implanted in the patient.The bifurcate was positioned just below the lowest right renal artery, and a non-medtronic aortic cuff had been implanted near the level of the bifurcate.The aortic body and infrarenal neck were severely angulated 80 deg max a-p; however, there appeared to be an adequate proximal seal.The contra limb was seen floating within the aneurysmal left common iliac artery and there was a distal type i endoleak.The distal contra limb od measured 20mm, and the lcia diameter at that same level was ~24mm.Distal to the left limb, the lcia was acutely angulated ~90 deg laterally, and tapered down in diameter from 21 ¿ 13 ¿ 12mm along the 46mm length to the left hypogastric junction.It appears most likely that disease progression (iliac artery dilatation and angulation) contributed to the distal type i endoleak.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: 6875681
• Report Number: 2953200-2017-01455
• Device Sequence Number: 483427
• Product Code: MIH
• UDI-Device Identifier: 00613994761910
• UDI-Public: 00613994761910
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 10/23/2017

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: 09/27/2013
• Device Model Number: ENLW1620C124E
• Device Catalogue Number: ENLW1620C124E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/25/2017
• Initial Date Received by Manufacturer: 08/23/2017
• Supplement Date Received by Manufacturer: 09/28/2017
• Initial Report FDA Received Date: 09/19/2017
• Supplement Report FDA Received Date: 10/23/2017
• 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: 77 YR