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

Device Problems Partial Blockage (1065); Collapse (1099)

Patient Problem Occlusion (1984)

Event Date 05/02/2018

Event Type  Injury  

Manufacturer Narrative

Review of the manufacturing records could not be completed as no lot number information was provided.The device was not returned.Consequently, a direct product analysis was not possible.Additional information about this event could not be obtained.As a result, no further investigation is possible.All information has been placed on file for use in tracking and trending.

Event Description

The following was reported to gore from the doctor: the gore® viabahn® vbx balloon expandable endoprosthesis (vbx) was placed in the sma on (b)(6) 2019 during a cook fenestrated case.According to the doctor the gore device slightly occluded.

Event Description

The following was reported to gore from the doctor: the gore® viabahn® vbx balloon expandable endoprosthesis (vbx) was placed in the sma on (b)(6) 2018 during a cook fenestrated case.According to the doctor the gore device slightly occluded.

Manufacturer Narrative

Corrected data: b3: date of event.B5: describe event or problem.D6: if implanted, give date.Additional manufacturer narrative: g5: combination product.

• Brand Name: GORE VIABAHN VBX BALLOON EXPANDABLE ENDOPROSTHESIS
• Type of Device: STENT, ILIAC
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 8827584
• MDR Text Key: 152454124
• Report Number: 2017233-2019-00562
• Device Sequence Number: 1
• Product Code: NIO
• Combination Product (y/n): N
• PMA/PMN Number: P160021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 09/16/2019

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?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/25/2019
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 69 YR