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

Model Number	ETLW1620C124E
Medical Device Problem Codes	Leak/Splash (1354); Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	Injury (2348)
Date of Event	01/26/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Section d information references the main component of the system.Other relevant device(s) are: (enter (b)(4) number, serial number (b)(4), use by date (b)(6) 2014 and upn# (b)(4)).Film evaluation summary; the exact cause of the bilateral limb migration could not be determined from the films provided.The anatomy at implant is unknown, earlier post-implant films were not available as the patient was lost to follow-ups, and additional images during the intervention were also not provided.Review of a 3d-ct film report from 5+ years post-implant (first patient follow-up since implant) confirmed that the right limb was tortuous and crossed over the left limb, and both limbs appeared to have pulled out of the aneurysmal iliac arteries.A likely distal type i endoleak was seen on the right side.Along the essentially straight 46mm length section between the distal right iliac limb and the right hypogastric the rcia diameter ranged from 19 ¿ 12mm.Along the acutely angulated 36mm length section between the distal left iliac limb and the left hypogastric the rcia diameter ranged from 23 ¿ 18mm.Two (2) returned still angiograms during an intervention ( (b)(6) 2018) confirmed that both migrated limbs had been treated by extending down to just short of the hypogastric arteries; bilaterally.It is possible that disease progression (iliac artery dilatation) and aneurysm morphology changes (vessel angulation) may have contributed to the bilateral limb migration.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 56mm diameter abdominal aortic aneurysm.It was reported that when the patient returned for follow up ct that both limbs had migrated into the aneurysmal sac leading to bilateral type ib endoleaks in the bifurcate and limb.The physician completed intervention with a 16x24x124 limb that was extended down to the proximal half of the rcia with good seal noted.A second 16x16x124 limb was then telescoped through that and sealed in the distal half of the rcia.A 16x24x124 limb was implanted down to the left hypogastric artery with good seal observed.As per the physician, the cause of the event cannot be determined.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: 7285206
• Report Number: 2953200-2018-00264
• Device Sequence Number: 11065316
• Product Code: MIH
• UDI-Device Identifier: 00613994991645
• UDI-Public: 00613994991645
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• PMA/510(K) Number: P100021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/21/2018

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: 09/21/2014
• Device Model Number: ETLW1620C124E
• Device Catalogue Number: ETLW1620C124E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/26/2018
• Initial Report FDA Received Date: 02/21/2018
• 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: 76 YR