BOSTON SCIENTIFIC CORPORATION WALLSTENT-UNI ENDOPROSTHESIS; PROSTHESIS, TRACHEAL, EXPANDABLE
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Model Number 26650 |
Device Problems
Material Deformation (2976); Activation Failure (3270)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/30/2021 |
Event Type
malfunction
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Event Description
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It was reported that stent damage occurred.The patient presented with may thurner syndrome.The 71.3mm x 16.71mm, 50% compressed target lesion was located in the non-calcified and mildly tortuous left iliac vein.Following pre-dilatation of a 8x 100mm balloon catheter, a 16 x 40mm x 75cm wallstent-uni endoprosthesis was advanced for treatment.The physician then noticed that the stent was not opening to the expected diameter.The device was fully reconstrained and removed from the patient.The physician deployed the stent again outside the patient, it was noted that the distal part of the stent strut was unbraided and lifted.Another 16 x 40mm x 75cm wallstent-uni endoprosthesis was used, however, the stent did not expand.It was also noticed outside the patient that the stent strut was also lifted.The procedure was completed with another of same device.There were no patient complications reported.The patient status was stable.
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Manufacturer Narrative
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Device evaluated by manufacturer.: the wallstent uni 16 x 40mm x 75cm was returned for analysis.The device was received with the stent in the correct position on the device.The investigator successfully deployed the stent without resistance or issue experienced.A microscopic examination found no damage or issues with the deployed stent.A visual and microscopic examination identified no damage or issues with the delivery system, shaft or tip of the device that could potentially have contributed to the complaint incident.No issues were identified during the product analysis.
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Event Description
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It was reported that stent damage occurred.The patient presented with may thurner syndrome.The 71.3mm x 16.71mm, 50% compressed target lesion was located in the non-calcified and mildly tortuous left iliac vein.Following pre-dilatation of a 8x 100mm balloon catheter, a 16 x 40mm x 75cm wallstent-uni endoprosthesis was advanced for treatment.The physician then noticed that the stent was not opening to the expected diameter.The device was fully reconstrained and removed from the patient.The physician deployed the stent again outside the patient, it was noted that the distal part of the stent strut was unbraided and lifted.Another 16 x 40mm x 75cm wallstent-uni endoprosthesis was used, however, the stent did not expand.It was also noticed outside the patient that the stent strut was also lifted.The procedure was completed with another of same device.There were no patient complications reported.The patient status was stable.
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