Model Number 24653 |
Device Problems
Difficult to Remove (1528); Activation, Positioning or Separation Problem (2906); Material Deformation (2976); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/26/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Device evaluated by manufacturer:returned product consisted of an eluvia self-expanding stent system with a 0.014 inch guidewire stuck in the device.The outer sheath, tip, inner sheath and the remainder of the device were checked for damage.Visual examination revealed a kink to the outer sheath at the nosecone.Microscopic examination revealed no additional damages.The stent was deployed and did not return for analysis.The handle was disassembled, and the proximal inner was prolapsed.Inspection of the remainder of the device, revealed no other damage or irregularities.Product analysis found damage that would have contributed to deployment issues.
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Event Description
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It was reported that partial stent deployment and stent damage occurred.The 100% stenosed target lesion was located in the moderately tortuous and moderately calcified superficial femoral artery (sfa).A 6f non-bsc introducer sheath was placed and a.014 inch guidewire was advanced to lesion via a contralateral approach.The lesion was pre-dilated with a either a 6mm or 7mm balloon catheter.The 7x120x130 eluvia self-expanding stent was selected for use.Deployment was initiated via the deployment thumbwheel without resistance until the white arrow on the pull grip became visible.The deployment pull grip was also utilized to deploy the eluvia stent.The eluvia stent failed to deploy.It was observed that the eluvia stent became stretched during stent placement.The stent eventually deployed and was placed in the target lesion.Removal difficulties were encountered during the removal of the eluvia stent delivery system.The entire stent delivery system and guidewire were removed together.The procedure was completed with this device.There were no patient complications.
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Event Description
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It was reported that partial stent deployment and stent damage occurred.The 100% stenosed target lesion was located in the moderately tortuous and moderately calcified superficial femoral artery (sfa).A 6f non-bsc introducer sheath was placed and a.014 inch guidewire was advanced to lesion via a contralateral approach.The lesion was pre-dilated with a either a 6mm or 7mm balloon catheter.The 7x120x130 eluvia self-expanding stent was selected for use.Deployment was initiated via the deployment thumbwheel without resistance until the white arrow on the pull grip became visible.The deployment pull grip was also utilized to deploy the eluvia stent.The eluvia stent failed to deploy.It was observed that the eluvia stent became stretched during stent placement.The stent eventually deployed and was placed in the target lesion.Removal difficulties were encountered during the removal of the eluvia stent delivery system.The entire stent delivery system and guidewire were removed together.The procedure was completed with this device.There were no patient complications.It was further reported when the stent became difficult to deploy, more than half of the stent had been deployed.The guidewire used was from another manufacturer.
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Manufacturer Narrative
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Device evaluated by manufacturer:returned product consisted of an eluvia self-expanding stent system with a 0.014 inch guidewire stuck in the device.The outer sheath, tip, inner sheath and the remainder of the device were checked for damage.Visual examination revealed a kink to the outer sheath at the nosecone.Microscopic examination revealed no additional damages.The stent was deployed and did not return for analysis.The handle was disassembled, and the proximal inner was prolapsed.Inspection of the remainder of the device, revealed no other damage or irregularities.Product analysis found damage that would have contributed to deployment issues.
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Search Alerts/Recalls
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