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	No Consequences Or Impact To Patient (2199)
Date of Event	07/08/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Film analysis summary: the reported bilateral limb migration leading to the distal type i endoleak and aaa expansion 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.It was reported that the iliac arteries were ectatic at implant.Therefore, it appears likely that continued disease progression (distal aortic and bilateral iliac artery dilatation) may have led do the limb migration and resulting events.It is also possible that aneurysm morphology changes, as evidenced by the severely angulated neck, may have also contributed to the migration.Although no clear endoleak is seen proximally, there also appears to have been disease progression of the proximal neck, with likely neck dilation <(>&<)> neck length shortening, and a potential increase in the neck angulation.Other relevant device(s) are: product id: etlw1628c124e, serial/lot #: (b)(4), ubd: 26-sep-2018, udi #: (b)(4).If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
An endurant iis stent graft system was implanted in a patient for the endovascular treatment of a 70 m abdominal aortic aneurysm.A follow up ct approximately two years later showed the bilateral limbs pulled up into the aneurysm and a severe type ib endoleak.As per the physician, the cause of the event was patient anatomy.It was reported that the iliacs were ectatic at the time of implant.No additional clinical sequelae were reported and the patient is being 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: 8836307
• Report Number: 9612164-2019-03087
• Device Sequence Number: 11396586
• Product Code: MIH
• UDI-Device Identifier: 00643169467453
• UDI-Public: 00643169467453
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P100021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/29/2018
• Device Model Number: ETLW1628C124E
• Device Catalogue Number: ETLW1628C124E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/11/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/11/2019
• Initial Report FDA Received Date: 07/29/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 79 YR