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

Model Number	ETLW1613C156E
Medical Device Problem Code	Occlusion Within Device (1423)
Health Effect - Clinical Codes	Occlusion (1984); Injury (2348)
Date of Event	12/01/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Failure to follow instructions use of device to treat iliac aneurysm.Other relevant device(s) are: (catalog number etbf2316c124e, serial number (b)(4), use by date 2017-01-07 and upn# (b)(4)).
Event or Problem Description
An endurant ii stent graft system was implanted in a patient for the endovascular treatment of a 41mm aneurysm in the right common iliac artery.It was reported that the patient's ct revealed an occlusion in the right ipsilateral limb.The patient received treatment with a femoral-femoral bypass being performed.As per the physician the cause of the event cannot be determined.No additional clinical sequelae were reported, and the patient is fine.
Additional Manufacturer Narrative
Film evaluation summary: the exact cause of the occlusion could not be determined from the films provided.Pre-implant films were not returned; however, a sizing worksheet prior to implant revealed that the patient had been treated for a 4cm right common iliac artery.The proximal neck measured 19mm just below the lowest left renal artery, and the abdominal aorta ranged from 22 ¿ 24mm in diameter.Earlier post-implant films were not available.Review of ct¿s from 2 years post-implant revealed that there was thrombus (~2mm max thickness) within the bifurcate aortic body, and beginning at the flow divider the entire length of the contra limb was 100 % occluded.Distal to the right limb the external iliac was also occluded, and blood flow resumed down the right leg at the femoral artery.No thrombus/occlusion was seen within the bifurcate ipsi limb, and distal to the left limb the vessels were also patent.No obvious stent graft kinks, compression, or excessive angulation was observed which could help explain this event.The flow lumen id of the contra limb ranged from 7 ¿ 9mm within the gate, 11 ¿ 13mm within the rcia, and ~11mm id at the distal end of the right limb within the right external, and the right external was large in caliber with only slight calcification present.Analysis of the returned films did not reveal any stent graft or anatomical characteristics that could explain the observed occlusion.Angiograms at implant and earlier follow-up¿s were not available for review; the blood flow dynamics could not be assessed from the ct¿s provided.This may have been caused by a patient condition: poor distal runoff, an unknown coagulopathy that is now presenting, or a previous history of pad.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: 7132887
• Report Number: 2953200-2017-02009
• Device Sequence Number: 1259959
• Product Code: MIH
• UDI-Device Identifier: 00643169467583
• UDI-Public: 00643169467583
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P100021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/07/2018

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: 11/03/2017
• Device Model Number: ETLW1613C156E
• Device Catalogue Number: ETLW1613C156E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2018
• Initial Date Received by Manufacturer: 12/04/2017
• Supplement Date Received by Manufacturer: 01/30/2018
• Initial Report FDA Received Date: 12/20/2017
• Supplement Report FDA Received Date: 02/07/2018
• 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: 74 YR
• Patient Weight: 103