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

Catalog Number ETBF3220C166EE

Device Problem No Apparent Adverse Event (3189)

Patient Problems Death (1802); Unspecified Infection (1930)

Event Date 12/27/2014

Event Type  Death  

Event Description

An endurant stent graft system was implanted in a patient for the endovascular treatment of an abdominal aortic aneurysm.It was reported one month post implant there was swelling visible on a ct which also showed a compression of the aortic wall and this was in retrospect was described as the beginning of a post-operative complication / infection.Additional this may have occurred at the primary surgery (smear: enterococci) and it is also possible the prosthesis itself was a source of infection.The patient died due to the infected aneurysm with spondylodiscitis as well as entreococcen bacteria.The physician is not sure that the prosthesis by itself is the source of the bacterial contamination.The physician stated the event was related to the device and procedure.Review of cta¿s from 4 days post-implant revealed that the endurant bifurcate was currently positioned just below the renal arteries.The ipsilateral limb was placed down into the right common iliac artery, and the contralateral limb into the left common iliac.The proximal stent graft od measured 25mm just below the renal arteries.The maximum diameter aaa measured 5.5cm.There was contrast feeding the sac from the ima; no stent graft endoleak was observed.Both limbs were patent.Review of cta¿s from 11 days post-implant showed the stent graft positioned just below the renal arteries.The maximum diameter aaa was stable at 5.5cm.Contrast is again seen in the anterior sac from retrograde flow from the ima, and there is also possible inflow from a posterior lumbar near the top of the sac.Both limbs are patent and no other stent graft issues are seen.Review of cta¿s from 5 months post-implant revealed that the stent graft was in the approximate same in-vivo configuration as the earlier studies.There is no evidence of any endoleak.However the shape of the aaa has a different appearance from the previous studies.The maximum diameter is approximately 5cm.The aneurysm wall appears to have thickened which may be an inflammatory response, and there are air bubbles visible within the sac which may indicate an infection.The origin of the reported infection could not be determined from the films returned.It is possible that the infection could have originated from the implanted stent graft.Alternatively, this could have been the result from a systemic infection that seeded and proliferated on the stent graft material and aaa.

Manufacturer Narrative

(b)(4).

• Brand Name: ENDURANT II
• Type of Device: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• Manufacturer (Section G): MEDTRONIC CARDIOVASCULAR; 3576 unocal place; santa rosa CA 95403
• Manufacturer Contact: eric elliott ; 3576 unocal place; santa rosa, CA 95403 ; 7075912586
• MDR Report Key: 4466795
• MDR Text Key: 21773087
• Report Number: 2953200-2015-00175
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P100021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/03/2015

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
• Device Operator: Health Professional
• Device Expiration Date: 05/25/2016
• Device Catalogue Number: ETBF3220C166EE
• Device Lot Number: V04659891
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/03/2015
• Initial Date FDA Received: 01/29/2015
• Date Device Manufactured: 05/26/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 00078 YR