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

Model Number	ENBF3216C166E
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Injury (2348)
Date of Event	06/21/2017
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 stent graft system was implanted in a patient for the endovascular treatment of a 61 mm abdominal aortic aneurysm.It was reported that during a routine follow up ct a type ia endoleak was observed.The patient was presented for treatment of the endoleak.An endurant ii cuff was implanted proximal to the original bifurcated stent graft but upon trying to remove the delivery system in the angled neck it got caught on the supra renal fixation.This resulted in the cuff being pulled to the same level as the originally placed bifurcated endurant stent graft.A second endurant cuff and 6 aptus endoanchors were then placed and extra care was taken in removal of the delivery system.This resolved the type ia endoleak.According to the physician, the cause of the event was anatomy related, due to angulated neck anatomy and disease progression.No additional clinical sequelae were reported and the patient is fine.
Additional Manufacturer Narrative
Films review summary: the exact cause of the proximal type i endoleak could not be determined from the films provided.The anatomy at implant is unknown, and images during implant and the intervention were not available.A ct-3d film report from 4 months post-implant confirmed that the bifurcate was positioned ~5mm below the renal arteries within the neck which was angulated ~60 deg a-p.The suprarenal neck diameter just below the sma measured 23mm, 14mm lower near the level of the renals was 30mm in diameter, and 5mm below the renals measured 33mm in diameter.It is possible that disease progression (neck dilatation) and neck angulation may have contributed to the type ia endoleak.It is also possible that the unfavorable neck anatomy, including the small suprarenal neck diameter, may have contributed to the aortic cuff removal difficulties during the intervention.This may have also been user related.If information is provided in the future, a supplemental report will be issued.

• Brand Name: ENDURANT 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: 6995669
• Report Number: 2953200-2017-01686
• Device Sequence Number: 1006510
• Product Code: MIH
• UDI-Device Identifier: 00613994762429
• UDI-Public: 00613994762429
• 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
• Device Implanted Year: 2012
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/28/2017

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: 11/24/2013
• Device Model Number: ENBF3216C166E
• Device Catalogue Number: ENBF3216C166E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/10/2017
• Initial Date Received by Manufacturer: 10/05/2017
• Supplement Date Received by Manufacturer: 11/08/2017
• Initial Report FDA Received Date: 11/02/2017
• Supplement Report FDA Received Date: 11/28/2017
• 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: 84 YR
• Patient Weight: 65