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

Model Number	ETLW1620C124E
Medical Device Problem Code	Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Codes	Pain (1994); Injury (2348)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Continuation of medical devices: information references the main component of the system.Other relevant device(s) are: product id: etlw1613c93e, serial/lot #: (b)(4), ubd: 05-nov-2014, udi#: (b)(4); product id: etbf3216c145e, serial/lot #: (b)(4), ubd: 31-oct-2015, udi#: (b)(4).Film evaluation summary: the reported bilateral limb kinking <(><<)>(><(>&<)><(><<)>)> angulation below the level of the flow divider was confirmed.However, the exact cause could not be determined from the films provided.The anatomy at implant is unknown, and earlier post-implant films were not provided for comparison.Ct¿s returned from 58 months post-implant revealed that an endurant cuff was seen positioned just below the lowest left renal artery, and ~10mm lower near the top of the aaa sac the proximal fabric of the endurant bifurcate was seen overlapping the cuff.There was ~10mm of remaining proximal seal length; however, no clear endoleak was seen within the 45mm diameter aaa either proximally or distally.The infrarenal neck was angulated at the flow divider ~65 deg a-p x 40 deg rt-lt; relative to the iliac limbs.The cuff/bifurcate aortic body were essentially straight; however, there was substantial acute limb angula tion observed near the level of the bifurcate flow divider.The origin of both the ipsilateral and contra limb were acutely angulated ~60 deg and 80 deg (respectively) at the bifurcate flow divider.The angulation occurred at the anterior-right side of the aaa, and resulted in a slight compression of each limb to a minimum flow lumen diameter of ~12mm (ipsi) and 9mm (contra).However, the stent grafts were patent with no appreciable thrombus, and no flow obstruction was observed distal to the limbs; bilaterally.It is possible that neck angulation and aneurysm morphology changes during the implant duration may have led to the observed acute limb angulation and resulting bilateral limb compression.However, the returned films do not show any obvious thrombus/occlusion which has occurred within or distal to the stent grafts, as a result of this bilateral stent graft compression.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 63mm diameter abdominal aortic aneurysm.It was reported that on an unknown date during the patient presented emergently with leg pain.Kinking of the stent graft was noted distal to the flow divider.The patient received multiple fasciotomies to relieve tension in addition to tpa.Per the physician, shrinking of the aneurysm (from 63mm to 46mm) has contributed overall to causing this event.No additional clinical sequelae were reported and the patient will be monitored.

• 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: 8099473
• Report Number: 2953200-2018-01610
• Device Sequence Number: 19299495
• Product Code: MIH
• UDI-Device Identifier: 00613994991645
• UDI-Public: 00613994991645
• 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: 2013
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/23/2018

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: 09/19/2015
• Device Model Number: ETLW1620C124E
• Device Catalogue Number: ETLW1620C124E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/25/2018
• Initial Report FDA Received Date: 11/23/2018
• 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