Catalog Number VBJR052502A |
Device Problems
Device Damaged by Another Device (2915); Activation Failure (3270)
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Patient Problem
Perforation (2001)
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Event Date 11/06/2018 |
Event Type
Injury
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Manufacturer Narrative
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Review of device manufacturing record history confirmed device met pre-release specifications.Instructions for use (ifu) for gore® viabahn® endoprosthesis with heparin bioactive surface warnings section states, w.L.Gore & associates has insufficient clinical and experimental data regarding the use of the gore® viabahn® endoprosthesis within stents or stent grafts (other than the gore® viabahn® endoprosthesis with heparin bioactive surface or the gore® viabahn® endoprosthesis) that have been implanted for less than 30 days.Other devices implanted for less than 30 days may interfere with the deployment of the gore® viabahn® endoprosthesis resulting in deployment failure or other device malfunctions.
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Event Description
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The following was reported to gore: patient presented with thrombosis in superficial femoral artery (sfa).A zilver ptx stent was deployed first but blood flow was not re-established.Consequently, a gore® viabahn® endoprosthesis was advanced in order to cover the stenotic lesion.As reported, the zilver ptx stent and the viabahn device were at least 2 cm apart in the native vessel with no overlap.During deployment of the viabahn device, the device expanded about 2 cm when the deployment line became stuck.Further deployment was not possible.A longer sheath was inserted and attempts were made to capture the partially expanded viabahn device.In the process, the viabahn deployment line became entangled with the zilver ptx stent.As a result, a cut down was performed in the patient's right sfa.The viabahn device was cut into two sections and removed along with the zilver ptx stent.The artery was repaired and patient was sent to recovery.
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Manufacturer Narrative
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Device was released and returned from user facility.Field was populated.Code 213: engineering evaluation state the entire device was returned.The deployment knob was cut and separated from the deployment hub.About 2.5cm of deployment line was connected to the constrained end of the endoprosthesis at the transition.The distal shaft upon which the endoprosthesis is mounted, appeared to have been cut approximately 20.5cm from the transition.The endoprosthesis was cut along with the distal shaft, approximately 5cm from the tip.The endoprosthesis was partially expanded 1cm at the tip end.The inner braided constraining line was deployed approximately 1cm.Based on the device examination performed, no manufacturing anomalies were identified.
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Search Alerts/Recalls
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