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

Device Problem Positioning Failure (1158)

Patient Problem Occlusion (1984)

Event Date 02/01/2017

Event Type  Injury  

Manufacturer Narrative

The lot number has been requested but remains unknown, therefore a review of the manufacturing records for the device could not be conducted.

Event Description

The following information was reported to gore: a poster was presented which included complications associated with the use of gore® viabahn® vbx balloon expandable endoprostheses as branch grafts in a non-gore fenestrated main body aortic grafts.The endoleaks cited in the poster are unrelated to the vbx devices.This event addresses a focal stomach and splenic infarct (likely from loss of splenic artery).The case of gastric and splenic infarction was due to inadvertent covering of both the splenic and left gastric artery with poor collateralization from sma branches.A partial (wedge) gastrectomy and splenectomy was performed.

• 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: heidi inskeep ; 1500 n. 4th street; 9285263030
• MDR Report Key: 8515667
• MDR Text Key: 141976053
• Report Number: 2017233-2019-00248
• Device Sequence Number: 1
• Product Code: NIO
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 03/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2019
• 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): Hospitalization; Other; Required Intervention
• Patient Age: 78 YR