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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 Fracture (1260); Activation, Positioning or Separation Problem (2906); Material Deformation (2976)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/12/2022
Event Type  malfunction  
Event Description
It was reported that the stent partially deployment and fractured.Vascular access was obtained via contralateral approach.The 100% stenosed target lesion was located in the severely calcified and moderate to severely tortuous superficial femoral artery (sfa).A 300cm v-14 control wire and a 7x120, 130cm eluvia drug-eluting vascular stent system were selected for a peripheral revascularization procedure.The lesion was predilated.During the procedure, the distal tip of the v-14 control wire fractured and remained in a subintimal channel in the sfa.Throughout the entire procedure, friction occurred in the systems.During deployment, lots of force was required to deploy the stent.Fifty percent of the stent was deployed when the event occurred.Pulling the pull grip and pulling back on the delivery system ultimately deployed the stent.The stent stretched and fractured.The stent was not removed from the patient and remained in the vessel.The stent was post dilated.No kinks were observed.The non-boston scientific guidewire and the stent delivery system were intact and removed together from the patient.A non-boston scientific.014 guidewire was used to complete the procedure.The procedure was completed successfully and patient's foot was looking better than prior to the procedure.The patient will continued to be followed with more frequent imaging.There were no patient complications.
 
Event Description
It was reported that the stent partially deployment and fractured.Vascular access was obtained via contralateral approach.The 100% stenosed target lesion was located in the severely calcified and moderate to severely tortuous superficial femoral artery (sfa).A 300cm v-14 control wire and a 7x120, 130cm eluvia drug-eluting vascular stent system were selected for a peripheral revascularization procedure.The lesion was predilated.During the procedure, the distal tip of the v-14 control wire fractured and remained in a subintimal channel in the sfa.Throughout the entire procedure, friction occurred in the systems.During deployment, lots of force was required to deploy the stent.Fifty percent of the stent was deployed when the event occurred.Pulling the pull grip and pulling back on the delivery system ultimately deployed the stent.The stent stretched and fractured.The stent was not removed from the patient and remained in the vessel.The stent was post dilated.No kinks were observed.The non-boston scientific guidewire and the stent delivery system were intact and removed together from the patient.A non-boston scientific.014 guidewire was used to complete the procedure.The procedure was completed successfully and patient's foot was looking better than prior to the procedure.The patient will continued to be followed with more frequent imaging.There were no patient complications.
 
Manufacturer Narrative
Device evaluated by mfr: returned product consisted of an eluvia self-expanding stent system with a 0.014 inch guidewire stuck in the device.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 damages.The stent was deployed and did not return for analysis.The handle was x-rayed, and the proximal inner was prolapsed.Media was provided by the customer in the form of a photo.The photo was reviewed by cis investigator and it could not be determined if there is any damage.Inspection of the remainder of the device, revealed no other damage or irregularities.
 
Event Description
It was reported that the stent partially deployment and fractured.Vascular access was obtained via contralateral approach.The 100% stenosed target lesion was located in the severely calcified and moderate to severely tortuous superficial femoral artery (sfa).A 300cm v-14 control wire and a 7x120, 130cm eluvia drug-eluting vascular stent system were selected for a peripheral revascularization procedure.The lesion was predilated.During the procedure, the distal tip of the v-14 control wire fractured and remained in a subintimal channel in the sfa.Throughout the entire procedure, friction occurred in the systems.During deployment, lots of force was required to deploy the stent.Fifty percent of the stent was deployed when the event occurred.Pulling the pull grip and pulling back on the delivery system ultimately deployed the stent.The stent stretched and fractured.The stent was not removed from the patient and remained in the vessel.The stent was post dilated.No kinks were observed.The non-boston scientific guidewire and the stent delivery system were intact and removed together from the patient.A non-boston scientific.014 guidewire was used to complete the procedure.The procedure was completed successfully and patient's foot was looking better than prior to the procedure.The patient will continued to be followed with more frequent imaging.There were no 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
two scimed place
maple grove MN 55311
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
ballybrit business park
galway
EI  
Manufacturer Contact
jay johnson
two scimed place
maple grove, MN 55311
7634942574
MDR Report Key13459358
MDR Text Key285644678
Report Number2134265-2022-00955
Device Sequence Number1
Product Code NIU
UDI-Device Identifier08714729876731
UDI-Public08714729876731
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 03/04/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/04/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date07/21/2023
Device Model Number24657
Device Catalogue Number24657
Device Lot Number0027887908
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/04/2022
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/09/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/21/2021
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
Treatment
GUIDE SHEATH: 6 FRENCH TERUMO DESTINATION.; GUIDE SHEATH: 6 FRENCH TERUMO DESTINATION.; GUIDEWIRE: .035 TERUMO GLIDEWIRE ADVANTAGE.; GUIDEWIRE: .035 TERUMO GLIDEWIRE ADVANTAGE.
Patient SexMale
Patient RaceWhite
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