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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 Difficult to Remove (1528); Activation, Positioning or Separation Problem (2906); Material Deformation (2976)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/08/2022
Event Type  Injury  
Event Description
It was reported that stent partial deployment requiring additional intervention occurred.The target lesion was located in a mildly tortuous and mildly calcified superficial femoral artery.A 7x120, 130 cm eluvia drug-eluting vascular stent system was delivered contralaterally to treat the arterial disease.A normal amount of force was required to turn the thumbwheel and the thumbwheel was used until the white arrow was visible to deploy the stent, however, only 50% of the stent was deployed.When removing the deployment mechanism, the stent was then stretched to a longer length.As a result, the surgeon used two innova stents to line the stretched eluvia stent.There were no patient complications reported and the patient fully recovered after the procedure.
 
Manufacturer Narrative
H6: device code difficult to remove was removed.Device analysis by manufacturer: returned product consisted of an eluvia self-expanding stent system with an unknown 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 that the handle is open.The pull rack is separated 5.2cm from the proximal end of the nosecone.The sheath is twisted at the nosecone.There is a kink to the sheath 46cm from the nosecone.The proximal inner is prolapsed.Microscopic examination revealed no additional damages.The stent was deployed and did not return for analysis.Inspection of the remainder of the device, revealed no other damage or irregularities.
 
Event Description
It was reported that stent partial deployment requiring additional intervention occurred.The target lesion was located in a mildly tortuous and mildly calcified superficial femoral artery.A 7x120, 130 cm eluvia drug-eluting vascular stent system was delivered contralaterally to treat the arterial disease.A normal amount of force was required to turn the thumbwheel and the thumbwheel was used until the white arrow was visible to deploy the stent, however, only 50% of the stent was deployed.When removing the deployment mechanism, the stent was then stretched to a longer length.As a result, the surgeon used two innova stents to line the stretched eluvia stent.There were no patient complications reported and the patient fully recovered after the procedure.
 
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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 Key15335100
MDR Text Key299053624
Report Number2134265-2022-08665
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 10/06/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/01/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date11/12/2023
Device Model Number24657
Device Catalogue Number24657
Device Lot Number0028545899
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received09/14/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/12/2021
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
Treatment
GUIDE SHEATH: TERUMO DESTINATION; GUIDE SHEATH: TERUMO DESTINATION
Patient Outcome(s) Required Intervention;
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