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Catalog Number H470045 |
Device Problem
Device Operates Differently Than Expected (2913)
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Patient Problem
No Code Available (3191)
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Event Date 02/27/2011 |
Event Type
Injury
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Manufacturer Narrative
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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: 2579473pp013.(b)(4).Medications: simvastatin, asa, plavix.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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Event Description
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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 polytetrafluroethylene (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) 2010, a patient was implanted with a gore propaten vascular graft for arteriovenous access from the brachial artery to the basilic vein in the right arm.It was reported to gore that on (b)(6) 2011, the patient presented with arterial steal syndrome.A reintervention procedure was performed.
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Search Alerts/Recalls
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