Model Number HGK0008-70 |
Device Problem
Device Operates Differently Than Expected (2913)
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Patient Problem
Death (1802)
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Event Date 06/26/2015 |
Event Type
malfunction
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Event Description
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During a right axilofemoral by-pass surgery performed on (b)(6) 2015, it was noted that the graft had a very high permeability and was not retaining the fluid.The graft was not implanted.The surgery was completed with another graft.The patient died with no link established between the graft and the patient death.
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Manufacturer Narrative
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A review of the device history records, including collagen coating records, indicated that the graft was processed and inspected according to procedures and no anomaly was found.Specifically, the review of the water permeability testing records of products coated on the same day and under the same conditions as the complaint device indicated values well within product specifications.One retention sample coated on the same period and under the same conditions as the complaint device underwent water permeability testing at 120mmhg as per iso 7198.The test result indicated a value well within product specifications.The returned device was sent to an outside laboratory for scanning electron microscopy analysis.The investigation is still on going.A follow-up report will be submitted upon completion of the investigation.
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Manufacturer Narrative
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The product was not used at it was suspected to present a high porosity the complaint device has been sent to an outside laboratory for macroscopic and scanning electron microscopy (sem) evaluation.The sem analysis showed no significant abnormality such as tear, extensive filament rupture, sectioning, loss of the textile cohesion or hole, neither macroscopically nor ultrastructurally.The presence of collagen was confirmed.No conclusion can be drawn.However, all available information and the product testing performed would tend to indicate that the device was not defective.
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Event Description
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The graft was suspected to have a very high permeability and was not used at all.
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Search Alerts/Recalls
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