Device Problems
Partial Blockage (1065); Collapse (1099)
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Patient Problem
Occlusion (1984)
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Event Date 05/02/2018 |
Event Type
Injury
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Manufacturer Narrative
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Review of the manufacturing records could not be completed as no lot number information was provided.The device was not returned.Consequently, a direct product analysis was not possible.Additional information about this event could not be obtained.As a result, no further investigation is possible.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 from the doctor: the gore® viabahn® vbx balloon expandable endoprosthesis (vbx) was placed in the sma on (b)(6) 2019 during a cook fenestrated case.According to the doctor the gore device slightly occluded.
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Event Description
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The following was reported to gore from the doctor: the gore® viabahn® vbx balloon expandable endoprosthesis (vbx) was placed in the sma on (b)(6) 2018 during a cook fenestrated case.According to the doctor the gore device slightly occluded.
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Manufacturer Narrative
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Corrected data: b3: date of event.B5: describe event or problem.D6: if implanted, give date.Additional manufacturer narrative: g5: combination product.
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Search Alerts/Recalls
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