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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)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/21/2023
Event Type  malfunction  
Manufacturer Narrative
Device evaluated by mfr: returned product consisted of an eluvia self-expanding stent system.The outer sheath, tip, inner sheath and the remainder of the device were checked for damage.Visual examination revealed, that the handle is open.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 occurred.Two 6x150, 130cm eluvia drug-eluting vascular stent systems were selected for use.During the procedure, both stents would not completely deploy.The handles, of both devices, were broken apart to pin and pull the stents for full deployment.The stents fully deployed at this point.There were no patient complications.And the patient is doing well post procedure.
 
Manufacturer Narrative
B5: describe event or problem: additional information.E1: initial reporter title, initial reporter first name, initial reporter last name- additional information.E3: occupation- updated.H6: device codes (2)- added code.C2/d10: concomitant product/therapy (1): added guidewire.H6: evaluation conclusion codes (1): updated code.H6: evaluation method codes (3): added code.Device evaluated by mfr: returned product consisted of an eluvia self-expanding stent system.The outer sheath, tip, inner sheath and the remainder of the device were checked for damage.Visual examination revealed that the handle is open and the clip is missing.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 occurred.Two 6x150, 130cm eluvia drug-eluting vascular stent systems were selected for use.During the procedure, both stents would not completely deploy.The handles, of both devices, were broken apart to pin and pull the stents for full deployment.The stents fully deployed at this point.There were no patient complications and the patient is doing well post procedure.It was further reported that access was gained via ipsilateral approach.The target lesion was a difficult sub intimal with a high degree of calcification.It took hours to cross and prepare the lesion.A 0.035 inch guidewire was used.The stents exhibited stacking and an audible sound was heard in the handle prior to the rack pull.During the end of the deployment with the second stent, the stent elongated.
 
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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
jeff wallner
4100 hamline ave n
arden hills, MN 55112
6515811560
MDR Report Key17021172
MDR Text Key316216436
Report Number2124215-2023-27211
Device Sequence Number1
Product Code NIU
UDI-Device Identifier08714729876625
UDI-Public08714729876625
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 06/15/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/30/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number24657
Device Catalogue Number24657
Device Lot Number0030067086
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/15/2023
Is the Reporter a Health Professional? Yes
Date Manufacturer Received05/17/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/05/2022
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
Treatment
GUIDEWIRE: 0.035 INCH STIFF GLIDE ADVANTAGE
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