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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It was reported that stent damage occurred.The 99% stenosed target lesion was located in the moderately tortuous distal left circumflex (lcx) artery.After pre-dilatation was performed with a 2.75 x 13 non-bsc balloon catheter, a 3.00 x 20 synergy¿ drug-eluting stent was advanced but failed to cross the tortuous area in the proximal lcx.While trying to advance, it was noted that the distal part of the stent was lifted.The device was simply removed from the patient and the procedure was completed with a different device.No patient complications were reported and the patient's status was stable.
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