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

Model Number	ETBF2513C166E
Medical Device Problem Code	Occlusion Within Device (1423)
Health Effect - Clinical Codes	Occlusion (1984); Injury (2348)
Date of Event	05/10/2018
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 an 53mm abdominal aortic aneurysm.The diameter of the aortic bifurcation was noted as 21mm.The proximal neck diameter of the right external iliac measured 10mm, 78mm in length and the distal neck diameter noted as 11mm.The lcia was observed to be tortuous.It was reported that a ct scan carried out approximately a year later showed that the right limb was occluded.The physician attributed the cause of the event to possible crushing/narrowing of the limb near the distal aorta.The event is not resolved.No additional clinical sequelae were reported and the patient is being monitored.
Additional Manufacturer Narrative
Additional information received on this case reported that the physician performed a revision to fix the occluded limb.An endurant ii 25x25x49 cuff was placed in the existing main body stent graft and an extension limb (16x13x124mm) was implanted in the right ipsi side to realign graft.Another non mdt vbx device was implanted in the right limb to reinforce area and as that device appeared kinked, another device was extended distally to the external artery.Ballooning was performed with reliant in the proximal main body and iliac limb and kissing balloons were used in the distal aorta.Post angiogram showed both limbs patent with good flow bilateral and the patient had good pulses bilaterally post procedure films review summary: the exact cause of the reported right limb occlusion could not be determined from the pre-implant films provided.Films at implant and post-implant ct¿s were not provided, and the in-vivo configuration of the implanted stent grafts and the reported occlusion event could not be assessed.Review of a pre-implant 3d/ct film report revealed that the patient had a proximal neck that ranged in diameter from 20 ¿ 21mm along a 3cm length neck that was essentially straight and free from calcification and thrombus.The distal aortic diameter measured 21mm with calcification noted.The right common iliac artery was non-tortuous, measuring from 10 ¿ 11.5mm in diameter, and the right external iliac artery measured 10mm in diameter near its origin.It is possible that this occlusion event was anatomy related; implanting within a small calcified distal aorta that may have compressed the right limb, leading to thrombus formation.Other possible occlusion contributors (which are currently unknown) include verification of the diameter of the implanted contra limb(s) and possible ipsi limb extension, amount of limb/vessel oversizing, assessment of the limb flow lumen along the entire length, location of any overlapping limbs, and if the right limb may have been extended into the right external iliac artery.This occlusion may also have been caused by a patient condition: poor distal runoff, an unknown coagulopathy that is now presenting, or a previous history of pad.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: 7569232
• Report Number: 2953200-2018-00809
• Device Sequence Number: 1758775
• Product Code: MIH
• UDI-Device Identifier: 00613994991249
• UDI-Public: 00613994991249
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 06/27/2018

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: 03/09/2019
• Device Model Number: ETBF2513C166E
• Device Catalogue Number: ETBF2513C166E
• Device Lot Number: V07348080
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/15/2018
• Initial Date Received by Manufacturer: 05/14/2018
• Supplement Date Received by Manufacturer: 06/05/2018
• Initial Report FDA Received Date: 06/05/2018
• Supplement Report FDA Received Date: 06/27/2018
• 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: 70 YR