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

Catalog Number	BXA117902A
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Perforation (2001)
Date of Event	06/11/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of device manufacturing record history confirmed device met pre-release specifications.Device is currently retained by user facility; therefore, direct product analysis is not possible.Instructions for use for gore® viabahn® vbx balloon expandable endoprosthesis (ifu) states, in the warnings section: do not withdraw the gore® viabahn® vbx balloon expandable endoprosthesis back into the introducer sheath once the endoprosthesis is fully introduced.Withdrawing the gore® viabahn® vbx balloon expandable endoprosthesis back into the sheath can cause dislocation and / or damage to the endoprosthesis, premature deployment, deployment failure, and / or catheter separation.If removal prior to deployment is necessary, withdraw the gore® viabahn® vbx balloon expandable endoprosthesis to a position close to but not into the introducer sheath.Both the gore® viabahn® vbx balloon expandable endoprosthesis and introducer sheath can then be removed in tandem.After removal, do not reuse the gore® viabahn® vbx balloon expandable endoprosthesis or introducer sheath.
Event or Problem Description
The following was reported to gore: during an iliac branch procedure, access made from the brachial artery for treatment in the hypogastric artery.As reported, the patient had a tortuous anatomy, plus existing abdominal grafts and a stents in the internal iliac artery.A 9fr x 55cm cook sheath was used to advance a gore® viabahn® vbx balloon expandable endoprosthesis (vbx) over a stiff angled terumo glidewire.Difficulties were encountered while advancing the vbx device through the sheath, and the vbx device was unable to access the hypogastric artery.The vbx device was withdrawn and the wire was exchanged to an amplatz super stiff guidewire.The same vbx device was advanced again and it reached the intended treatment site.When the balloon was inflated, it was noticed the vbx stent had dislodged from the balloon catheter.The stent was at the distal end of the sheath.The constrained vbx device was snared and removed through the groin access.From the brachial artery access, a new vbx device was advanced and deployed with good results.The patient is reported to recovering well following the procedure.

• 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: 8762746
• Report Number: 2017233-2019-00502
• Device Sequence Number: 2039641
• Product Code: NIO
• UDI-Device Identifier: 00733132637768
• UDI-Public: 00733132637768
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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
• Report Date (Section B): 06/11/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/09/2022
• Device Catalogue Number: BXA117902A
• Device Lot Number: 20461052
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 67 YR
• Patient Weight: 112