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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 Positioning Failure (1158); Premature Activation (1484); Material Deformation (2976)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/19/2021
Event Type  malfunction  
Event Description
It was reported that the stent inadvertently deployed.A 6mm x 120mm, 130cm eluvia drug-eluting vascular stent system was selected for use in a stenting procedure within the superficial femoral artery.The 100% stenosed target lesion was severely calcified and located in moderately tortuous anatomy.During the procedure, the dial was turned about 20 clicks, but there was mild resistance.The stent did not deploy at all.The eluvia device was pulled out, and the guidewire was replaced.The eluvia opened 1 to 2cm on its own on the table outside the body.The procedure was completed with another of the same device.No patient complications were reported.
 
Manufacturer Narrative
Device eval by manufacturer: upon receipt at our post market quality assurance laboratory, this 6mm x 120mm, 130cm eluvia drug-eluting vascular stent system was examined, for damage.Visual examination revealed multiple kinks along the sheath.The stent is partially deployed approximately 27mm from the middle sheath.Microscopic examination revealed no additional damages.Inspection of the remainder of the device, revealed no other damage or irregularities.
 
Event Description
It was reported that the stent inadvertently deployed.A 6mm x 120mm, 130cm eluvia drug-eluting vascular stent system was selected for use in a stenting procedure within the superficial femoral artery.The 100% stenosed target lesion was severely calcified and located in moderately tortuous anatomy.During the procedure, the dial was turned about 20 clicks, but there was mild resistance.The stent did not deploy at all.The eluvia device was pulled out, and the guidewire was replaced.The eluvia opened 1 to 2cm on its own on the table outside the body.The procedure was completed with another of the same device.No patient complications were reported.
 
Manufacturer Narrative
Device eval by manufacturer: upon receipt at our post market quality assurance laboratory, this 6mm x 120mm, 130cm eluvia drug-eluting vascular stent system was examined, for damage.Visual examination revealed multiple kinks along the sheath.The stent is partially deployed approximately 27mm from the middle sheath.Microscopic examination revealed no additional damages.Inspection of the remainder of the device, revealed no other damage or irregularities.
 
Event Description
It was reported that the stent inadvertently deployed.A 6mm x 120mm, 130cm eluvia drug-eluting vascular stent system was selected for use in a stenting procedure within the superficial femoral artery.The 100% stenosed target lesion was severely calcified and located in moderately tortuous anatomy.During the procedure, the dial was turned about 20 clicks, but there was mild resistance.The stent did not deploy at all.The eluvia device was pulled out, and the guidewire was replaced.The eluvia opened 1 to 2cm on its own on the table outside the body.The procedure was completed with another of the same device.No patient complications were reported.It was further reported that the proximal end of the catheter at the distal end of the handle was kinked when packing the device for return to manufacturer.
 
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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 Key11826242
MDR Text Key250849042
Report Number2134265-2021-06353
Device Sequence Number1
Product Code NIU
Combination Product (y/n)Y
PMA/PMN Number
P180011
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Type of Report Initial,Followup,Followup
Report Date 06/11/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/14/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date10/20/2022
Device Model Number24653
Device Catalogue Number24653
Device Lot Number0026341269
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/14/2021
Date Manufacturer Received05/17/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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