Catalog Number VBH130502A |
Device Problems
Failure to Unfold or Unwrap (1669); Activation Failure (3270)
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Patient Problem
No Information (3190)
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Event Date 06/12/2019 |
Event Type
malfunction
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Manufacturer Narrative
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Review of the manufacturing records indicated the device met pre-release specifications.The investigation is ongoing.
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Event Description
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The following was reported to gore by the or nurse: the gore® viabahn® endoprosthesis with heparin coating did not completely open.
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Manufacturer Narrative
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Corrected data: b5.Describe event or problem.
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Event Description
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The following was reported to gore by the doctor: the patient presented for open arch repair.The doctor placed the gore® viabahn® endoprosthesis in the innominate artery.When the deployment line was pulled, the doctor observed it to appear to unravel.The gore® viabahn® endoprosthesis did not completely open.The doctor continued the repair using open technique.
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Manufacturer Narrative
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Additional manufacturer narrative: d10: returned to manufacturer on: (mm/dd/yyyy) examination of the returned device revealed the following: the endoprosthesis, delivery catheter, and part of the deployment line were returned; the deployment knob with a section of the deployment line was not returned; the deployment line was broken with four single fibers coming out of the body of the catheter, approximately 7 cm from the hub; the first fiber measured 34 cm and was intertwined with another fiber measuring approximately 6 cm; the other two fibers measured approximately 56 and 40 cm.All fibers appeared to be fraying at the ends; the deployment line near the endoprosthesis was unremarkable; the endoprosthesis was partially expanded approximately 2 cm; there were 2 cm of the endoprosthesis still constrained by the inner braided constraining line; deployment was able to be continued with traction on the deployment line at the endoprosthesis; the remainder of the device was unremarkable.Based on the device examination performed, no manufacturing anomalies were identified to which the event could be definitively attributed.Corrected data: h6: results code 2 h6: conclusions code 1 h10: device available for evaluation? (do not send to fda).
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Search Alerts/Recalls
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