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

Model Number	ETBF2313C145E
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Injury (2348)
Date of Event	10/13/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Film evaluation summary: the reported proximal type i endoleak was confirmed; contrast was seen at the proximal aneurysm sac along the right side of the stent graft.The exact cause could not be conclusively determined from the films provided.Films at implant, and earlier post-implant films were not provided.The bifurcate location at implant was unknown.However, there appears to be disease progression, aortic neck dilatation, at the proximal bifurcate margin since implant leading to inadequate seal at the proximal bifurcate margin.In addition, the proximal aortic neck body was highly angulated (>60 degs), and the aortic neck diameter where the suprarenal stent was positioned was narrow (~ 10 mm).It is possible that disease progression (aortic neck dilatation) combined with highly angulated aortic neck may have contributed to event.The small aortic neck diameter where the suprarenal stent was positioned may have prevented the bifurcate proximal margin to expand to its full diameter, which may have also contributed to the event.Continued from block off-label, unapproved or contraindicated use (aortic neck angulation).
Event or Problem Description
An endurant ii stent graft system was implanted in a patient for the endovascular treatment of an abdominal aortic aneurysm.Morphology at implant is unknown; however, at the time of the intervention the neck angulation was 79 degrees.Tortuosity was noted as moderate and calcification was mild.It was reported that a follow up ct revealed a type ia endoleak.It was noted that the device appeared to be placed 3cm below the lowest main renal artery, however, it was noted that the graft was just below an accessory renal artery which provided a large portion of blood flow to the right kidney.A 25x25x70 endurant ii aortic extension was implanted and the lowest accessory renal was intentionally covered.This resolved the event.The physician stated that the cause of the event could not be determined.No additional clinical sequelae were reported and the patient is fine.
Additional Manufacturer Narrative
Corrected information: sex, date of birth.If information is provided in the future, a supplemental report will be issued.

• 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: 6181403
• Report Number: 2953200-2016-02131
• Device Sequence Number: 11011353
• Product Code: MIH
• UDI-Device Identifier: 00613994991171
• UDI-Public: 00613994991171
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 11/30/2016

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: 12/15/2016
• Device Model Number: ETBF2313C145E
• Device Catalogue Number: ETBF2313C145E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2016
• Initial Date Received by Manufacturer: 11/30/2016
• Supplement Date Received by Manufacturer: 11/30/2016
• Initial Report FDA Received Date: 12/16/2016
• Supplement Report FDA Received Date: 09/27/2017
• 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: 70 YR