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

Model Number	ETBF2513C166E
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Occlusion (1984)
Date of Event	08/14/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Film evaluation summary: the cause of the aaa expansion appears to have been due to the migration of the right limb extension out of the right common iliac artery, which led to the distal type i endoleak.The timing and exact cause of the migration could not be determined.The anatomy at implant is unknown, and earlier post-implant films were not provide for comparison.It is possible that disease progression (iliac artery dilatation) and aneurysm morphology changes (as evidenced by the high limb angulation) may have led to the bilateral limb migration.The cause of the left side stent graft and vessel occlusion could not be determined.The limbs were gradually angulated ~80 deg; however, no stent graft kinks or compression was observed.It is possible that vessel tortuosity or the limb migration out of the lcia may have contributed.The occlusion may also have been caused by a patient condition: poor distal runoff, an unknown coagulopathy that is now presenting, or a previous history of pad.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 the patient presented emergently approximately two years and nine months later with a type ib endoleak and aneurysm expansion.A secondary procedure was carried out and the stent graft limbs extended bilaterally into the external iliac arteries to resolve the type ib endoleaks.As per film evaluation; the type ib endoleak was on the right ipsi limb and that this side was occluded as far as the bifurcation gate.The limb etlw1624c124e which was extended on the right and has migrated with a type ib endoleak and the contra limb on the left (etlw1620c156e) is 100 % occluded and also may have migrated although there was no endoleak evident.As per the physician, the cause of the event was due to the patient¿s anatomy.There was inadequate seal in the common iliac arteries causing the type ib endoleak.No additional clinical sequelae were reported and the patient is fine.

• Brand Name: ENDURANT II BIFURCATED STENT GRAFT
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• MDR Report Key: 9133528
• Report Number: 9612164-2019-04133
• Device Sequence Number: 11559636
• Product Code: MIH
• UDI-Device Identifier: 00613994991249
• UDI-Public: 00613994991249
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: P100021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/30/2019

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/13/2018
• Device Model Number: ETBF2513C166E
• Device Catalogue Number: ETBF2513C166E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/04/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/04/2019
• Initial Report FDA Received Date: 09/30/2019
• 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: 69 YR
• Patient Weight: 97