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

Catalog Number	BXA061902A
Medical Device Problem Codes	Improper or Incorrect Procedure or Method (2017); Detachment of Device or Device Component (2907); Premature Separation (4045)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	08/28/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Review of the manufacturing records verified that the lot met release requirements.The device was not returned.Consequently, a direct product analysis was not possible.
Event or Problem Description
The patient presented for a aaa fenestrated case.The gore® viabahn® vbx balloon expandable endoprosthesis (vbx) was targeted to go into the renal.The doctor was unable to place the sheath into the renal so decided to advance the vbx bareback.During advancement, the stent dislodged from the balloon.The balloon and stent were retrieved and discarded at the hospital.
Additional Manufacturer Narrative
Additional manufacturer narrative: the device was not returned to gore for analysis.However, an engineering analysis based on the device codes was conducted.Examination of the device history and machine history files did not indicate any anomalies occurred that would increase the device profile or decrease the force to dislodge the vbx stent from the delivery system.The gore® viabahn® vbx balloon expandable endoprosthesis instructions for use, directions for use, section f introduction and positioning of the gore® viabahn® vbx balloon expandable endoprosthesis state: 1.Select the compatible size introducer sheath from table 1.Always use an appropriately sized sheath for the implant procedure.It is advisable to use a sheath or guide catheter that is long enough to cross the lesion.Use of a guide sheath or guide catheter minimizes the risk of dislodging the endoprosthesis from the balloon during tracking.Use standard interventional techniques to introduce the gore® viabahn® vbx balloon expandable endoprosthesis to the target lesion.

• Brand Name: GORE VIABAHN VBX BALLOON EXPANDABLE ENDOPROSTHESIS
• Common Device Name: STENT, ILIAC
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 8972944
• Report Number: 2017233-2019-00817
• Device Sequence Number: 2654261
• Product Code: NIO
• UDI-Device Identifier: 00733132637171
• UDI-Public: 00733132637171
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P160021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/04/2021
• Device Catalogue Number: BXA061902A
• Device Lot Number: 20220386
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/06/2019
• Supplement Report FDA Received Date: 12/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 79 YR