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

Model Number	ETBF2313C124E
Medical Device Problem Code	Occlusion Within Device (1423)
Health Effect - Clinical Codes	Occlusion (1984); Claudication (2550)
Date of Event	01/17/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Other relevant device(s) are: etlw1613c93e, sn (b)(4), expiration date: 2018-05-09, (b)(4).Off-label, unapproved or contraindicated use (aortic neck diameter).Film evaluation summary: the exact cause of the stent graft occlusion and claudication could not be determined from the limited pre-implant films provided.Additional pre-implant ct¿s were not provided, the blood flow dynamics could not be assessed from the ct¿s provided, and a complete assessment of the patient anatomy could not be performed.Films during implant and post-implant were also not available for return; therefore, the stent graft in-vivo configuration and the occluded stent graft could not be assessed.It is possible that the occlusion was anatomy related; implanting within a small aorta.The films returned revealed that the patient¿s neck diameter was 17.8mm just below the lowest left renal artery, and ranged in diameter from 19 ¿ 17mm along the 45mm neck length.The distal aortic diameter was 20mm with areas of calcification seen.This may also have been caused by a patient condition: poor distal runoff, or an unknown coagulopathy that is now presenting.The patient¿s previous history of peripheral vascular disease may have also contributed.
Event or Problem Description
An endurant ii stent graft system was implanted in a patient for the endovascular treatment of a 48mm in diameter abdominal aortic aneurysm.The proximal neck was 18-17mm in diameter and 45mm in length.The right iliac arteries measured 10-11mm in diameter and the left iliac arteries measured 10-9-11mm in diameter.It was reported that there was left limb occlusion and the patient had claudication starting at the left buttock.The physician elected to perform a femoral to femoral bypass and the event was resolved.No additional clinical sequelae were reported and the patient is fine.
Additional Manufacturer Narrative
Corrected information: sex, date of birth.If information is provided in the future, a supplemental report will be issued.

• Brand Name: ENDURANT II BIFURCATED STENT GRAFT
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• MDR Report Key: 6312658
• Report Number: 2953200-2017-00165
• Device Sequence Number: 38244
• Product Code: MIH
• UDI-Device Identifier: 00613994991164
• UDI-Public: 00613994991164
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: P100021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/17/2017

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: 04/18/2018
• Device Model Number: ETBF2313C124E
• Device Catalogue Number: ETBF2313C124E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2017
• Initial Date Received by Manufacturer: 01/17/2017
• Supplement Date Received by Manufacturer: 01/17/2017
• Initial Report FDA Received Date: 02/08/2017
• Supplement Report FDA Received Date: 09/28/2017
• 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