It was reported that after pre-dilating a mildly calcified, concentric, 75% stenosed 10-mm-long lesion in the moderately tortuous 2.25mm diameter distal circumflex coronary artery with a 2.0mm non-abbott balloon catheter, a 2.25x12 xience alpine stent delivery system (sds) was advanced without force applied, but failed to cross the lesion due to patient anatomy.In order to perform additional dilatation with a balloon, the xience alpine was withdrawn from the anatomy, without resistance, when it was noted that there was shredding and flaring of the balloon material at the proximal part of the balloon.While no damage was noted to the stent struts and the stent remained firmly crimped on the balloon, the xience alpine was not used to complete the procedure due to the balloon shredding/flaring.Reportedly, the shredded balloon did not appear to have detached from the balloon inside of patient anatomy.Another 2.25x12 xience alpine sds was able to cross the lesion successfully and was deployed without issue, completing the procedure.There was no occurrence of a clinically significant delay and no adverse patient effects.No additional information was provided.
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(b)(4).Evaluation summary: the device was returned for analysis; however, there was no balloon material shredding and flaring noted at the proximal part of the balloon as reported but there was a foreign material on the proximal part of the balloon for a length of 2 mm confirming the reported unusual appearance.Additional follow-up confirmed that the correct complaint device had been returned and that the unidentified material is likely what was thought to be flared/peeled/shredded (balloon) material.A chemical analysis showed that the unidentified material to resemble hemoglobin and human skin.The reported unusual appearance was able to be confirmed.The reported failure to advance the device was unable to be replicated in a testing environment as it was based on operational circumstances.The investigation determined the reported difficulties appear to be related to circumstances of the procedure.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 did not indicate a lot specific quality issue.Based on the information reviewed, there is no indication of a product quality issue with respect to manufacture, design or labeling.
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