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

Model Number	ETBF2513C166E
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Codes	Unspecified Infection (1930); Pain (1994)
Date of Event	06/02/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Info references the main component of the system.Other relevant device(s) are: etlw1613c124e sn (b)(4), expiration date: 2015-05-14, udi # (b)(4).
Event or Problem Description
An endurant ii stent graft system was implanted in a patient for the endovascular treatment an abdominal aortic aneurysm.It was reported that the patient had multiple bowel surgeries performed and also had extensive dental procedures.The patient presented with abdominal pain.A ct revealed that the abdominal aortic aneurysm appeared to the inflammatory.The physician had the radiologist percutaneous obtain a blood culture from the aaa sac, which was positive for various microbes.The patient received a pic-line to treat the infection/microbs.The patient returned six weeks later for a follow up ct which revealed an unknown endoleak.The physician performed an ax-bi-fem to bypass the infected aaa, and scheduled explanting at of the endurant stent graft the following day.The physician explanted the stent graft.Upon explant the physician noted that the unknown endoleak was a type iii fabric endoleak caused during the percutaneous stick to obtain the blood culture.The physician does not know the exact cause of the event however the infection was most likely related to the patient¿s anatomy; either the bowel surgeries or the dental procedures.No additional clinical sequelae were reported and the patient is fine.
Additional Manufacturer Narrative
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: 6672171
• Report Number: 2953200-2017-01041
• Device Sequence Number: 1115476
• Product Code: MIH
• UDI-Device Identifier: 00613994991249
• UDI-Public: 00613994991249
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: P100021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/05/2017

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: 09/04/2015
• Device Model Number: ETBF2513C166E
• Device Catalogue Number: ETBF2513C166E
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/05/2017
• Supplement Date Received by Manufacturer: 06/05/2017
• Initial Report FDA Received Date: 06/27/2017
• Supplement Report FDA Received Date: 10/04/2017
• 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: 86 YR