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

Model Number	ETBF2513C145E
Medical Device Problem Code	Occlusion Within Device (1423)
Health Effect - Clinical Codes	Occlusion (1984); Pain (1994)
Date of Event	10/05/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Information references the main component of the system.Other relevant devices are: etew2020c82e , s/n: (b)(4); use by date: 14-oct-2015; upn # (b)(4); tlw1616c82e , s/n: (b)(4); use by date:28-aug-2015; upn # (b)(4); etlw1616c124e , s/n: (b)(4); use by date:16-dec-2015; upn # (b)(4); etlw1620c124e , s/n: (b)(4); use by date:16-sep-2015; upn # (b)(4).
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.It was reported that during a follow up ct performed approximately 3.5 years post index procedure, occlusion of the right limb of the stent graft was observed.It was stated that the patient had reported pain in his right leg from approximately 3 years post index procedure which the physician states to be likely related.As per the physician, the cause of the event is related to angulation of the aorta, causing thrombosis of the limb to occur.It was reported that there was no intervention performed at time of event.No additional clinical sequelae were reported and the patient is being monitored by their physician.
Additional Manufacturer Narrative
Films review summary: the exact cause of the limb occlusion could not be determined from the films provided.However, it appears likely that aortic neck angulation contributed to this event.Review of ct¿s from 43 months post-implant revealed that the bifurcate was positioned just below the renals within the severely angulated neck.Although the aortic body was straight, the bifurcate was angulated beginning at the flow divider ~100 a-p relative to the iliac limbs.The right/ipsi limb and 2 right limb extensions were 100 % occluded beginning just below the bifurcate flow divider, near to where the ipsi limb was acutely angulated and slightly compressed along the anterior of the aaa sac.This occlusion was a likely consequence of this severe neck/stent graft angulation which was possibly caused by disease progression and aneurysm morphology changes.No endoleak was observed.However, a near limb separation (<(><<)>(> <(><<)><(><<)>)> 10mm of overlap with junctional angulation) was seen between the occluded bifurcate ipsi limb and right limb extension within the unsupported aaa sac, which may have been the source of an previous type iii junctional endoleak prior to the right limbs occluding.The cause of the suspected limb detachment is unknown, but likely also related to the aortic remodeling.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: 7012510
• Report Number: 2953200-2017-01724
• Device Sequence Number: 800052
• Product Code: MIH
• UDI-Device Identifier: 00613994991232
• UDI-Public: 00613994991232
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P100021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/04/2017

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: 05/07/2015
• Device Model Number: ETBF2513C145E
• Device Catalogue Number: ETBF2513C145E
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/17/2017
• Supplement Date Received by Manufacturer: 11/15/2017
• Initial Report FDA Received Date: 11/09/2017
• Supplement Report FDA Received Date: 12/04/2017
• 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: Other
• Patient Age: 70 YR