It was reported the procedure was performed to treat a lesion in the circumflex artery.An unspecified guide wire was advanced to the target lesion.The guide wire was noted to have a 35-degree bend on the proximal shaft.When advancing the 2.50x15 mm skypoint stent delivery system (sds) over the guide wire, resistance was felt.When inflating the sds, the device was not holding pressure.The balloon was then quickly inflated to 10 atmospheres deploying the stent.The stent deployed fine.The sds was removed without issue.Although not confirmed, a leak is suspected somewhere.A balloon was used for post dilatation.There were no adverse patient effects and no clinically significant delay during the procedure.No additional information was provided.
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The device was not returned for analysis.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.Additionally, a review of the complaint history identified no similar incidents from this lot.The investigation was unable to determine a conclusive cause for the reported difficulties.There is no indication of a product quality issue with respect to manufacture, design, or labeling; therefore, no product-related corrective action will be implemented in this case.
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