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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 or Delayed Positioning (1157); Entrapment of Device (1212); Material Deformation (2976)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/15/2022
Event Type  malfunction  
Event Description
It was reported that the stent was stretched proximally during deployment, and that the guidewire was unable to be removed from the delivery system.An eluvia eu, 7x120, 130 cm was selected for use to treat peripheral artery disease (pad) in the superficial femoral artery (sfa).The moderately tortuous target lesion was reported to be moderately calcified and 90% stenosed.In preparation for the eluvia, the target lesion was pre-dilated.The eluvia was advanced to the target lesion, but due to the calcification, the middle sheath was unable to be removed.As a result, the entire system was advanced with slight tension and the pull grip was utilized.The stent was deployed successfully within the target lesion, with the proximal portion stretching slightly.The jupiter guidewire used in conjunction with the eluvia system became stuck and the entire device was removed together.There were no reported adverse patient consequences.
 
Event Description
It was reported that the stent was stretched proximally during deployment, and that the guidewire was unable to be removed from the delivery system.An eluvia eu, 7x120, 130 cm was selected for use to treat peripheral artery disease (pad) in the superficial femoral artery (sfa).The moderately tortuous target lesion was reported to be moderately calcified and 90% stenosed.In preparation for the eluvia, the target lesion was pre-dilated.The eluvia was advanced to the target lesion, but due to the calcification, the middle sheath was unable to be removed.As a result, the entire system was advanced with slight tension and the pull grip was utilized.The stent was deployed successfully within the target lesion, with the proximal portion stretching slightly.The jupiter guidewire used in conjunction with the eluvia system became stuck and the entire device was removed together.There were no reported adverse patient consequences.
 
Manufacturer Narrative
Device media analysis: returned product consisted of an eluvia self-expanding stent system with an unknown 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 that the sheath was kinked 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.The handle was x-rayed, 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 the deployment issue, froze on wire, and stent deformation.
 
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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 Key15926396
MDR Text Key307799296
Report Number2124215-2022-48658
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 Other,Foreign,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 01/12/2023
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 Date01/18/2024
Device Model Number24653
Device Catalogue Number24653
Device Lot Number0028783690
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 11/16/2022
Initial Date FDA Received12/06/2022
Supplement Dates Manufacturer Received12/15/2022
Supplement Dates FDA Received01/12/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/18/2022
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
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