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

Model Number	ETLW1613C93E
Medical Device Problem Codes	Leak/Splash (1354); Occlusion Within Device (1423)
Health Effect - Clinical Codes	Occlusion (1984); Rupture (2208)
Date of Event	09/09/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Other relevant device(s) are: catalog # etlw1616c82e, serial # (b)(4), use by date: 2017-12-09, manufactured date: 2015-12-10, and upn# (b)(4).Catalog # etlw1624c156e, serial # (b)(4), use by date: 2017-08-26, manufactured date: 2015-08-27, and upn# (b)(4).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 an abdominal aortic aneurysm.It was reported that the patient presented emergently.The non-contrasted ct demonstrated a thoracoabdominal aneurysm that had progressed below the renal arteries.There was no visual evidence of endoleaks since there was no contrast with the ct scan.There was an endurant bifurcated graft with aptus endoanchors in addition to the iliac limbs implanted.The physician elected to explant the stent graft.It was reported during the explant procedure, that there was no apparent rupture proximally and the suprarenal anchor pins remained engaged in the aorta and the proximal seal zone of the stent graft appeared to be sitting in thrombus.The left iliac limb was occluded but the iliac was patent and a distal type i endoleak that was back bleeding in to the aneurysm sac, resulting in aneurysm rupture.There was also some liquified thrombus outside of the aneurysm in this area where the likely aneurysm rupture occurred, most likely a contained rupture.The conversion to an open surgical repair was successful.Per the physician, the cause of the contained rupture was due to the tortuosity of the left common iliac artery causing the occlusion and following rupture.No additional clinical sequelae were reported and the patient is fine.

• 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: 6907582
• Report Number: 2953200-2017-01541
• Device Sequence Number: 1208298
• Product Code: MIH
• UDI-Device Identifier: 00643169467682
• UDI-Public: 00643169467682
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: P100021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/09/2017

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: 01/24/2018
• Device Model Number: ETLW1613C93E
• Device Catalogue Number: ETLW1613C93E
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/09/2017
• Initial 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
• Patient Age: 65 YR