It was reported to gore: a bypass was performed with a 6 mm gore® propaten® vascular graft in the morning, and clotted in the afternoon.The physician went in for revision of the graft at the tibial artery, the doctor mentioned the artery was small but did not indicate the size of the artery diameter.He placed a stent (unknown device) at the tibial artery.Doctor mentioned that only a small portion of the propaten® vascular graft was exposed to the blood stream at the femoral artery due to the additional stent placement.The patient received 6000 iu at the beginning of the procedure, then 2000iu about 45 minutes later during the procedure (it was not clear if he meant initial procedure or de-clot/stent procedure), doctor starting seeing clot after 8000 iu of systemic heparin had been given.He saw clot in the field and thrombus in the graft again, thrombus in the graft was noted as white clot, which could be doctor knew to be indicative of hit.He began the cessation of systemic heparin and placed patient on agatroban®.Has a hematologist on the case; sent out a hit panel, but does not have results yet.Patient platelets were initially 189,000, three days later were measured at 130,000.Doctor didn't believe the small amount of the propaten graft interacting with the blood could trigger hit, but also was concerned that this patient to his knowledge had never received heparin prior to this procedure and had an immediate reaction.Timeline from the doctor suggests he implanted the device in the morning and clot/revision procedure in the afternoon of the same day.Doctor mentioned if he decided he needed to re-operate, he would completely re-do the bypass with a new graft.The doctor decided to explant the gore® propaten® vascular graft and us a different gore device that was not a propaten® device along with agatroban® on (b)(6) 2020.It was stated that the hemotologist still can not explain what happened during the initial surgeries.The explanted graft is being held in the hospital's pathology department, and will be returned to gore once the histology kit has been received.
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Additional manufacturing narrative: c1.Name (#1) - cbas® heparin surface; manufacturer/compounder: w.L.Gore & associates, inc.Lot #5418525pp007.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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Additional manufacturer narrative: examination of the returned device revealed the following: tissue present along the luminal surface of the submitted gore® propaten® vascular graft segment was consistent with acute thrombus.Aside from red blood cells either interspersed throughout and/or sedimented as part of the post-explantation process, the tissue contained few entrapped leukocytes.The amount of tissue, present along the luminal surface, ranged from small to moderate and the lumen of the vascular graft segment was patent.Tissue present along the abluminal surface and within the vascular graft wall was proteinaceous and paucicellular.There was no microscopic evidence of an infection.
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