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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); Material Deformation (2976)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/19/2022
Event Type  malfunction  
Manufacturer Narrative
Initial reporter address 1: (b)(6).Initial reporter state: (b)(6).
 
Event Description
It was reported that the stent was partially deployed and stretched.An eluvia drug-eluting vascular stent system, 7x120, 130 cm was selected for use in the superficial femoral artery.During the procedure, the stent delivery system was advanced to the target lesion, which was reported to be 100% stenosed with mild vessel tortuosity.Stent deployment was reported to be difficult, requiring use of both the thumb wheel and the pull grip.The stent was stretched during deployment but was ultimately deployed.The delivery system was removed.No patient complications were reported.
 
Manufacturer Narrative
E1 - initial reporter address 1: 1 (b)(6).Device media analysis: returned product consisted of an eluvia self-expanding stent system with a non-bsc 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 handle was open when received.The proximal inner was prolapsed.Microscopic examination revealed no additional damages.The stent was deployed and did not return for analysis.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 and stent deformation.
 
Event Description
It was reported that the stent was partially deployed and stretched.An eluvia drug-eluting vascular stent system, 7x120, 130 cm was selected for use in the superficial femoral artery.During the procedure, the stent delivery system was advanced to the target lesion, which was reported to be 100% stenosed with mild vessel tortuosity.Stent deployment was reported to be difficult, requiring use of both the thumb wheel and the pull grip.The stent was stretched during deployment but was ultimately deployed.The delivery system was removed.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
jay johnson
4100 hamline ave n
arden hills, MN 55112
6515810888
MDR Report Key15758645
MDR Text Key306044019
Report Number2124215-2022-45460
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 12/15/2022
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 Date12/14/2023
Device Model Number24653
Device Catalogue Number24653
Device Lot Number0028675384
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/07/2022
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 10/19/2022
Initial Date FDA Received11/09/2022
Supplement Dates Manufacturer Received11/30/2022
Supplement Dates FDA Received12/15/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/14/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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