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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 Problem Activation Failure (3270)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/01/2022
Event Type  malfunction  
Event Description
It was reported that the stent failed to fully expand.A 6x120, 130 cm eluvia drug-eluting vascular stent system was selected for use in this superficial femoral artery stenting procedure.The target lesion was severely calcified with severe tortuosity along with a vessel diameter of 6mm.After pre-dilation was performed, the eluvia was deployed, however, the radial force was not enough to treat the lesion.It was noted that the stent was fully deployed, but was not able to fully expand due to the severe calcification.The procedure was completed with this device.No patient complications were reported.
 
Manufacturer Narrative
Correction to field h6: evaluation conclusion codes.
 
Event Description
It was reported that the stent failed to fully expand.A 6x120, 130 cm eluvia drug-eluting vascular stent system was selected for use in this superficial femoral artery stenting procedure.The target lesion was severely calcified with severe tortuosity along with a vessel diameter of 6mm.After pre-dilation was performed, the eluvia was deployed, however, the radial force was not enough to treat the lesion.It was noted that the stent was fully deployed, but was not able to fully expand due to the severe calcification.The procedure was completed with this device.No patient complications were reported.
 
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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
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
ballybrit business park
galway
EI  
Manufacturer Contact
jeff wallner
4100 hamline ave n
arden hills, MN 55112
6515811560
MDR Report Key16010226
MDR Text Key307920756
Report Number2124215-2022-52879
Device Sequence Number1
Product Code NIU
Combination Product (y/n)Y
Reporter Country CodeKS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Distributor
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 04/26/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date08/06/2023
Device Model Number24653
Device Catalogue Number24653
Device Lot Number0027886045
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 12/02/2022
Initial Date FDA Received12/19/2022
Supplement Dates Manufacturer Received04/05/2023
Supplement Dates FDA Received04/26/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/06/2021
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
Patient Age80 YR
Patient SexMale
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