W. L. GORE & ASSOCIATES, INC. GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE; STENT, SUPERFICIAL FEMORAL ARTERY
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Model Number VBJR062502A |
Device Problems
Difficult to Remove (1528); Difficult to Advance (2920)
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Patient Problem
Stenosis (2263)
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Event Date 04/18/2022 |
Event Type
Injury
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Manufacturer Narrative
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Cbas® heparin surface incorporates cbas-heparin manufactured from heparin sodium apl, which in covalently bound to the device surface and is essentially|non-eluting.
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Event Description
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The following information was reported to gore: on (b)(6) 2022, a gore® viabahn® endoprosthesis with propaten bioactive surface was intended for use in the superficial femoral artery for treatment of occlusion.After the lesion was pre-ballooned, the physician attempted to advance the vsx device over a 0.014" hi-torque spartacore, through a 6fr flexor® ansel guiding sheath.However, the physician was unable to advance the device through the occluded lesion.After multiple attempts to retract the vsx device, the physician was unable to removed the device from the occluded lesion.The decision was made to cut the delivery catheter near the skin and convert the patient to surgical conversion.The patient did not experience any adverse consequences.
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Manufacturer Narrative
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Section h6 updated to reflect completion of investigation.Manufacturing records were reviewed, and the device met all pre-release specifications.The reported primary device failure mode, related to difficulty advancing the device, could not be independently confirmed.However, the cause is considered to be related the vessel stenosis as reported by the physician.Evaluation of the returned device yielded observations of a distally compressed endoprosthesis, a kinked and cut distal shaft, and a partially deployed outer zipper.These observations (excepting the cut distal shaft) are consistent with device interactions with the reported vessel stenosis during attempted withdrawal.Cause of the reported event cannot be established based on evaluation of the returned delivery system and the information reported to gore.Further information regarding this event was requested by gore, but no further information has been reported, therefore this investigation is considered complete.
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