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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 to Remove (1528); Activation, Positioning or Separation Problem (2906)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/30/2023
Event Type  malfunction  
Event Description
It was reported that the stent partially deployed.An eluvia drug-eluting vascular stent system was selected for use in the superficial femoral artery.The target lesion was reported to be 100% stenosed with moderate tortuosity.The target vessel was predilated prior to eluvia use.During deployment, the thumbwheel was felt to be spinning idly with about 2 cm of stent deployment remaining.By pulling the entire system, the stent was able to be fully deployed.When the physician attempted to remove the sheath, it was observed that the delivery system was stuck.The handle of the delivery system was taken apart to search for the root cause of the resistance, but no root cause was identified.The entire delivery system was removed along with the sheath.There were no reported patient complications.
 
Event Description
It was reported that the stent partially deployed.An eluvia drug-eluting vascular stent system was selected for use in the superficial femoral artery.The target lesion was reported to be 100% stenosed with moderate tortuosity.The target vessel was predilated prior to eluvia use.During deployment, the thumbwheel was felt to be spinning idly with about 2 cm of stent deployment remaining.By pulling the entire system, the stent was able to be fully deployed.When the physician attempted to remove the sheath, it was observed that the delivery system was stuck.The handle of the delivery system was taken apart to search for the root cause of the resistance, but no root cause was identified.The entire delivery system was removed along with the sheath.There were no reported patient complications.
 
Manufacturer Narrative
Device analysis: returned product consisted of an eluvia self-expanding stent system with an unknown 0.014in guidewire 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.The proximal inner was buckled 12.5cm from the clip.Microscopic examination revealed no additional damages.The unknown guidewire was able to be removed.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 difficulty removing the device.
 
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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
EI  
Manufacturer Contact
rachel shields
4100 hamline ave n
arden hills, MN 55112
6512422111
MDR Report Key18364186
MDR Text Key330993778
Report Number2124215-2023-72384
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,Company Representative,Distributor
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 02/14/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/20/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number24653
Device Catalogue Number24653
Device Lot Number0029657934
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/23/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/01/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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