Catalog Number VBHR081002A |
Device Problem
Detachment of Device or Device Component (2907)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 05/06/2019 |
Event Type
malfunction
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Manufacturer Narrative
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A review of the manufacturing records for the device is currently in progress.An engineering investigation is currently in progress.
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Event Description
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The following information was reported to gore: on (b)(6) 2018 a patient was undergoing treatment of an av access vessel stenosis in the thigh with a gore® viabahn® endoprosthesis.No adverse outcomes were reported and the patient tolerated the procedure.On (b)(6) 2019 a balloon angioplasty was performed in a non-treated segment of the vessel.When the balloon catheter was being removed from the vessel, through the previously implanted viabahn, some resistance was noted.The balloon catheter and sheath were removed together.An olive tip with a small segment (approximately 10 mm) of a delivery catheter came out along with the balloon catheter and sheath.There was no adverse outcome for the patient.
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Manufacturer Narrative
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Results code 2: 213: the engineering evaluation stated the following: the distal shaft, upon which the endoprosthesis was mounted, and the distal tip were returned.The distal shaft was kinked approximately 8 cm from the tip end of the distal shaft.The distal shaft measured approximately 13 cm from the tip end of the distal shaft and the pebax did not appear to be disrupted on the transition end of the distal shaft.Engineering evaluation conclusions are: transition bond separation.Based on the device examination performed, this event has the potential to relate to a manufacturing deficiency.Conclusion code 1: updated.
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Manufacturer Narrative
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H.3.Updated.
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Search Alerts/Recalls
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