MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES GORE VIABAHN VBX BALLOON EXPANDABLE ENDOPROSTHESIS; STENT, ILIAC

Device Problems Partial Blockage (1065); Complete Blockage (1094); Patient-Device Incompatibility (2682)

Patient Problem Occlusion (1984)

Event Date 09/21/2019

Event Type  Injury  

Manufacturer Narrative

Additional 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.(b)(4).

Event Description

Conference presentation 'short term outcome of gore vbx stent grafts compared to atrium icast stent grafts for fevar' (c.Deslarzes-dubuis, m.D.; kenneth tran, m.D.; benjamin colvard, m.D.; graeme mcfarland, m.D.; michael sgroi, m.D.; jason lee, m.D.; 2019 charing cross; stanford medicine - vascular & endovascular surgery) was reviewed.The presentation compares the gore® viabahn® vbx balloon expandable endoprosthesis (vbx) to the icast performance for renal stenting in fenestrated endovascular repair (fevar).The presentation identifies complications for the vbx cohort that included one stent occlusion in the right renal artery.

• Brand Name: GORE VIABAHN VBX BALLOON EXPANDABLE ENDOPROSTHESIS
• Type of Device: STENT, ILIAC
• 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: 9787571
• MDR Text Key: 190682235
• Report Number: 2017233-2020-00141
• Device Sequence Number: 1
• Product Code: NIO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P160021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2020
• 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): Other
• Patient Age: 73 YR