Product performance engineering reviewed the incident information; however, the product was not returned to abbott vascular for analysis.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no other similar incidents and/or complaints reported from this lot.There was no damage noted to the stent delivery system (sds) during the inspection prior to use which suggests a product quality issue with respect to manufacture, design or labeling did not contribute to the reported difficulties.The investigation determined the reported failure to advance, difficulty to remove and stent damage appear to be related to operational circumstances of the procedure.Based on the reported information, during advancement the sierra sds encountered resistance with the mildly calcified and moderately tortuous anatomy resulting in the failure to advance.Mishandling of the device or the device being strongly pushed against resistance resulted in the reported stent damage and difficulty to remove from the guiding catheter.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
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