(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The device was returned for analysis.Visual, dimensional, and functional inspections were performed on the returned device.The reported difficulty removing the guide wire and collapsed lumen were not confirmed with inspection of the returned device.The investigation was unable to determine a conclusive cause for the reported difficulties.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 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 there was no resistance noted when advancing the 3.25x23 xience alpine stent delivery system (sds) over the non-abbott guide wire (gw).The xience alpine was pressurized one time at 18 atms and the stent was deployed without issues.However,as the xience alpine sds was pulled out of the deployed stent, the sion gw also came out unexpectedly, as the sds and gw were stuck together.Thus, the devices were removed out of the anatomy as a single unit.There was no resistance met between the deployed stent and the sds when the sds was removed.The physician comments that the gw lumen on the sds may have collapsed after the single inflation.No significant delay in the procedure was reported.No adverse patient effects were reported.No additional information was provided.
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