Citaat | Parket bij de Hoge Raad 6 september 2013

Onder 1.18.3 Parket bij de Hoge Raad 6 september 2013

Een alinea uit Parket bij de Hoge Raad 6 september 2013, ECLI:NL:PHR:2013:835.

“Medtronic has thoroughly evaluated the Advantage valve to known rigorous standards. The overall clinical performance of the Advantage valve is excellent. Based on reports from clinicians, it is now recognized that the Advantage valve had a rarely expressed characteristic referred to as intermittent regurgitation. Medtronic has received 17 reports of intermittent regurgitation with over 15,000 valves implanted. During the isolated beats when intermittent regurgitation occurs, one of the two leaflets comes very close to closing but does (lees:) not completely close. This characteristic did not manifest itself during pre-clincal testing. Two cases of intermittent regurgitation resulted in misinterpretation of valve performance, leading clinicians, in these two cases, to believe the valve was dysfunctional and resulting in -with hindsight- unnecessary re-operations. Based on these two clinical reports Medtronic communicated worldwide about the phenomenon of intermittent regurgitation. Since that communication there have been no further reports of unnecessary reoperations.”

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