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

Model Number	ENBF3216C145E
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Injury (2348)
Date of Event	02/20/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 system was implanted in a patient for the endovascular treatment of an abdominal aortic aneurysm.It was reported that the patient returned for follow up, and that there was a proximal type i endoleak identified.An intervention was performed and a 32x32x49 cuff was placed.This reportedly resolved the endoleak.Per the physician, the cause of the proximal type i endoleak is related patient anatomy of aortic neck dilatation.No additional clinical sequelae were reported and the patient is fine.
Additional Manufacturer Narrative
Film evaluation summary: the exact cause of the proximal type i endoleak could not be conclusively determined from the post-implant 3d recon report provided.Pre-implant, films at implant, earlier post-implant films, and additional films at the time of the event were not provided for review and comparison.Anatomy information at the time of implant was unknown.Bifurcate location at implant was unknown.The 3d recon report provided showed that the bifurcate is positioned couple cm's below the renals.There appeared to be marginal proximal seal with minimal stent graft apposition to the aortic wall.Contrast was seen outside of the stent graft at the proximal aneurysm sac, from a possible proximal type i endoleak.Since the anatomy information at implant was not provided, it was unclear if there was disease progression.The 3d recon report showed that the aortic neck was severely angulated.The severely angulated aortic neck may have contributed to the proximal type i endoleak.
Additional Manufacturer Narrative
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: 6635819
• Report Number: 2953200-2017-00965
• Device Sequence Number: 13576978
• Product Code: MIH
• UDI-Device Identifier: 00613994762436
• UDI-Public: 00613994762436
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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,Followup
• Report Date (Section B): 06/16/2017

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: 09/26/2013
• Device Model Number: ENBF3216C145E
• Device Catalogue Number: ENBF3216C145E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/25/2017
• Initial Date Received by Manufacturer: 05/24/2017
• Supplement Date Received by Manufacturer: Not provided; 06/16/2017
• Initial Report FDA Received Date: 06/12/2017
• Supplement Report FDA Received Date: 06/21/2017; 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: 69 YR