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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 Entrapment of Device (1212); Activation, Positioning or Separation Problem (2906); Material Deformation (2976)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/06/2022
Event Type  malfunction  
Event Description
It was reported that the stent was partially deployed, and it was impossible to pull the device alone due to interference with the wire.After pulling the entire system the stent was deployed, however it had stretched.A 6mm x 120mm, 130cm eluvia drug-eluting vascular stent system was selected for use in a stenting procedure in the superficial femoral artery with moderate tortuosity as treatment for lower extremity peripheral arterial disease.Pre-dilatation was performed appropriately, and a 0.014" guidewire was placed using contralateral approach.During deployment of the stent, there was resistance felt when rotating the thumbwheel and the stent became partially deployed (even after turning the thumbwheel fully).It was attempted to remove the eluvia system, however, it was impossible to only remove the eluvia system due to interference between the wire and eluvia system.The entire system was pulled together and the stent became fully deployed, however, it was noted that it had stretched from about 12cm to 14cm.No patient complications were reported.
 
Manufacturer Narrative
Device eval by manufacturer: returned product consisted of an eluvia self-expanding stent system from batch 28658321.The wheel lock and flushing luer were removed and not returned.The pull grip was fully extended, and the stent was deployed and not returned.Visual inspection was performed on the outer sheath, tip, inner sheath, and the remainder of the device and found a kink at the nosecone.An x-ray of the handle found a prolapse of the inner.Inspection of the remainder of the device, revealed no other damage or irregularities.
 
Event Description
It was reported that the stent was partially deployed, and it was impossible to pull the device alone due to interference with the wire.After pulling the entire system the stent was deployed, however it had stretched.A 6mm x 120mm, 130cm eluvia drug-eluting vascular stent system was selected for use in a stenting procedure in the superficial femoral artery with moderate tortuosity as treatment for lower extremity peripheral arterial disease.Pre-dilatation was performed appropriately, and a 0.014" guidewire was placed using contralateral approach.During deployment of the stent, there was resistance felt when rotating the thumbwheel and the stent became partially deployed (even after turning the thumbwheel fully).It was attempted to remove the eluvia system, however, it was impossible to only remove the eluvia system due to interference between the wire and eluvia system.The entire system was pulled together and the stent became fully deployed, however, it was noted that it had stretched from about 12cm to 14cm.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 Key15118012
MDR Text Key296868007
Report Number2124215-2022-25465
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 Health Professional,Company Representative,Distributor
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 08/30/2022
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 Number0028658321
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 07/06/2022
Initial Date FDA Received07/27/2022
Supplement Dates Manufacturer Received08/10/2022
Supplement Dates FDA Received08/30/2022
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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