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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.The device was received.The investigation is currently in progress.
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The device did not fit through a 6f introducer sheath.There were no anomalies noted during the prep of the device.There was no damage noted to the box, tray or stent cover.The target lesion was the sma.The procedure was an aaa procedure.A terumo 300 0.035 guidewire and a cook 6f, 55cm sheath were used.Access was made via the femoral artery.The device was inserted into the sheath however resistance was felt going through the sheath and the device could not be advanced through.The delivery system and implant were removed together with the sheath.Once removed there was no damage noted to the sheath, implant or delivery system.Multiple attempts to insert the device into he sheath were not made.Air evacuation was not performed.The device was not pulled back into the sheath at any time.Another 6x37 lifestream device was used with a 7f cook sheath to complete the procedure.Guidewire access was maintained throughout the procedure.There was no patient injury reported.
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The device did not fit through a 6f introducer sheath.There were no anomalies noted during the prep of the device.There was no damage noted to the box, tray or stent cover.The target lesion was the sma.The procedure was a aaa procedure.A terumo 300 0.035 guidewire and a cook 6f, 55cm sheath were used.Access was made via the femoral artery.The device was inserted into the sheath however resistance was felt going through the sheath and the device could not be advanced through.The delivery system and implant were removed together with the sheath.Once removed there was no damage noted to the sheath, implant or delivery system.Multiple attempts to insert the device into the sheath were not made.Air evacuation was not performed.The device was not pulled back into the sheath at any time.Another 6x37 lifestream device was used with a 7f cook sheath to complete the procedure.Guidewire access was maintained throughout the procedure.There was no patient injury reported.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 second reported complaint for this lot number and issue to date.For the first complaint the result of the investigation was inconclusive due to no sample returned.For this complaint 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.It was noted that the outer was stretched approx.10mm in length, 860mm from the strain relief.The stent was not returned.It was evident that there was crimpmarks on the balloon and there was no visual damage noted.A 60cm cook 6f introducer sheath was returned with the device.There was dark liquid substance noted within the side tube.Due to no stent present on the balloon no attempt was made to insert the device into the 6f introducer sheath returned.Two unsuccessful attempts were made to insert a 0.035" guidewire through the device.Two blockages prevented this.The first blockage was noted approx.860mm from the hub.This was due to the stretched inner.The second blockage was noted approx.450mm from the tip when the guide wire was inserted though the distal tip.The outer was then cut close at the second blockage.With the use of a 0.014" guide wire the blockage of dried blood was then forced out.The result of the investigation is inconclusive for the device incompatibility failure mode reported.Due to the stent not been returned, a functional examination with the returned sheath was not performed.There is no information provided on how the stent became dislodged.User error and using the device off label may have been contributing factors in the reported issue.The event description outlines that air evacuation was not performed.It also describes that the target lesion was the sma and that the procedure was an aaa procedure.The lifestream stent is intended only in the treatment of atherosclerotic lesions in the common and external iliac arteries per the ifu.Based upon the available information a definitive root cause has not been 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 0.041% (last 24 months) and is hence higher than the predicted rate of 0.02% the rate is decreasing since the process improvement (action from capa) was introduced into production on the 17th sept 16.The current rate from sept 16 to oct 17 is 0.014%.This figure is lower than the predicted rate of 0.02%.Also this calculation is based on 14 months of sales which is less than the required 24 months.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.B 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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