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

Model Number	ETBF2513C124E
Medical Device Problem Codes	Occlusion Within Device (1423); Malposition of Device (2616)
Health Effect - Clinical Code	Occlusion (1984)
Date of Event	01/13/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Film evaluation summary: the cause of the left limb occlusion and coverage of the left internal iliac artery at implant could not be determined from the limited images provided.Pre-implant ct¿s were not available for return; therefore a complete assessment of the patient¿s anatomy could not be performed.Images during implant were also not available.The films returned during an intervention two-months post-implant revealed that the left/ipsi limb was completely occluded beginning at the level of the flow divider.The left internal iliac, left external, and vessels distal to the left limb were also occluded.The right/contra limb was patent.An image after the reported embolectomy and implant of the 8x57 bare metal stent confirmed that the previously seen occlusion had been resolved.The iliac arteries were non-tortuous bilaterally and no obvious stent graft kinks were observed.This may be anatomy and user related.It is possible that due to the patient¿s short left iliac (2 cm length) which was inadvertently covered by the ipsi limb at implant, that during the physician¿s attempts to uncover the left internal the stent graft may have accordioned, leading to a reduction in the flow lumen and the eventual stent graft occlusion.Some calcification in the iliac arteries was reported, which may have also contributed to the limb occlusion.
Event or Problem Description
An endurant ii stent graft system was implanted in a patient for the endovascular treatment of a 5.5 cm in diameter abdominal aortic aneurysm.Vessel morphology was reported as the proximal aortic neck is 20 mm in diameter and 30 mm in length, there is some calcification in the iliac arteries.It was reported that during the primary procedure the bifurcated ipsilateral limb occluded the left internal iliac artery.The patient¿s left iliac measured 2 cm long.The physician attempted to accordion the ipsilateral limb during the initial procedure.However the left internal iliac artery was inadvertently covered.The physician elected to perform an embolectomy, implanted a balloon expandable 8x57 bare metal stent, and the blood flow was restored.The physician stated that the cause of the event is due to patient anatomy.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: 6301686
• Report Number: 2953200-2017-00151
• Device Sequence Number: 1563630
• Product Code: MIH
• UDI-Device Identifier: 00613994991225
• UDI-Public: 00613994991225
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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): 01/13/2017

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: 05/26/2018
• Device Model Number: ETBF2513C124E
• Device Catalogue Number: ETBF2513C124E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/17/2017
• Initial Date Received by Manufacturer: 01/13/2017
• Supplement Date Received by Manufacturer: 01/13/2017
• Initial Report FDA Received Date: 02/03/2017
• 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: 74 YR