The device was not returned 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 similar incidents from this lot.It was reported that the 2.80x19 graftmaster covered stent was inserted into a 5.5 french (f) guide liner and met resistance.It should be noted that the graftmaster rapid exchange (rx) coronary stent graft system, domestic, instructions for use specifies: appropriate guiding catheter(s) ¿ 7f / 0.074" id for 4.50 ¿ 4.80 mm diameter graftmaster rx, or 6f / 0.068" id for 2.80 mm ¿ 4.00 mm diameter graftmaster rx.It is unknown if the ifu deviation contributed to the reported event.A conclusive cause for the reported difficulties could not be determined.There is no indication of a product quality issue with respect to manufacture, design, or labeling.
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