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

Model Number	ETLW1616C93E
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Injury (2348)
Date of Event	10/08/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Fdc 18 failure to follow instruction (undersized stent graft).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 of unknown size on (b)(6) 2013.It was reported that during a follow-up ct on (b)(6) 2017, a possible type ib endoleak was noted.The right external iliac was also occluded.The physician stated the cause of the event was anatomy related; continued vessel dilation and undersized stent graft.On (b)(6) 2018 the physician extended the stent graft limbs to provide seal.No additional clinical sequelae were reported and the patient will be monitored by their physician.
Additional Manufacturer Narrative
Evaluation summary: the likely cause of the reported possible type ib endoleak could not be determined from the films provided.Returned pre-implant ct¿s revealed that the patient had a 50mm max diameter infrarenal aaa.The neck diameter ranged from 23 ¿ 21mm along a 20mm length, and the neck was moderately calcified and severely angulated ~80 deg rt-lt.The common iliac arteries were moderately tortuous; especially on the right side.The right common iliac artery ranged in diameter from 12 ¿ 15 - 14 ¿ 18 mm, the left common iliac ranged in diameter from 13 ¿ 15 ¿ 16 ¿ 13 mm.Earlier post-implant films were not available for comparison.Review of ct¿s from 4 years post-implant revealed that the maximum diameter aaa had increased to 69mm.The bifurcate was positioned 5 ¿ 10 mm below the lowest left renal artery and there was a marginal proximal seal and a possible type ia endoleak.Just below the bifurcate proximal margin, 15mm below the left renal, the neck diameter was ~31mm.Both common iliac arteries were tortuous, which resulted in lack of stent graft opposition on the distal end of both iliac limbs.However, there appeared to be adequate distal sealing length bilaterally, and no clear distal type i endoleak could be confirmed.Distal to both limbs the common iliac arteries had increased in diameter from 19 ¿ 18mm; bilaterally.Near the origin of the right external the iliac narrowed from 11 ¿ 6 ¿ 11mm across a 2cm length segment that was tortuous.There appears to have been disease progression with neck and common iliac artery dilatation at the proximal and distal seal zones.Minimal contrast seen in the post-implant ct¿s did not allow for a thorough assessment of any possible endoleak.However, a proximal type i endoleak appeared likely, and bilateral distal type ib endoleaks could not be ruled out.Aortic neck & iliac tortuosity may have also contributed to the marginal proximal and distal seals, and vessel tortuosity may have also led to the lumen narrowing reported within the right eternal iliac.Stent graft undersizing also may have contributed.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: 7217965
• Report Number: 2953200-2018-00141
• Device Sequence Number: 11066025
• Product Code: MIH
• UDI-Device Identifier: 00613994991584
• UDI-Public: 00613994991584
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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): 06/08/2018

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: 03/22/2015
• Device Model Number: ETLW1616C93E
• Device Catalogue Number: ETLW1616C93E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2018
• Initial Date Received by Manufacturer: 12/07/2017
• Supplement Date Received by Manufacturer: 06/04/2018
• Initial Report FDA Received Date: 01/25/2018
• Supplement Report FDA Received Date: 06/08/2018
• 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: 85 YR