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	08/03/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.The left iliac artery measured 11-12-11 mm in diameter with mild calcification.The right iliac artery measured 10-12-13 mm in diameter with mild calcification.The distal aorta was approximately 20 mm in diameter it was reported that the final angiogram showed what appeared to be a blush in the right proximal common iliac.The physician stated there was heavy calcification in the proximal right common iliac.A reliant balloon had been used in the same area as the leak which may have contributed to the event.The physician stated that the event is anatomy related (calcification).Another endurant ii limb was implanted, resolving the endoleak.No additional clinical sequelae were reported and the patient is fine.
Additional Manufacturer Narrative
Film review: the cause of the reported blush seen coming from the proximal portion of the right common iliac artery could not be determined from the limited films provided.Analysis of the returned films did not reveal any device characteristics that could explain the reported event.The complete anatomy at implant could not be assessed, and other than a single image after the devices had been implanted, no additional films during implant were available.Images during ballooning were also not provided.It is possible that the reported ballooning within the heavily calcified iliac artery may have led to a fabric tear and type iii fabric endoleak.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: 6827053
• Report Number: 2953200-2017-01349
• Device Sequence Number: 1430457
• 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): 08/30/2017

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: 06/19/2019
• Device Model Number: ETLW1620C156E
• Device Catalogue Number: ETLW1620C156E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/04/2017
• Initial Date Received by Manufacturer: 08/03/2017
• Supplement Date Received by Manufacturer: 08/30/2017
• Initial Report FDA Received Date: 08/29/2017
• Supplement Report FDA Received Date: 09/21/2017
• 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: 78 YR