Corrected data: h6.Method code 2.H6.Results code 2.H6.Conclusions code 1.Additional manufacturer narrative: examination of the returned device revealed the following: the gore® viabahn® vbx balloon expandable delivery system was returned without the endoprosthesis and did not appear to have been inflated.The device displayed catheter damage at 91 cm from the proximal end of the delivery system.Based on the device evaluation performed, no manufacturing anomalies were identified to which the event could be definitively attributed.The gore® viabahn® vbx balloon expandable endoprosthesis instructions for use warnings section state the following: 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.
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