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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ELUVIA DRUG-ELUTING VASCULAR STENT SYSTEM; STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING
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BOSTON SCIENTIFIC CORPORATION ELUVIA DRUG-ELUTING VASCULAR STENT SYSTEM; STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING Back to Search Results
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)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/26/2021
Event Type  malfunction  
Manufacturer Narrative
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.
 
Event Description
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.
 
Event Description
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.
 
Manufacturer Narrative
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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Brand Name
ELUVIA DRUG-ELUTING VASCULAR STENT SYSTEM
Type of Device
STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key11568932
MDR Text Key244438910
Report Number2134265-2021-03580
Device Sequence Number1
Product Code NIU
Combination Product (y/n)Y
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Type of Report Initial,Followup
Report Date 04/19/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/25/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date08/28/2022
Device Model Number24653
Device Catalogue Number24653
Device Lot Number0026027779
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/18/2021
Date Manufacturer Received03/30/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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