Shemesh d, goldin i, hijazi j.A prospective randomized study of heparin-bonded graft (propaten) versus standard graft in prosthetic arteriovenous access.J vasc surg 2015;62:115-22.Lot: 2395947pp012 (b)(4).Medications: coumadin.A review of the manufacturing records for the device verified that the lot met all pre-release specifications.The device remained implanted; consequently, a direct product analysis was not possible.
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In the medical literature, an article, "a prospective randomized study of heparin-bonded graft (propaten) versus standard graft in prosthetic arteriovenous access." was reviewed.Patients with end-stage renal failure requiring a prosthetic access were randomized to receive either a standard expanded polytetrafluoroethylene (eptfe) graft or a heparin-bonded eptfe graft.Patients were enrolled from june 2007 until november 2011 and were followed up until july 2013, when the study concluded.The performance of gore propaten vascular grafts in resisting thrombosis, decreasing early failure and possibly prolonging patency was assessed.On (b)(6), 2009, a patient was implanted with a gore propaten vascular graft for arteriovenous access from the brachial artery to the basilic vein in the left arm.It was reported to gore that on (b)(6), 2009, the patient presented with a thrombosed graft.A declot procedure was performed.
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