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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 Activation, Positioning or Separation Problem (2906); Material Deformation (2976)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/24/2022
Event Type  malfunction  
Manufacturer Narrative
Initial reporter address 1: (b)(6).
 
Event Description
It was reported that stent partial deployment occurred and the stent 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 as treatment for lower extremity arterial disease.Pre-dilatation was performed appropriately, and a non-boston scientific guidewire was placed using contralateral approach.During deployment of the stent, the thumb wheel was rotated about halfway, however the stent was not able to be deployed.The entire shaft was removed and it was noticed that the stent was stretched.No patient complications were reported.
 
Manufacturer Narrative
E1: initial reporter address 1: (b)(6).Device eval by manufacturer: returned product consisted of an eluvia self-expanding stent system; the stent was deployed and did not return for analysis.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, the inner sheath was extended, and the pull grip was fully extended.An x-ray was performed and found no damage in the handle, and further microscopic inspection of the remainder of the device presented no other damage or irregularities.
 
Event Description
It was reported that stent partial deployment occurred and the stent 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 as treatment for lower extremity arterial disease.Pre-dilatation was performed appropriately, and a non-boston scientific guidewire was placed using contralateral approach.During deployment of the stent, the thumb wheel was rotated about halfway, however the stent was not able to be deployed.The entire shaft was removed and it was noticed that the stent was stretched.No patient complications were reported.Additional information was received that this stent was able to be deployed, albeit was stretched.
 
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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 Key15016224
MDR Text Key295955109
Report Number2124215-2022-23421
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 Foreign,Health Professional,Company Representative,Distributor
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 08/10/2022
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
Date Returned to Manufacturer07/14/2022
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 06/24/2022
Initial Date FDA Received07/14/2022
Supplement Dates Manufacturer Received07/18/2022
Supplement Dates FDA Received08/10/2022
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
Treatment
GUIDEWIRE: CRUISE.; GUIDEWIRE: CRUISE.
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