Model Number H080040A |
Device Problem
Material Separation (1562)
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Patient Problem
Death (1802)
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Event Date 01/14/2020 |
Event Type
Death
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Manufacturer Narrative
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Additional manufacturer narrative: a review of the manufacturing records indicated the device met pre-release specifications.The device was not returned for an engineering evaluation.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.2 devices were reported to gore.Reference medwatch 2017233-2020-00082 for second device.
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Event Description
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The following was reported to gore: on (b)(6) 2019 an 8mm gore® propaten® vascular graft was implanted as a bypass, common iliac to distal sfa.On (b)(6) 2020 the physician performed a re-exploration as a result of an identified occlusion within the graft.The doctor performed a graft thrombectomy as well as revision of the distal anastomosis, extending treatment by sewing a second graft to the distal anastomosis to the popliteal below knee position.On (b)(6) the graft to graft anastomosis disrupted.According to the doctor, the patient bled out very rapidly and expired.
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Manufacturer Narrative
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Additional manufacturing narrative: name (#1) - cbas® heparin surface.Manufacturer/compounder: w.L.Gore & associates, inc.Lot #6299684pp033.Cbas® heparin surface incorporates cbas-heparin manufactured from heparin sodium api, which is covalently bound to the device surface and is essentially non-eluting.
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Manufacturer Narrative
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The following engineering evaluation was performed with no devices returned to w.L.Gore & associates: two device serial numbers associated with this event were provided, but the identity of the associated devices could not be confirmed.Md142775, gore-tex® vascular graft and gore® propaten® vascular graft process failure modes and effects analysis (pfmea), revision 9 was reviewed for process steps with suture line disruption as a potential device failure mode or occlusion as a potential hazardous situation.Process steps identified span the component/kitting processes in medical west, the heparin coatings/cutting/packaging processes in kendrick peak, and the boxing process in fisher point.All device history records associated with both device serial numbers were reviewed across all aforementioned processes.All appropriate signatures and other evidence of process conformation were verified.The event description could not be confirmed with the information provided.The reported codes reflect the event description, but cannot be confirmed.Additional devices included on this report are as follows: item # ht087080a/ lot # 5918388pp019, which is captured in manufacturer report # 2017233-2020-00082.
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Manufacturer Narrative
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B3: date of event - updated to (b)(6) 2020.
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Search Alerts/Recalls
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