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

Model Number	ETLW1624C124E
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Occlusion (1984)
Date of Event	02/21/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 a 54mm abdominal aortic aneurysm.It was reported that when the patient returned for follow up approximately 5 weeks post implant, the patient's left limb was occlude d.No issue with the stent graft was noted on cta.As per the physician, the cause of the event cannot be determined.No additional clinical sequelae were reported and the patient is being monitored.
Additional Manufacturer Narrative
Additional information received on 21-mar-2019: intervention was completed with a fem-fem by pass performed.Film evaluation summary: the occluded left limbs were confirmed; however, the exact cause of the occlusion could not be determined from the films provided.Review of pre-implant ct¿s revealed that the proximal neck ranged in diameter from 23 ¿ 26mm along the 4cm neck length.The neck contained moderate thrombus, ranging in flow lumen diameter from 18 ¿ 22mm, and within the aaa sac moderate thrombus was also observed.The distal aortic diameter was of large caliber measuring 33mm.The iliac arteries were mildly tortuous, with mild levels of calcification and thrombus, and the common iliacs were dilated bilaterally to 21mm.The externals were slightly more tortuous, ranging in diameter from 7 ¿ 8mm on both the right and left side.Review of ct¿s from 5 weeks post-implant revealed that beginning at the level of the bifurcate flow divider, the gate, left/contra limb, and left extension were all 100 % occluded.Distal flow down the left leg reconstituted near the level of the left femoral artery.The bifurcate ipsi limb and right limb extension, and flow distal to the right limbs, were all patent.No stent graft kinks on the left side were observed.The id of the occluded left limbs ranged from ~11 ¿ 13mm within the aaa sac, and within the mid-length of the aneurysmal left common iliac expanded out to 21mm.The distal end of the left limb was positioned just above the left internal bifurcation, where the stent graft distal stent was seen severely compressed down to ~11mm id.It is possible that the severe compression of the distal end of the left limb from 21 ¿ 11mm in diameter, which was seen positioned near the left internal iliac bifurcation, may have led to the stent graft occlusion.It is unclear if the patient¿s pre-implant extensive thrombus seen within the aorta and external iliac tortuosity may have also been a factor.Medtronic, inc.(medtronic) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information in the time allotted and has provided as much information as is available to the company as of the submission date this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic or its employees caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects" or has "malfunctioned".These words are included in the fda 3500a form and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.Medtronic objects to the use of these words and others like it because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.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.

• 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: 8370759
• Report Number: 2953200-2019-00276
• Device Sequence Number: 1203944
• Product Code: MIH
• UDI-Device Identifier: 00643169467507
• UDI-Public: 00643169467507
• 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: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/21/2020
• Device Model Number: ETLW1624C124E
• Device Catalogue Number: ETLW1624C124E
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 02/24/2019
• Initial Date Received by Manufacturer: 02/22/2019
• Supplement Date Received by Manufacturer: 03/08/2019
• Initial Report FDA Received Date: 02/26/2019
• Supplement Report FDA Received Date: 03/29/2019
• 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: 65 YR