(b)(4).Evaluation summary: (b)(4).The device was returned for analysis.The stent damage was able to be confirmed.Based on a visual inspection of the returned device, there is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.The investigation determined the reported stent damage appears to be related to circumstances of the procedure.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot.Additionally, a review of the complaint history identified no similar incidents from this lot.Based on the information reviewed, there is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
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It was reported that the procedure was performed to treat a mildly tortuous and calcified lesion in the left circumflex vessel.The 2.25 x 15 mm xience prime stent delivery system (sds) was advanced into the anatomy, but it was found that a stent strut was flared.Therefore, a new 2.25 x 15mm xience prime sds and finished the procedure successfully.There were no adverse patient effects and no clinically significant delay in the procedure.Returned device analysis found a tear in the distal end of the balloon.No additional information was provided.
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