|
Model Number 26280 |
Device Problems
Positioning Failure (1158); Failure to Advance (2524); Material Deformation (2976); Material Integrity Problem (2978)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 03/24/2023 |
Event Type
malfunction
|
Event Description
|
It was reported that stent damage occurred.The patient presented with advanced lung cancer with severe space-occupying lesion.Angiography was performed which revealed an over 85% stenosed target lesion located in the severely tortuous superior vena cava.The patient was placed in supine position and puncture was performed through the right femoral artery with a 10f puncture sheath.A 0.035 amplatz guidewire was then advanced to the lesion and pre-dilatation was performed with a 6x100, 8x100, and 12x80 mustang balloon catheters.Due to severe tortuosity of the blood vessel, the balloon retracted severely after crossing.Subsequently, a 14x90/9fr 75cm wallstent endoprosthesis was advanced to treat the lesion.However, after multiple attempts to cross the lesion, the stent could not be deployed.The device was removed and it was noted that the cover of the stent and the stent itself were damaged.Deployment was tested outside the patient body but there was difficulty encountered.The procedure was completed with another of same device.There were no patient complications reported and the patient's status was stable.
|
|
Event Description
|
It was reported that stent damage occurred.The patient presented with advanced lung cancer with severe space-occupying lesion.Angiography was performed which revealed an over 85% stenosed target lesion located in the severely tortuous superior vena cava.The patient was placed in supine position and puncture was performed through the right femoral artery with a 10f puncture sheath.A 0.035 amplatz guidewire was then advanced to the lesion and pre-dilatation was performed with a 6x100, 8x100, and 12x80 mustang balloon catheters.Due to severe tortuosity of the blood vessel, the balloon retracted severely after crossing.Subsequently, a 14x90/9fr 75cm wallstent endoprosthesis was advanced to treat the lesion.However, after multiple attempts to cross the lesion, the stent could not be deployed.The device was removed and it was noted that the cover of the stent and the stent itself were damaged.Deployment was tested outside the patient body but there was difficulty encountered.The procedure was completed with another of same device.There were no patient complications reported and the patient's status was stable.
|
|
Manufacturer Narrative
|
Device evaluated by mfr.: a 14x90/9fr uni plus 75cm was received for analysis.The device was received with the stent fully constrained in the correct position on the device.The investigator successfully deployed the stent without issue.A visual examination identified kinking to the deployed stent.The outer sheath was found to be kinked at more than one location.This type of damage is consistent with excessive force being applied to the device.The inner sheath was found to be kinked at the same location as the outer sheath.This type of damage is consistent with excessive force being applied to the device.The device was received with the stent fully constrained in the correct position on the device.The investigator successfully deployed the stent without issue.A visual examination identified kinking to the deployed stent at the same location as the sheath when it was mounted on the delivery system.A visual examination identified no damage or issues with the stent holder/cup or tip of the device.
|
|
Search Alerts/Recalls
|
|
|