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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 Activation, Positioning or Separation Problem (2906); Material Deformation (2976)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/11/2022
Event Type  malfunction  
Event Description
It was reported that the stent partially deployed.A 6mm x 120mm eluvia drug-eluting vascular stent system was selected for use in the superficial femoral artery.The 100% stenosed target lesion was located in severely calcified and moderately tortuous anatomy.It was a contralateral approach, and the tortuosity of the iliac was severe, and the middle shaft may have been trapped.An attempt was made to use a non-boston scientific stent before eluvia, but due to the severe tortuosity of the iliac, the stent could not be deployed, and the entire stent was removed.The eluvia was successfully implanted by pulling the stent while vibrating the entire shaft because the thumbwheel could not be turned when the stent was deployed less than halfway inside the body.The stent was stretched a little.A kink was also noted on the catheter after the stent was deployed.No patient complications were reported.
 
Event Description
It was reported that the stent partially deployed.A 6mm x 120mm eluvia drug-eluting vascular stent system was selected for use in the superficial femoral artery.The 100% stenosed target lesion was located in severely calcified and moderately tortuous anatomy.It was a contralateral approach, and the tortuosity of the iliac was severe, and the middle shaft may have been trapped.An attempt was made to use a non-boston scientific stent before eluvia, but due to the severe tortuosity of the iliac, the stent could not be deployed, and the entire stent was removed.The eluvia was successfully implanted by pulling the stent while vibrating the entire shaft because the thumbwheel could not be turned when the stent was deployed less than halfway inside the body.The stent was stretched a little.A kink was also noted on the catheter after the stent was deployed.No patient complications were reported.
 
Manufacturer Narrative
Device eval by manufacturer: returned product consisted of an eluvia self-expanding stent system.The outer sheath, tip, inner sheath, and the remainder of the device were checked for damage.Visual examination revealed a kink to the sheath at the nosecone.The pull rack was separated at the handle.The proximal section of the pull rack did not return for analysis.Microscopic examination revealed no additional damages.The stent was deployed and did not return for analysis.
 
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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
jay johnson
4100 hamline ave n
arden hills, MN 55112
6515810888
MDR Report Key15737663
MDR Text Key307095462
Report Number2124215-2022-45279
Device Sequence Number1
Product Code NIU
Combination Product (y/n)Y
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative,Distributor
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 11/21/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/04/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date01/06/2024
Device Model Number24653
Device Catalogue Number24653
Device Lot Number0028694478
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/27/2022
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/04/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/06/2022
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
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