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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 24657
Device Problems Activation, Positioning or Separation Problem (2906); Material Deformation (2976); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/11/2023
Event Type  Injury  
Event Description
It was reported that the stent partially deployed and became stretched, requiring additional stent placement.This 7x150, 130 cm eluvia drug-eluting vascular stent system was selected for use in a peripheral stenting procedure.The 100% stenosed target lesion was located in the severely calcified, mildly tortuous right superficial femoral artery.Prior to the use of this eluvia device, the lesion was first treated with atherectomy and a balloon.A contralateral approach was performed, and the stent was deployed halfway when deployment became stuck.The thumb wheel was used but became stuck and quite a bit of force was required to turn it.The pull grip was then used and was pulled completely back.The stent was able to fully deploy; however, it became stretched to approximately twice its original length.Two additional stents were placed to cover the stretched stent.There were no patient complications.
 
Event Description
It was reported that the stent partially deployed and became stretched, requiring additional stent placement.This 7x150, 130 cm eluvia drug-eluting vascular stent system was selected for use in a peripheral stenting procedure.The 100% stenosed target lesion was located in the severely calcified, mildly tortuous right superficial femoral artery.Prior to the use of this eluvia device, the lesion was first treated with atherectomy and a balloon.A contralateral approach was performed, and the stent was deployed halfway when deployment became stuck.The thumb wheel was used but became stuck and quite a bit of force was required to turn it.The pull grip was then used and was pulled completely back.The stent was able to fully deploy; however, it became stretched to approximately twice its original length.Two additional stents were placed to cover the stretched stent.There were no patient complications.
 
Manufacturer Narrative
Device eval by manufacturer: upon receipt at our post market quality assurance laboratory, this 7x150, 130 cm eluvia drug-eluting vascular stent system was returned with an unknown 0.014-inch guidewire stuck in the device.The outer sheath, tip, inner sheath, and the remainder of the device were inspected for damage.Visual examination revealed that the handle was partially open, and the pull rack was separated.The proximal section of the separated pull rack was not returned for analysis.Microscopic examination revealed no additional damage.The stent was deployed and was not returned for analysis.The handle was x-rayed, and the proximal inner was prolapsed.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.
 
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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 Key17662581
MDR Text Key322414135
Report Number2124215-2023-43577
Device Sequence Number1
Product Code NIU
UDI-Device Identifier08714729876748
UDI-Public08714729876748
Combination Product (y/n)Y
Reporter Country CodeUS
PMA/PMN Number
P180011
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 10/09/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number24657
Device Catalogue Number24657
Device Lot Number0030842407
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 08/11/2023
Initial Date FDA Received08/31/2023
Supplement Dates Manufacturer Received09/20/2023
Supplement Dates FDA Received10/09/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/02/2022
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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