MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES GORE VIABAHN® ENDOPROSTHESIS - 3; NIP

Device Problem Partial Blockage (1065)

Patient Problems Death (1802); Occlusion (1984)

Event Date 09/07/2017

Event Type  Death  

Manufacturer Narrative

Review of the manufacturing records could not be performed as no lot number information was provided.The device was not returned.Consequently, direct product analysis was not possible.Additional information about this event could not be obtained.As a result, no conclusion can be drawn.All information has been placed on file for use in tracking and trending.It is unclear if the implanted device was gore® viabahn® vbx balloon expandable endoprosthesis (ref.Medwatch #2017233-2020-00024) or gore® viabahn® endoprosthesis.

Event Description

Published abstract "two-year evaluation of fenestrated and parallel branch endografts for the treatment of juxtarenal, suprarenal,and thoracoabdominal aneurysms at a single institution" (mohsen bannazadeh, m.D., william e.Beckerman, m.D., adam h.Korayem, m.D., and james f.Mckinsey, m.D., new york, ny; copyright 2019 published by elsevier inc.On behalf of the society for vascular surgery; https://doi.Org/10.1016/j.Jvs.2019.03.058) was reviewed.The abstract discusses the mortality, graft patency, renal function, complication, and reintervention rates for fenestrated and parallel endografts in complex aortic aneurysms repairs from august 2014 to march 2017 in a single center.The abstract reported in the mortality and survival section a patient developed mesenteric ischemia as a result of celiac artery thrombosis likely owing to incomplete collateral circulation between the celiac artery and the sma.The patient presented with elevated liver enzymes and postoperative day 1 with subsequent rapid deterioration and multiorgan failure despite celiac artery revascularization on postoperative day 1.It is unclear if the implanted device was gore® viabahn® vbx balloon expandable endoprosthesis or gore® viabahn® endoprosthesis.

• Brand Name: GORE VIABAHN® ENDOPROSTHESIS - 3
• Type of Device: NIP
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• Manufacturer (Section G): MEDICAL ECHO RIDGE B/P; 3250 w. kiltie lane; flagstaff AZ 86005
• Manufacturer Contact: craig bearchell ; 1500 n. 4th street; 9285263030
• MDR Report Key: 9582718
• MDR Text Key: 174840895
• Report Number: 2017233-2020-00023
• Device Sequence Number: 1
• Product Code: PFV
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P040037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 75 YR