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

Model Number	ETLW1620C82E
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); Injury (2348)
Date of Event	04/02/2018
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 on ct exam revealed a type ia and type ib endoleak on the right side.As per the physician, the cause of the event is related to loss of seal.No additional clinical sequelae were reported and the patient will be monitored.
Additional Manufacturer Narrative
Additional information received: it was reported that intervention to treat the type ia and ib endoleak was completed.Two aortic cuffs were implanted just below the left renal artery, while telescoping into the endurant main body.Endoanchors were implanted prophylactically due to the wide angulated neck at the proximal end of the most proximal cuff.The right internal iliac artery was embolised and a limb extension was implanted to treat the internal iliac aneurysm and the type ib endoleak.Ballooning was carried out and the final angiogram showed no sign of endoleak and a good flow through the stent grafts.Film evaluation summary: the likely cause of the proximal and distal type i endoleaks leading to the aneurysm expansion appears to have been due to disease progression.Pre-implant ct¿s revealed that the patient had a 5cm diameter x 6cm length aaa located near the distal aorta, beginning ~7cm below the lowest right renal artery.The flow lumen diameter just below the lowest right renal artery measured ~22 ¿ 23mm, and the infrarenal neck was moderately angulated ~60 deg maximum rt-lt.The right common iliac artery ranged in diameter from ~16 ¿ 17mm, the left common iliac artery ranged in diameter from ~20 ¿ 15 ¿ 18mm, and the left internal iliac artery was aneurysmal; measuring 3cm in diameter.Ct¿s from 18 & 60 months post-implant revealed that there had been continued proximal neck diameter expansion to ~43mm near the bifurcate proximal margin with potential migration, leading to a proximal type i endoleak and aaa expansion to 7cm in diameter.Disease progression also appeared to have occurred distally extending into the right common iliac artery where the distal end of the 21mm od contra limb had pulled out of the right common iliac artery which had increased to ~28mm in diameter.The patient also had an aneurysmal right internal iliac artery which was ~3cm in diameter.In addition to disease progression (vessel dilatation), aneurysm morphology changes as seen from increase neck angulation may have also contributed to the events.Images during the intervention which resolved the events were not available for review.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: 7493735
• Report Number: 2953200-2018-00656
• Device Sequence Number: 1339168
• Product Code: MIH
• UDI-Device Identifier: 00613994991621
• UDI-Public: 00613994991621
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: P100021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/29/2018

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: 01/24/2015
• Device Model Number: ETLW1620C82E
• Device Catalogue Number: ETLW1620C82E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/19/2018
• Initial Date Received by Manufacturer: 04/11/2018
• Supplement Date Received by Manufacturer: 05/07/2018
• Initial Report FDA Received Date: 05/08/2018
• Supplement Report FDA Received Date: 05/29/2018
• 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: 82 YR