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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It was reported that stent damage occurred.The 90% stenosed target lesion was located in the moderately tortuous and moderately calcified obtuse marginal branch.Following pre-dilatation using a 2.0 x 15 non-bsc balloon catheter, a 2.25 x 28 synergy¿ drug-eluting stent was advanced but failed to cross a tortuous area in the proximal left circumflex artery.While attempting to make the device cross, the stent struts were found to be lifted.The procedure was completed with a different device.No patient complications were reported and the patient's status was good.
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