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

Model Number	ETLW1628C199E
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Injury (2348)
Date of Event	02/15/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Film evaluation summary: the exact cause of the 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 return and comparison.The films returned 45 months post-implant confirmed that the right/contra limb had pulled out of the aneurysmal right iliac artery and was floating within the distal portion of the 10cm max diameter aaa sac.There was a distal type i endoleak.The distal od of the right/contra limb measured 29mm and the diameter of the rcia was ~40mm.There was also a marginal proximal seal, with contrast seen on the posterior side of the short proximal neck; however, it could not be confirmed if the contrast was pressurizing the proximal aaa sac.It appears most likely that the cause of the limb migration leading to the distal type i endoleak was due to disease progression; iliac artery dilatation.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 an abdominal aortic aneurysm.It was reported that, approximately three years and nine months post index procedure a ct revealed a distal type i endoleak in the endurant stent graft limb.The physician elected to embolize the right external iliac artery and implanted an endurant stent graft limb that extended into the external iliac artery.The procedure was completed with the distal type i endoleak successfully excluded.Per the physician, the cause of the event was due to disease progression in the aneurysmal iliac artery.The disease progression led the aneurysmal common iliac artery diameter to exceed the 28 mm diameter of the endurant stent graft limb.No additional clinical sequelae were reported and the patient is fine.
Additional Manufacturer Narrative
Corrected information: sex, date of birth.If information is provided in the future, a supplemental report will be issued.

• Brand Name: ENDURANT II 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: 6401365
• Report Number: 2953200-2017-00386
• Device Sequence Number: 13621431
• Product Code: MIH
• UDI-Device Identifier: 00613994991362
• UDI-Public: 00613994991362
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: P100021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/16/2017

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: 05/10/2014
• Device Model Number: ETLW1628C199E
• Device Catalogue Number: ETLW1628C199E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2017
• Initial Date Received by Manufacturer: 02/16/2017
• Supplement Date Received by Manufacturer: 02/16/2017
• Initial Report FDA Received Date: 03/13/2017
• Supplement Report FDA Received Date: 10/02/2017
• 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: 75 YR