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

Model Number	ETLW1613C93E
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); Injury (2348)
Date of Event	11/03/2017
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 a 67mm diameter abdominal aortic aneurysm.It was reported that approximately 3 months post index procedure, on follow up ct, the physician was concerned about the possible presence of a type ia endoleak.A type ib endoleak was suspected within (b)(4).As per the physician, the cause of the event is due to anatomy as the infrarenal aorta and right common iliac appear to have dilated since the initial implant of the stent grafts.No additional clinical sequelae were reported and the patient will be monitored by the physician.
Additional Manufacturer Narrative
Additional information was received reported that an angiogram was performed.An endurant ii cuff (28x28x70) was implanted along with a non-medtronic stent into the left renal.The physician confirmed the endoleak has resolved and the patient is fine.It was reported that 2 non-medtronic stents were implanted, one in the internal iliac and one in the external iliac.This resolved the type ib leak, according to the physician.No additional clinical sequelae were reported, and the patient is fine.Internal film review: the exact cause of the reported endoleaks could not be determined from the films provided.The pre-implant anatomy is unknown, and films during implant were not available for review.Ct¿s from 3 months post-implant revealed that the bifurcate was positioned ~5mm below the lowest left renal.The aortic body and infrarenal neck were essentially straight and no appreciable calcification was seen within the neck.However, there appeared to be inadequate stent graft radial apposition of the bifurcate with the proximal neck, and a likely proximal type i endoleak was visible.The neck diameter just below the left renal measured ~26mm, the bifurcate proximal od measured 29mm, and the neck diameter at that same level measured 33mm.Contrast was also seen outside the distal right/contra limb which was not in contact with the iliac artery and measured 17mm in diameter.There was contrast seen within the distal aaa sac, possibly from a distal type ib on the right side, however the contrast was continuous with the proximal type i endoleak contrast and therefore a type ib (or an additional endoleak of unknown source) could not be confirmed.The cause of the proximal type i and potential type ib was likely due to disease progression; proximal neck and iliac dilatation.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: 7066179
• Report Number: 2953200-2017-01881
• Device Sequence Number: 16563353
• Product Code: MIH
• UDI-Device Identifier: 00613994991539
• UDI-Public: 00613994991539
• Combination Product (Y/N): N
• Initial Reporter State: UT
• 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): 12/21/2017

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: 04/02/2016
• Device Model Number: ETLW1613C93E
• Device Catalogue Number: ETLW1613C93E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/09/2017
• Initial Date Received by Manufacturer: 11/09/2017
• Supplement Date Received by Manufacturer: 12/05/2017
• Initial Report FDA Received Date: 11/29/2017
• Supplement Report FDA Received Date: 12/21/2017
• 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: 78 YR