Age at time of event: 18 years or older. device is a combination product. (b)(4).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 and manufacture specification but due to anatomical/procedural factors encountered during the procedure, performance was limited.(b)(4).
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Same case as mdr# 2134265-2018-05654.It was reported that stent damage occurred.Vascular access was obtained via the femoral artery.The 95% stenosed, 20-38mm x 2.25-3.0mm, eccentric and the de novo target lesion was located in the mildly tortuous and mildly calcified mid to distal right coronary artery extending to the bifurcation of the left circumflex artery.The lesion contained between a 45 and 95 degree bend.A 2.50 x 20mm synergy¿ drug-eluting stent (des) was advanced for treatment; however, significant resistance was encountered during advancing.When the device was removed, it was noted that the stent was damaged.A 2.25 x 38mm synergy¿ des was advanced but difficulty insertion into the lesion was also encountered.The device was removed and it was noted that the stent was deformed.Finally, the procedure was completed with another of same device.No patient complications were reported and the patient's status was stable.
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