Hazard description
Through post-market surveillance, Bolton Medical received complaints where the graft is unable to unclasp from the delivery system because the proximal clasp is disconnected from the outer control tube. This may be recognized by the user as a lack of resistance felt when sliding the apex holder back accompanied by a failure to release the proximal stent. The implant cannot be recaptured at this stage in the procedure. Bolton Medical received 4 complaints associated with this failure mode, 3 of which resulted in death including 1 aortic perforation, and 2 conversions to open surgery which resulted in patient deaths due to stroke.
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