Catalog Number VBH100502A |
Device Problem
Detachment of Device or Device Component (2907)
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Patient Problem
Occlusion (1984)
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Event Date 06/24/2019 |
Event Type
malfunction
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Manufacturer Narrative
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Review of the manufacturing records verified that the lot met release requirements.Examination of the returned device revealed the following: the deployment knob, deployment line, and the delivery catheter were returned; the deployment line was fully intact though it appeared to have been broken as there were two single fibers on the end of the deployment line; the deployment line was approximately 170cm including the single fibers which were 10cm and 17cm; the remainder of the device appeared unremarkable.Based on the device examination performed, no manufacturing anomalies were identified to which the event could be definitively attributed.All information has been placed on file for use in tracking and trending.
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Event Description
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The following was reported to gore: the av/dialysis patient presented for central venous and cephalic arch stenosis treatment.The gore® viabahn® endoprosthesis (viabahn) was advanced to the treatment site in the cephalic arch and deployed without issue.However, the deployment line remained attached to the viabahn.The doctor, on a separate wire, advanced a 10x4 mustang¿ balloon into the viabahn and inflated it to full size.This fixated the viabahn allowing the doctor to pull the deployment line while his assistant pushed on the balloon.The combination of simultaneously pushing the balloon and pulling the deployment line freed the deployment line.The deployment line was removed from the patient.The patient tolerated the procedure.
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Manufacturer Narrative
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Additional manufacturer narrative: examination of the returned device revealed the following: the deployment knob, deployment line, and the delivery catheter were returned; the deployment line was fully intact though it appeared to have been broken as there were two single fibers on the end of the deployment line; the deployment line was approximately 170cm including the single fibers which were 10cm and 17cm; the remainder of the device appeared unremarkable.Based on the device examination performed, no manufacturing anomalies were identified to which the event could be definitively attributed.
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Search Alerts/Recalls
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