| Model Number LSMU1351258 |
| Device Problem
Device Dislodged or Dislocated (2923)
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| Patient Problem
No Consequences Or Impact To Patient (2199)
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| Event Date 08/28/2018 |
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Event Type
malfunction
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Manufacturer Narrative
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The catalog number identified has not been cleared in the us, but is similar to the lifestream balloon expandable covered stent products that are cleared in the us.The 510 k number and pro code for the lifestream balloon expandable covered stent products are identified.No medical records and no medical images were provided to the manufacturer.The lot number for the device was provided not, a review of the device history records has not been performed.The return of the device is pending.The investigation is currently underway.
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Event Description
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It was reported that during a stent graft deployment procedure for a stenosed right aic and occlused left aic via an ipsilateral approach through the afc, the balloon expandable vascular covered stent allegedly dislodged from the balloon catheter twice.There was no reported patient injury.
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Manufacturer Narrative
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Manufacturing review: a complete manufacturing review could not be performed as a lot number was not provided.Investigation summary: the evaluation of the returned device has confirmed the dislodged failure mode reported.The stent was returned on its own.The stent was damaged.It appeared that the stent had not been expanded by balloon inflation.A complete manufacturing review could not be conducted, as the lot number was not provided for this device.It is unknown if patient factors, procedural or handling techniques that contributed to the reported event.It was reported that during the stent graft deployment procedure the stent allegedly dislodged from the balloon catheter twice.No further information was received to clarify if this detail was accurate.The definitive root cause for the reported stent dislodgment issue could not be determined based upon available information.Labeling review: the ifu for the lifestream product was reviewed and contains the following information relevant to the reported event: precautions: the device should only be used by physicians who are trained in endovascular procedures and are familiar with the complications, side effects and hazards of peripheral vascular interventions.Prior to device use, refer to the covered stent sizing table on the label and read the instructions for use.Crossing the implant with catheters or other adjunct devices can result in covered stent dislodgement or damage.Potential patient/device adverse effects that may occur include, but are not limited to, the following: covered stent dislodgement from balloon during tracking procedure.Covered stent misplacement during placement procedure.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.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.10.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.(eval code & desc- method 1, results 1, and conclusion 1).
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Event Description
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It was reported that during a stent graft deployment procedure for a stenosed right aic and occlused left aic via an ipsilaterial approach through the afc, the balloon expandable vascular covered stent allegedly dislodged from the balloon catheter twice.There was no reported patient injury.
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Manufacturer Narrative
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H10: manufacturing review: a complete manufacturing review could not be performed as a lot number was not provided.Investigation summary: the evaluation of the returned device has confirmed the dislodged failure mode reported.The stent was returned on its own.The stent was damaged.It appeared that the stent had not been expanded by balloon inflation.A complete manufacturing review could not be conducted, as the lot number was not provided for this device.It is unknown if patient factors, procedural or handling techniques that contributed to the reported event.It was reported that during the stent graft deployment procedure the stent allegedly dislodged from the balloon catheter twice.No further information was received to clarify if this detail was accurate.The definitive root cause for the reported stent dislodgment issue could not be determined based upon available information.Labeling review: the ifu for the lifestream product was reviewed and contains the following information relevant to the reported event: precautions ¿ the device should only be used by physicians who are trained in endovascular procedures and are familiar with the complications, side effects and hazards of peripheral vascular interventions.¿ prior to device use, refer to the covered stent sizing table on the label and read the instructions for use.¿ crossing the implant with catheters or other adjunct devices can result in covered stent dislodgement or damage.Potential patient/device adverse effects that may occur include, but are not limited to, the following: ¿ covered stent dislodgement from balloon during tracking procedure; ¿ covered stent misplacement during placement procedure.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.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.10.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.H10: g4.H11: d4.H11:section a through f - 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.
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Event Description
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It was reported that during a stent graft deployment procedure for a stenosed right aic and occlused left aic via an ipsilaterial approach through the afc, the balloon expandable vascular covered stent allegedly dislodged from the balloon catheter twice.There was no reported patient injury.
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Search Alerts/Recalls
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