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

Model Number	ETLW1620C93E
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Occlusion (1984); Vascular Dissection (3160)
Date of Event	03/24/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Film evaluation summary: the cause of the left iliac artery occlusion reported on the day following the implant could not be determined from the pre-images p rovided.Angio¿s at implant were not available for review, the blood flow dynamics could not be assessed from the ct¿s provided, and post-cta¿s were also not available.Pre-implant films noted that the left iliac artery was moderately tortuous.There was an acute bend seen near the left internal bifurcation, calcification was seen along the proximal section of the left external iliac artery, and the left external artery diameter was noted as 8mm.Cross-section images of the iliac arteries were not returned, and the vessels below the level of the pelvis were not seen in the returned films.The cause of the occlusion appears to have most likely been anatomy related.During the procedure another manufacturer's bare stent was implanted in the left external iliac distal to the stent graft, the occluded segment was from a dissection in the left external iliac distal to the bare stent.The occlusion was reported as not associated with the stent graft.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 a 5.5 cm abdominal aortic aneurysm.During the procedure, another manufacturer's bare stent was implanted in the left external iliac because the physician did not like the way that it looked.It was reported that there was a short segment left iliac occlusion on the day following the procedure.It was further reported that the occlusion segment was a dissection in the left external iliac distal to a segment treated with a self-expanding bare stent, and was not an issue with the stent graft.The post implant pulse in the left foot was diminished, but was not a concern initially.However, it was later noted that the there was no pulse in the foot.A ct was performed and the dissection was discovered.An additional stent was placed across the dissected segment to successfully re-establish distal flow.The physician commented that it was a mistake to have not looked more distal on the run post bare stent placement because the dissected segment would have been identified during the index procedure.Per the physician, the cause of the event was unknown.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 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: 6500795
• Report Number: 2953200-2017-00623
• Device Sequence Number: 1202233
• Product Code: MIH
• UDI-Device Identifier: 00643169467514
• UDI-Public: 00643169467514
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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): 03/24/2017

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 05/12/2018
• Device Model Number: ETLW1620C93E
• Device Catalogue Number: ETLW1620C93E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/27/2017
• Initial Date Received by Manufacturer: 03/24/2017
• Supplement Date Received by Manufacturer: 03/24/2017
• Initial Report FDA Received Date: 04/18/2017
• Supplement Report FDA Received Date: 10/02/2017
• 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; Disability
• Patient Age: 78 YR