This is 2 of 2 reports (2nd mdr) due to the automated manufacturing execution system (mes) system there are controls in the manufacturing process to ensure the product met specifications upon release.During visual inspection the device was returned together with another stent device.The stent was found to be deployed and not returned.The proximal part of the stent stabilizer was found to be broken/fractured.Blood within the stent stabilizer was noted.The stent delivery catheter was found to be kinked/bent in multiply areas.The stent stabilizer was found to be kinked/bent in multiply areas.Functional inspection to test the reported event ¿stent stabilizer broken/fractured during use¿ was not required as it was confirmed during visual inspection.The device was flushed.There was friction noted between stent stabilizer and stent delivery catheter due to damages to the devices.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.Both reported events were confirmed, and the analysis results are consistent with the reported event.The device did not meet specifications when received for complaint investigation based on the analysed anomalies noted to the device.Additional information received indicated that the device was prepared for use as per the directions for use.There was no damage noted to the packaging and the device was confirmed to be in good condition prior to use on the patient.Continuous flush was set up and maintained throughout the clinical procedure.It was reported that 'an attempt was made to insert the subject stent in combination with the guidewire to approach the target stenotic vessel and attempted stent deployment, but the outer sheath could not be pulled at all, and the proximal part of the shaft was damaged.Therefore, the system was removed and replaced with a new one in the same catalog number'.In the follow-up good faith effort (gfe) process it was answered on two (2) separate occasions that, during advancement or repositioning of the device, the inner body was advanced independently of the outer body.The subject stent dfu instructs that the only time you move the inner body independently of the outer body is immediately prior to stent deployment.Extract from stent dfu: 'loosen the delivery system outer body rotating hemostasis valve, and advance the delivery system inner body until the proximal radiopaque markerband bumper is just proximal to the stent.Tighten the outer body rotating hemostasis valve'.It is not clear from the available information if the stent stabilizer was advanced independently of the stent system outer body after the stent had traversed the lesion.This may have been a contributing factor to the reported complaint.The stent was not returned for analysis.The stent delivery catheter was kinked/bent at several locations along its length.The stent stabilizer was kinked/bent at several locations along its length.In addition it was noted to be broken/fractured at it's proximal end with the molded rotating hemostatic valve (rhv) missing from the proximal end of the stabilizer.During functional testing, an attempt was made to advance the stent stabilizer, and significant friction was noted between the stent stabilizer and the delivery catheter.Damage to the stabilizer most likely occurred due to the difficulty experienced when attempting to deploy the stent.It is not clear why there was an initial issue deploying the stent but it is most likely that it was due to the severe tortuosity of the patients anatomy.It may also have been related to the damage noted to the outer catheter.The reported events: ¿stent stabilizer/catheter friction' and 'stent stabilizer broken/fractured during use' and the as analysed events: ¿stent stabilizer broken/fractured during use, ¿stent stabilizer/catheter friction¿, ¿stent delivery catheter kinked/bent¿, ¿stent stabilizer kinked/bent¿ will be assigned procedural factors as this complaint appears to be associated with a product that met stryker design and manufacturing specifications and was used in accordance with the dfu, but performance was limited due to procedural and/or anatomical factors during use.
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It was reported that during a medial artery stenosis procedure, after a pre-dilation with the balloon, the guidewire was used to bring the stent to the target stenotic vessel.Next, the operator attempted to deploy the stent, however the outer sheath could not be pulled at all, and the proximal part of the shaft got fractured.The stent was removed and replaced with the subject stent.The operator brought the subject stent to the target stenotic lesion and attempted to deploy it.However, the outer sheath could not be pulled at all, and the proximal part of the shaft got fractured.The procedure was completed as is.No adverse consequences were reported to the patient due to this event.
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