H3 device evaluated by mfg ¿updated
h3 summary attached - updated
d4 expiration date - corrected
due to the automated mes system there are controls in the manufacturing process to ensure the product met specifications upon release.The device was returned inside a micro catheter.The reported lot number was confirmed from the returned packaging.The expiry date on the carton and pouch labels was 2022-06-29 (26 june 2022).On visual inspection, the stent delivery wire (sdw) was protruding from the distal end of the micro catheter and procedural fluid was also visible.The micro catheter shaft was inspected and no anomaly was noted.Several attempts were made to advance and retract the surpass flow diverter device from the micro catheter without success and despite soaking the micro catheter in warm water.Functional test could not be performed as the device was stuck in the micro catheter shaft.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 indicated that the device prepared as per dfu and continuous flush was maintained.The patient¿s anatomy was moderate-severe tortuous.At least 3 attempts were made to re - sheath the stent into the micro catheter at the middle section (not the whole length to a distal end) of stent to get stent open in the curve and get rid of a ribboning.The inr decided to move the stent`s position more distally to get it landing not in the second curve proximally.The tiny space between the stent`s proximal end and the proximal marker got increased when attempting to re - sheath and recapture into the micro catheter.The stent stayed in the micro catheter.The physician didn¿t know what caused the stent ribboning (stent is not opening and it looks like a twisted stent) but stated it`s known that longer stents have tendency for ribboning in a difficult anatomy.The surpass evolve re-sheath marker band was not located distal to the micro catheter distal marker band at the time of the event, it was proximal to the micro catheter marker.The procedure was completed with a new micro catheter and a shorter evolve 4.0 x 1.There was not really a surgical delay but it took some procedural time to change to another device.The as reported device used past expiration date was not confirmed as the returned packaging showed the expiry date was the 29 june 2022 which is well within the event date of the (b)(6) 2020.Based on the additional information it is probable the stent ribboned due to the patient¿s anatomy and the stent became dislocated from its re - sheath pad during the multiple manipulations of the device when trying to open the stent.An assignable cause of procedural factors will be assigned to the reported flow diverter stent difficult/unable to re-capture into micro catheter, stent deformed, unexpected movement of device and to the analyzed stent difficult/unable to advance or pullback through catheter 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.
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