Due to the automated mes system there are controls in the manufacturing process to ensure the product met specifications upon release.
During visual inspection, the surpass evolve flow diverter was partially deployed from the distal tip of the xt-27 microcatheter.
The stent was seated correctly on the resheath pad.
The stent was noted to be slightly deformed at the proximal end as frayed ends were present the distal end of the microcatheter was deformed and had collapsed.
During functional testing, the stent delivery wire (sdw) was advanced and the remainder of the stent was deployed without issue.
As the microcatheter shaft had collapsed toward the distal end, it was not possible to resheath the stent.
The reported event is covered in the device directions for use (dfu).
As well, the risk of the reported event is documented in the risk documentation and there are current controls to mitigate the risk of the as reported event.
Additional information provided by the customer regarding the device indicated that there was no damage noted to the packaging or system, it was confirmed that the implant and delivery wire were properly pre-loaded in the distal tip of the introducer sheath, the device was prepared as per the dfu, continuous flush was maintained throughout the procedure and the patient¿s anatomy was not tortuous.
There was no resistance encountered when transferring the implant from the introducer sheath into the microcatheter.
The only resistance encountered was when the physician was trying to resheath the stent, the physician felt tension and it was difficult to resheath.
The stent did not fully expand and was re-captured.
The sales rep felt that the handling of the device was rushed and a little roughly used.
The device was returned and the distal end of the xt-27 microcatheter was deformed and collapsed.
It is possible the xt-27 microcatheter was damaged during advancement through the patient¿s anatomy.
There was some deformation noted to the proximal end of the stent which most likely occurred as a result of attempting to resheath the stent.
The deformed distal end of the xt-27 microcatheter would have contributed to the stent failing to open up fully when unsheathed.
An assignable cause of procedural factors will be assigned to the reported and analyzed issue stent failed/ unable to open (when not implanted) and to the analyzed issues stent partial deployment, stent difficult/unable to pull back into sheath and stent deformed as the issue is associated with a product that meets stryker design and manufacture specifications and was used in according with the dfu but due to procedural and/or anatomical factors during use, the product performance was limited.
This is 1st of 3 reports.
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