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

Model Number	ETLW1620C156E
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Injury (2348)
Date of Event	05/12/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant products: etlw1616c124e sn (b)(4), expiration date: 2018-11-29, udi # unknown.Film evaluation summary: the exact cause of the reported events could not be determined from the pre-implant films provided.Films during implant, post-implant, as well as during the intervention were not available for return.The in-vivo configuration of the stent grafts could not be assessed.Pre-implant films revealed that the patient had a severely angulated neck; the infrarenal neck measured approximately 90 deg in the rt-lt axis.The neck was also contained thrombus and areas of calcification.The common iliacs were also found to be tortuous and calcified; bilaterally.The take-off of the right common iliac was acutely angulated approximately 90 deg laterally.It is possible that implanting within the tortuous and calcified iliac artery may have contributed to the distal type i endoleak seen 1 week post-implant.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 iis stent graft system was implanted in a patient for the endovascular treatment of an 8.0 cm abdominal aortic aneurysm.The proximal neck angulation of approximately 60 degrees.It was reported that, when the physician brought the patient back to the operating room for a right iliac limb extension the cta showed what appeared to be a type ib endoleak in the right common iliac artery.The or angio confirmed the type ib endoleak.The decision was made to implant an endurant stent graft and the iliac endoleak resolved.No additional clinical sequelae were reported and the patient is fine.
Additional Manufacturer Narrative
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: 6616415
• Report Number: 2953200-2017-00930
• Device Sequence Number: 1123106
• Product Code: MIH
• UDI-Device Identifier: 00643169467545
• UDI-Public: 00643169467545
• 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: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/13/2017

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: 09/15/2018
• Device Model Number: ETLW1620C156E
• Device Catalogue Number: ETLW1620C156E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/16/2017
• Initial Date Received by Manufacturer: 05/13/2017
• Supplement Date Received by Manufacturer: 05/13/2017
• Initial Report FDA Received Date: 06/06/2017
• Supplement Report FDA Received Date: 10/04/2017
• 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: 72 YR