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

Model Number	ETLW1624C156E
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Codes	Injury (2348); No Code Available (3191)
Date of Event	07/13/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Film evaluation summary: the exact cause of the type ib endoleak leading to the aaa enlargement could not be determined from the films provided.The anatomy at implant is unknown, the amount of initial right limb overlap into the common iliac artery is unknown, and earlier post-implant films were not available for comparison.Review of a 3d-ct film report from 41 months post-implant confirmed a likely distal type i endoleak from the right limb appeared to have pulled out of the aneurysmal right common iliac artery.The bifurcate ipsi limb on the right side had been extended with two (2) endurant limbs, and the limbs were angulated as they coursed distally down the right side; the infrarenal neck and bifurcate aortic body were angulated ~90 deg a-p relative to the iliac limbs.The distal right limb near the bottom of the aaa sac measured ~26mm in diameter and appeared fully expanded and unopposed to the vessel.Distal to the limb the rcia was calcified and ranged in diameter from 30 ¿ 26 ¿ 20 ¿ 16mm along the 5cm uncovered length down to the right internal iliac artery bifurcation.It is possible that disease progression (vessel dilatation) and aneurysm morphology changes may have contributed to the limb migration and resulting type ib endoleak and aaa expansion.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 91mm diameter abdominal aortic aneurysm.It was reported that during a follow up ct scan approximately 2 years post the index procedure a type ib endoleak was noted with aneurysmal sac enlargement.The patient received intervention; the riia and feeder vessels were occluded using coils and plugs.An endurant limb was placed at the level of the flow divider and extended down in to the reia and another endurant limb was used to extend further down the reia.This resolved the event.Per the physician, the cause of the event was due to the patients¿ anatomy, with a continued dilation of the rcia causing the limb to have loss of seal and to have pulled up into the sac causing a type ib endoleak no additional clinical sequelae were reported, and the patient is fine.
Additional Manufacturer Narrative
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: 7747014
• Report Number: 2953200-2018-01132
• Device Sequence Number: 1319042
• Product Code: MIH
• UDI-Device Identifier: 00643169467491
• UDI-Public: 00643169467491
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P100021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/03/2018

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: 11/16/2016
• Device Model Number: ETLW1624C156E
• Device Catalogue Number: ETLW1624C156E
• Device Lot Number: V05973013
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2018
• Initial Date Received by Manufacturer: 07/13/2018
• Supplement Date Received by Manufacturer: 08/08/2018
• Initial Report FDA Received Date: 08/03/2018
• Supplement Report FDA Received Date: 10/03/2018
• 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: 84 YR
• Patient Weight: 109