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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)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/10/2023
Event Type  malfunction  
Event Description
It was reported that the stent was partially deployed.An eluvia drug-eluting vascular stent system was selected for use in the percutaneous transluminal angioplasty procedure in the lower limb.The moderately tortuous target lesion was located in the superficial femoral artery (sfa) and was accessed via a contralateral approach.A non-boston scientific 0.035 guidewire was placed, and the target lesion was pre-dilated.The first eluvia stent was implanted successfully in the distal portion of the sfa without incident.When the second eluvia was attempted to be deployed, a strong force was needed to rotate the thumbwheel, and the thumbwheel reportedly spun-out after the stent was only partially deployed.The entire system was pulled back to fully deploy the stent.When the delivery system was attempted to be removed, there was interference with the guidewire.The entire system was pulled together as one unit as a result.The procedure was completed, and there were no reported patient complications.
 
Manufacturer Narrative
Device analysis: returned product consisted of an eluvia self-expanding stent system with a flimsy 0.035 in.Hydrophilic guidewire stuck inside.The outer sheath, tip, inner sheath, and the remainder of the device were checked for damage.Visual examination revealed a kink to the outer sheath at the nosecone.Microscopic examination revealed no additional damages.The handle was x-rayed, and the proximal inner was prolapsed.The stent appeared to have been 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 reported partial deploy and froze on wire.
 
Event Description
It was reported that the stent was partially deployed.An eluvia drug-eluting vascular stent system was selected for use in the percutaneous transluminal angioplasty procedure in the lower limb.The moderately tortuous target lesion was located in the superficial femoral artery (sfa) and was accessed via a contralateral approach.A non-boston scientific 0.035 guidewire was placed, and the target lesion was pre-dilated.The first eluvia stent was implanted successfully in the distal portion of the sfa without incident.When the second eluvia was attempted to be deployed, a strong force was needed to rotate the thumbwheel, and the thumbwheel reportedly spun-out after the stent was only partially deployed.The entire system was pulled back to fully deploy the stent.When the delivery system was attempted to be removed, there was interference with the guidewire.The entire system was pulled together as one unit as a result.The procedure was completed, and there were no reported patient complications.
 
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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
300 boston scientific way
marlborough MA 01752
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
ballybrit business park
galway MN
EI  
Manufacturer Contact
rachel shields
4100 hamline ave n
arden hills, MN 55112
6512422111
MDR Report Key17438313
MDR Text Key320254240
Report Number2124215-2023-40773
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,Distributor
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 09/12/2023
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 Date04/04/2024
Device Model Number24653
Device Catalogue Number24653
Device Lot Number0029388103
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/28/2023
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 07/10/2023
Initial Date FDA Received08/01/2023
Supplement Dates Manufacturer Received08/17/2023
Supplement Dates FDA Received09/12/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/05/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
ELUVIA DRUG-ELUTING VASCULAR STENT SYSTEM; ELUVIA DRUG-ELUTING VASCULAR STENT SYSTEM
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