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 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 id: 2134265-2018-05888.It was reported that stent damage occurred.The target lesion was located in a mildly tortuous and moderately calcified coronary artery.A 4.00 x 28mm synergy¿ drug-eluting stent was advanced but failed to cross the lesion.However, when the device was removed, it was noted that distal end of the stent struts were flared.Pre-dilation was then performed, another 4.00 x 28mm synergy¿ drug-eluting stent was advanced but also failed to cross the lesion and when the device was removed, it was also noted that the distal end of the stent struts were flared.The procedure was completed with another two 4.0mm synergy stent.No patient complications were reported and the patient's status was stable.
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