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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 expected.The investigation is currently in progress.Not returned.
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It was reported that the stent dislodged when advancing into the sheath.There were no anomalies noted during the prep of the device.There was no damage noted to the box, tray or stent cover and there was no difficulty removing the stent cover.Reportedly during prep air evacuation was not performed and they did not wet the balloon down.The target lesion was the iliac artery.The patient was being treated for stenosis.A benson guidewire and a cook ansel 7x35 introducer sheath were used.Access was made via the right common femoral artery.An ipsilateral approach was made.The stent allegedly detached from the balloon as the stent was advancing into the introducer sheath.The stent got caught on the valve of the sheath.When the stent dislodged it went backwards so the delivery system was just pulled back to remove it.No negative pressure has been applied to the balloon.Another device was used to complete the procedure.Guidewire access was maintained throughout 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 returned separate from the device.No visual defects were noted on the inner, outer or tip.The stent was returned on the device however, it was dislodged fully off the balloon, and positioned approx.10mm from the proximal markerband on the outer.The stent was slightly flattened at the proximal end.No damage was observed on the balloon.The balloon was never inflated.There was evidence of crimp markings noted on the balloon between the two markerbands.A 7f cook introducer sheath was returned with the device.No functional examination was carried out on the device as it was not applicable to the complaint.The result of the investigation is confirmed.The evaluation of the returned device confirmed that the stent was returned on the device but was dislodged fully off the balloon and positioned approx.10mm from the proximal markerband on the outer.User error / procedural techniques may have been contributing factors.Air evacuation was not performed during the device preparation.Based upon the available information a definitive root cause cannot be determined.It is also unknown if there were other procedural or handling techniques that contributed to the reported event.Based on analysis performed no additional action is required at this time.(b)(4).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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