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

Model Number BXAL082902A

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/10/2019

Event Type  malfunction  

Manufacturer Narrative

A review of the manufacturing records indicated the device met pre-release specifications.The device remains in the patient.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.Instructions for use; 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 Description

The following was reported to gore: during treatment of stenotic occlusion in the left subclavian artery, an 8mm x 29mm gore® viabahn® vbx balloon expandable endoprosthesis was to be implanted through a 7fr slender sheath.When the device was advanced to the lesion, the physician made the decision that the device length was too short.The physician retracted the device and met resistance at the sheath, continued to pull and the device became dislodged from the catheter.The physician used a balloon catheter and deployed the device in the radial artery.A second gore® viabahn® vbx balloon expandable endoprosthesis (8mm x 59mm) was advanced across the lesion and deployed successfully.It was reported that the patient tolerated the procedure and is doing well.

Manufacturer Narrative

Additional manufacturer narrative: the referenced complaint did not have a returned device.The following evaluation is based on information obtained from the available information: the complaint was for a gore® viabahn® vbx balloon expandable endoprosthesis (vbx) device that dislodged from the delivery system.The intended location of the device was the subclavian artery with a radial artery access site.The event description states that the selected device was not long enough to cross the intended lesion when it reached the intended deployment site.The doctor attempted to remove the device from the patient but did not follow the warnings section in the ifu.The vbx ifu states the following warning: 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.The physician attempted to remove the vbx device after it had exited the tip of the introducer sheath which resulted in the stent dislodgement.The manufacturing lot history files did not indicate a manufacturing deficiency occurred that would increase the likelihood of stent dislodgement.The crush force of the vbx device onto its delivery system ensures adequate stent retention and is 100% verified in process.The information provided indicates that the vbx device was not used in accordance with the ifu.

Manufacturer Narrative

Corrected data: h6 - method code 2.H6 - results code 2.

Manufacturer Narrative

Corrected data: engineering evaluation; the referenced complaint did not have a returned device.The following evaluation is based on information obtained from the event description and communication summary.Stent dislodgement of the vbx device may be affected by device profile and manufacturing crush force.Device profile is 100% verified during the vbx manufacturing process.The device history file was reviewed and no anomalies were identified.Machine history files were reviewed and no non-routine maintenance was identified.Based on the device evaluation performed, no manufacturing anomalies were identified to which the event could be definitively attributed.

Manufacturer Narrative

Corrected date: h-10./11.Narrative/corrected data: engineering evaluation summary : the referenced complaint did not have a returned device.The following evaluation is based on information obtained from the event description and communication summary.The complaint was for a gore® viabahn® vbx balloon expandable endoprosthesis (vbx) device that dislodged from the delivery system.The intended location of the device was the subclavian artery with a radial artery access site.The event description states that the selected device was not long enough to cross the intended lesion when it reached the intended deployment site.The doctor attempted to remove the device from the patient but did not follow the warnings section in the ifu.The vbx ifu states the following warning: 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; the manufacturing lot history files did not indicate a manufacturing deficiency occurred that would increase the likelihood of stent dislodgement.The information provided in the investigation indicates that the vbx device was not used in accordance with the ifu.

• 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: 9110931
• MDR Text Key: 159833426
• Report Number: 2017233-2019-00896
• Device Sequence Number: 1
• Product Code: NIO
• UDI-Device Identifier: 00733132637805
• UDI-Public: 00733132637805
• 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,Followup,Followup,Followup
• Report Date: 02/04/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 02/03/2022
• Device Model Number: BXAL082902A
• Device Catalogue Number: BXAL082902A
• Device Lot Number: 20559669
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/24/2019
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 12/30/2019; 01/08/2020; 01/15/2020; 02/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 85 YR