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

Model Number	ENBF2816C166E
Medical Device Problem Code	Occlusion Within Device (1423)
Health Effect - Clinical Codes	Unspecified Infection (1930); Occlusion (1984)
Date of Event	06/15/2012
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Other relevant device(s) are: enlw1616c124e sn (b)(4), expiration date: 2014-02-13, udi # (b)(4) a good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
An endurant stent graft and a heli-fx endoanchor system were implanted via percutaneous access in a patient for endovascular treatment of a 5.2 cm in diameter abdominal aortic aneurysm.The proximal aortic neck at the renal arteries 21 mm in diameter and 20 mm below the renal arteries 39 mm in diameter.The heli-fx device was implanted out of a concern for late failure.There is calcification in the proximal aorta.It was reported that the patient returned for follow up.The ct revealed that there was occlusion of the left iliac limb, which extended up to the bifurcated stent graft.The patient was given medication, however the event is continuing.The patient has a ct that revealed a type ii endoleak between ima <(>&<)> posterior lumbar branch.An inflammatory rind in the aneurysm was discovered, this resolved without treatment.The physician investigator could not determine a cause for the inflammatory rind, but it was assessed to be possibly related to the procedure.No additional clinical sequelae were reported and the patient will be monitored by the physician.
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 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: 6555469
• Report Number: 2953200-2017-00757
• Device Sequence Number: 226035
• Product Code: MIH
• UDI-Device Identifier: 00613994762481
• UDI-Public: 00613994762481
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 04/14/2017

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: 01/18/2014
• Device Model Number: ENBF2816C166E
• Device Catalogue Number: ENBF2816C166E
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/14/2017
• Supplement Date Received by Manufacturer: 04/14/2017
• Initial Report FDA Received Date: 05/09/2017
• Supplement Report FDA Received Date: 10/03/2017
• 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: 66 YR
• Patient Weight: 100