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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.
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It was reported that the stent dislodged off the balloon.The vessel was very tortuous.Access was gained by left brachial cut down.A long 8 f flexor cook raabe sheath and a supracore wire were used.The sheath was not long enough to reach the target vessel and the plan was to bareback the stent to reach the target site.A lifestream device was inserted and the stent tracked through the sheath, but would not track outside the sheath to the target site, despite spin and twist techniques to get the device to track.A decision was made to change to a rosen guidewire for better support.When pulling the stent back into the sheath a strange feeling was reportedly noted as if the stent had caught on the end of the sheath and dislodged off the balloon.The stent was on the guidewire and a snare was used to remove it.The sheath was then changed to a 12f cook sheath.This sheath was still not quite long enough to reach the target site so the plan was to attempt to bareback the stent into the internal iliac artery.However, a lifestream device was inserted and the stent dislodged from the balloon at the haemostatic valve of the sheath before it was ever inserted into the patient.The procedure was then abandoned.There was no reported patient injury.It is unknown if this complaint is the device which dislodged in or out of the patient and will be therefore reassessed for both.
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It was reported that the stent dislodged off the balloon.The vessel was very tortuous.Access was gained by left brachial cut down.A long 8 f flexor cook raabe sheath and a supracore wire were used.The sheath was not long enough to reach the target vessel and the plan was to bareback the stent to reach the target site.A lifestream device was inserted and the stent tracked through the sheath, but would not track outside the sheath to the target site, despite spin and twist techniques to get the device to track.A decision was made to change to a rosen guidewire for better support.When pulling the stent back into the sheath a strange feeling was reportedly noted as if the stent had caught on the end of the sheath and dislodged off the balloon.The stent was on the guidewire and a snare was used to remove it.The sheath was then changed to a 12f cook sheath.This sheath was still not quite long enough to reach the target site so the plan was to attempt to bareback the stent into the internal iliac artery.However, a lifestream device was inserted and the stent dislodged from the balloon at the haemostatic valve of the sheath before it was ever inserted into the patient.The procedure was then abandoned.There was no reported patient injury.It is unknown if this complaint is the device which dislodged in or out of the patient and will be therefore reassessed for both.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 not returned for evaluation.The result of the investigation is inconclusive.The sample was not returned for evaluation.User error may and procedural techniques may have contributed to the reported issue.The event description states that the device was removed back through the sheath during the procedure.This is contrary to what is directed in the ifu.In section d indication for use states "attempting to remove an unexpanded covered stent by pulling it back into the sheath/guiding catheter may result in the stent dislodgment".It was also stated that the device would not track outside the sheath to the target site, despite using spin and twist techniques to get the device to track.Based upon the available information a definitive root cause cannot be determined.Based on analysis performed no additional action is required at this time.Note: while the current confirmed calculated rate for this failure mode is 0.073% (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 sept 17 is 0.014%.While this figure is slightly higher than the predicted rate of 0.01% this calculation is based on 13 months of sales which is less than the required 24 months.If the calculation is adjusted for 24 months sales the rate is 0.009% which is below the predicted rate the ifu states: a 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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