Age at time of event: 18 years or older.Device is a combination product.(b)(4).Device evaluated by mfr.: the device was not returned for analysis.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The investigation conclusion is operational context as the product meets the design & manufacture specification but due to anatomical/procedural factors encountered during the procedure, performance was limited.(b)(4).
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It was reported that stent damage occurred.Vascular access was obtained via femoral artery.The 16-48mm x 2.5-3.5mm, eccentric, de novo target lesion with a bend of between 45 to 90 degrees was located in the mildly tortuous and mildly calcified vessel.Following pre-dilatation, a 3.50 x 16 synergy¿ stent was advanced but failed to cross the lesion.When the device was removed, it was noted that the stent was deformed.The procedure was completed with another of the same device.No patient complications were reported and the patient¿s status was stable.
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