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	11/01/2017
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 67 mm diameter abdominal aortic aneurysm.It was reported that on follow up cta performed approximately 6 years post index procedure, a type ia endoleak was identified.The patient was noted to be asymptomatic and was scheduled for routine secondary repair.During this endovascular procedure, coils, onyx, a cuff and heli-fx endoanchors were used to resolve the endoleak.As per the physician, the cause of the event cannot be determined.No additional clinical sequelae were reported and the patient is fine.
Additional Manufacturer Narrative
Films review summary: the cause of the type i a endoleak could not be determined from the limited films provided.The anatomy at implant and earlier follow-up films were not available, and complete ct¿s were not available for a more comprehensive assessment.The proximal neck was conical-shaped, ranging in diameter from 25 ¿ 31mm along the 10mm of proximal neck length.It is possible that a marginal seal from this conical neck may have contributed to the type ia endoleak.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: 7066187
• Report Number: 2953200-2017-01886
• Device Sequence Number: 1300558
• Product Code: MIH
• UDI-Device Identifier: 00613994762429
• UDI-Public: 00613994762429
• 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: 2011
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/04/2018

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: 10/02/2013
• Device Model Number: ENBF3216C166E
• Device Catalogue Number: ENBF3216C166E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/10/2017
• Initial Date Received by Manufacturer: 11/09/2017
• Supplement Date Received by Manufacturer: 12/13/2017
• Initial Report FDA Received Date: 11/29/2017
• Supplement Report FDA Received Date: 01/04/2018
• 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
• Patient Weight: 74