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

Model Number	ETLW1628C124E
Medical Device Problem Codes	Leak/Splash (1354); Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	Injury (2348)
Date of Event	01/11/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
An endurant ii stent graft system was implanted in a patient for the endovascular treatment of a 64 cm abdominal aortic aneurysm.It was reported that there was a type ia endoleak on the left proximal side and the graft was down 15mm.It was also reported that the right limb did not have purchase and there was 35mm before the internal iliac take off.The right limb was determined to have migrated and the right stent graft limb was observed to have a distal type i endoleak.Per the physician, the cause of the proximal type i endoleak was due to the patient anatomy of proximal aortic neck angulation.Per the physician, the cause of the distal type i endoleak and migration of the right limb was due to dilation of the right common iliac artery that was aneurysmal and had a short purchase flare.The physician elected to implant a right iliac stent graft that extended to the right hypogastric artery and the distal type i endoleak was resolved.The physician then elected to implant an aortic cuff.However, the aortic cuff was deployed too low due to being deployed without a parallax correction.The physician elected to deploy an additional aortic cuff proximally but the second aortic cuff was deployed too high.The second aortic cuff completely covered the left renal artery and partially covered the right renal artery.Per the physician, the cause of the second inaccurate delivery was due to user error.The physician was unable to successfully deploy a right renal stent using a brachial approach and so elected to complete the procedure without implanting a right renal stent.No additional clinical sequelae were reported and the patient is fine.
Additional Manufacturer Narrative
Corrected information: sex, date of birth.If information is provided in the future, a supplemental report will be issued.

• 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: 6306038
• Report Number: 2953200-2017-00159
• Device Sequence Number: 10890845
• Product Code: MIH
• UDI-Device Identifier: 00643169467453
• UDI-Public: 00643169467453
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: P100021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/23/2017

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: 03/12/2017
• Device Model Number: ETLW1628C124E
• Device Catalogue Number: ETLW1628C124E
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/23/2017
• Supplement Date Received by Manufacturer: 01/23/2017
• Initial Report FDA Received Date: 02/06/2017
• Supplement Report FDA Received Date: 09/29/2017
• 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: 82 YR