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

Model Number	ETLW1624C156E
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Injury (2348)
Date of Event	03/15/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 an unknown size abdominal aortic aneurysm.It was reported that a type ib endoleak was identified on a ct exam performed approximately 3 years post index procedure.The patient's iliac artery distal to the stent graft ranged in diameter from 27.3mm-29.4mm.Intervention was carried out to resolve the leak during which, the left hypogastric artery was plugged and a 16x20x199 limb extension was implanted.As per the physician, the cause of the event was anatomy related due to further iliac artery dilation no additional clinical sequelae were reported and the patient is fine.
Additional Manufacturer Narrative
Films review summary: the exact cause of the reported type ib endoleak could not be determined from the films provided.The pre-implant anatomy is unknown, and earlier post-implant films and the most recent complete ct's were not available for review.A 3d-ct film report from 31-months post-implant revealed that the bifurcate was positioned just below the renal arteries, and the bifurcate aortic body and infrarenal neck were essentially straight.The flared contra limb was seen positioned down into the left common iliac artery ~3cm above the left internal iliac bifurcation.Possible contrast was seen around the distal left limb; however, no clear contrast was seen within the aaa sac as images within the aaa were not seen in the films provided.Just distal to the stent graft the left common iliac artery ranged in diameter from 29 ¿ 27mm.The proximal portion of the left external ranged in diameter from 15 ¿ 16 ¿ 18mm, and mid-length of the left external iliac was noted as severely tortuous.The devices were patent.Images during the intervention were not provided.It is possible that disease progression with continued iliac artery dilatation may have contributed to the reported type ib endoleak.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: 7432010
• Report Number: 2953200-2018-00542
• Device Sequence Number: 11170229
• Product Code: MIH
• UDI-Device Identifier: 00643169467491
• UDI-Public: 00643169467491
• 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: 2015
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/25/2018

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: 02/23/2017
• Device Model Number: ETLW1624C156E
• Device Catalogue Number: ETLW1624C156E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2018
• Initial Date Received by Manufacturer: 03/19/2018
• Supplement Date Received by Manufacturer: 05/03/2018
• Initial Report FDA Received Date: 04/16/2018
• Supplement Report FDA Received Date: 05/25/2018
• 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