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The information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.Receipt of device is not expected.The investigation is currently in progress.Not returned.
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It was reported that the stent was loose on the balloon.Prior to a stent placement procedure, the stent was allegedly loose on the balloon.The stent was noted to be loose prior to putting the device on the guidewire, after opening the packaging.The device was handled according to the ifu.There was no damage noted to the box, tray or stent cover.There was no difficulty removing the device from the box or tray and no difficulty removing the stent cover.There was no force required when using the device.The intended treatment site was the right common iliac artery.Another device was used to complete the procedure.There was no reported patient contact.
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It was reported that the stent was loose on the balloon.Prior to a stent placement procedure, the stent was allegedly loose on the balloon.The stent was noted to be loose prior to putting the device on the guidewire, after opening the packaging.The device was handled according to the ifu.There was no damage noted to the box, tray or stent cover.There was no difficulty removing the device from the box or tray and no difficulty removing the stent cover.There was no force required when using the device.The intended treatment site was the right common iliac artery.Another device was used to complete the procedure.There was no reported patient contact.The lot history records have been reviewed with special attention to the manufacturing and inspection of this product.The device was found to have met specifications prior to shipment.No manufacturing anomalies were identified that may have caused or contributed to the reported event.This is the first reported complaint for this lot number and issue to date.The device was returned for evaluation.External and internal packaging was returned.The hub was printed as expected and there were no visual defects noted.The stent guard was not returned.No visual defects were noted on the tip or inner.There was a slight bulge on the outer approx.560mm from the hub.The sheath was not returned with the device.No visual damage was noted on the balloon.It is evident that the balloon was never inflated.It was noted that the stent was dislodged approx.3.5mm towards the distal tip and positioned over the distal marker band.A 0.035" guidewire was inserted into the device through the hub, the guidewire passed through without any issue.The result of the investigation is confirmed.The evaluation of the returned device has confirmed for the stent dislodged/dislocated failure mode reported.The stent was dislodged approx.3.5mm towards the distal tip and positioned over the distal marker band.Based upon the available information a definitive root cause cannot be determined.It is also unknown whether handling or procedural techniques may have contributed to the reported event.Based on analysis performed no additional action is required at this time.Note: while the current confirmed calculated occurrence rate for this failure mode is 0.08% (last 24 months) and is hence higher than the predicted rate of 0.01% the rate is decreasing since the process improvement (action from capa) was introduced into production during sept 16.The current rate from sept 16 to oct 17 is 0.02%.While this figure is slightly higher than the predicted rate of 0.01% this calculation is based on 14 months of sales which is less than the required 24 months.If the calculation is adjusted for 24 months sales the rate is 0.01% which is equal to the predicted rate.The ifu states: device description: implant: the lifestream¿ balloon expandable vascular covered stent is comprised of an electropolished balloon-expandable stent made from 316l stainless steel, encapsulated between two layers of eptfe.Indication for use: the lifestream¿ balloon expandable vascular covered stent is indicated for the treatment of atherosclerotic lesions in common and external iliac arteries.Directions for use: site access and preparation: using standard techniques access the artery and place an introducer sheath or guiding catheter of appropriate inner diameter and a 0.035" (0.89 mm) guidewire across the target lesion.Perform diagnostic angiography to confirm site of implantation and measure the reference vessel diameter and lesion length.Covered stent size selection: select a covered stent diameter that is approximately 5%-20% larger than the largest reference vessel diameter at the proximal or distal target site.Refer to the sizing table on the packaging label for appropriate selection of the covered stent diameter and length.Endovascular system preparation: carefully remove the selected device from the package.Inspect the covered stent for adherence to the balloon and centered placement in relation to the balloon marker bands.If the covered stent is not centered and/or does not firmly adhere to the balloon, do not use.Flush the delivery system guidewire lumen with sterile saline mixture until saline drops from the distal end of the endovascular system.Air evacuation: a 20 cc or smaller luer-lock syringe with a minimum of 5 cc¿s sterile saline mixture is recommended for use for aspirating this device.With the distal balloon tip pointing down and positioned below the level of the syringe, pull negative pressure until all air is expelled.Induce a negative pressure to remove any air from the balloon and inflation lumen.Repeat until all air is expelled.Carefully release to neutral.Allow the inflation lumen to fill with the diluted contrast medium and maintain a neutral pressure.Important: do not apply positive pressure to the balloon.Attach the prefilled inflation device to the inflation lumen of the catheter hub, ensuring no air bubbles remain at the catheter connection.Verify that the covered stent is still centered between the two radiopaque markers on the balloon catheter.Introduction of the endovascular system and placement of the covered stent advance the endovascular system over the guidewire into the introducer sheath.Further advance the endovascular system to the target treatment site within the introducer sheath and position the covered stent across the lesion.Verify that the covered stent is still centered within the balloon marker bands.Slowly retract the introducer sheath / guiding catheter while maintaining the position of the covered stent.Ensure the introducer sheath is retracted far enough to not compromise the balloon expansion and covered stent release.(b)(4).
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