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

Model Number	ETLW1620C124E
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/17/2017
Type of Reportable Event	Malfunction
Event or Problem Description
An endurant ii stent graft system was implanted in a patient for the endovascular treatment of an abdominal aortic aneurysm of unknown size.It was reported that the patient for follow up ct, on which a type ib endoleak originating from the left common iliac artery was observed by the physician.This endoleak was confirmed on angiogram.Intervention was performed to resolve the event by using coils to embolize the left hypogastric artery and an endurant limb was used to build onto the left external iliac.Final angiogram showed that this procedure resolved the type ib endoleak on the left side but there was now observed a leak on the right side.The physician decided to stop the procedure at this stage and discuss next steps with the patient because as they didn't want to embolize both hypo gastric arteries in the same surgery.The type ib endoleak remains on the right side.As per the physician, the cause of the event is anatomy related due to disease progression in both common iliac arteries.No additional clinical sequelae were reported and the patient is fine.
Additional Manufacturer Narrative
Films review summary: the exact cause of the bilateral distal type ib endoleak could not be determined from the limited films provided.The anatomy at implant is unknown, earlier patient follow-up films were not available, and more complete current ct¿s were not provided.Two still ct images from an unknown study date revealed that the aaa sac appeared to extend distally near the termination of both iliac limbs, as there was lack of stent graft apposition surrounding the distal od of the right and left limbs.A potential distal type ib was seen bilaterally.No scale was seen on the films; therefore, no stent graft or vessel measurements could be performed.A single non-contrast angiogram during an intervention showed that an endurant limb had been implanted into the left/contra limb, extending distally into the left external iliac artery.Since the films were non-contrast no assessment of any endoleak (on either side) could be performed.It is possible that disease progression with iliac artery dilatation contributed to the distal type i endoleak(s).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: 7016870
• Report Number: 2953200-2017-01729
• Device Sequence Number: 18863748
• Product Code: MIH
• UDI-Device Identifier: 00613994991645
• UDI-Public: 00613994991645
• 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
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/04/2017

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: 09/21/2016
• Device Model Number: ETLW1620C124E
• Device Catalogue Number: ETLW1620C124E
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/18/2017
• Supplement Date Received by Manufacturer: 11/14/2017
• Initial Report FDA Received Date: 11/10/2017
• Supplement Report FDA Received Date: 12/04/2017
• 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: 74 YR