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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 Problem Material Deformation (2976)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/22/2024
Event Type  Injury  
Event Description
It was reported that the stents foreshortened.Eluvia was selected for use in a lower limb angioplasty and stenting procedure.A downhill puncture was used to access the occluded and stenosed superficial femoral artery (sfa).A 6mm x 200mm sterling balloon was used to predilate the sfa.After balloon angioplasty, a 6mm x 120mm eluvia was inserted into the sfa.After deploying, the eluvia stent foreshortened by at least 20-30mm.This was verified by inserting a 6mm x 120mm balloon as a gauge in angio.It was decided to extend the stent with a 6mm x 40mm eluvia.The same foreshortening of the eluvia stent happened again when the second stent was deployed.Another 6mm x 40mm eluvia was used for extension.The stents were deployed from the proximal to distal sfa.The procedure was successfully completed.No patient complications were reported.
 
Event Description
It was reported that the stents foreshortened.Eluvia was selected for use in a lower limb angioplasty and stenting procedure.A downhill puncture was used to access the occluded and stenosed superficial femoral artery (sfa).A 6mm x 200mm sterling balloon was used to predilate the sfa.After balloon angioplasty, a 6mm x 120mm eluvia was inserted into the sfa.After deploying, the eluvia stent foreshortened by at least 20-30mm.This was verified by inserting a 6mm x 120mm balloon as a gauge in angio.It was decided to extend the stent with a 6mm x 40mm eluvia.The same foreshortening of the eluvia stent happened again when the second stent was deployed.Another 6mm x 40mm eluvia was used for extension.The stents were deployed from the proximal to distal sfa.The procedure was successfully completed.No patient complications were reported.It was further reported that "downhill puncture" refers to an antegrade approach that was used to access the 80-90% stenosed and severely calcified target lesion that was located in moderately tortuous anatomy.There was a total of five eluvia stents that were used in this case.It was previously reported that a 6mm x 120mm eluvia stent and a 6mm x 40mm eluvia stent foreshortened; however, it was further clarified that two 6mm x 120mm eluvia stents foreshortened.6mm x 40mm eluvia stents were used for extension of the foreshortened stents.
 
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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 Key18924128
MDR Text Key337905430
Report Number2124215-2024-15906
Device Sequence Number1
Product Code NIU
Combination Product (y/n)Y
Reporter Country CodeSN
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 04/15/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/18/2024
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number24653
Device Catalogue Number24653
Device Lot Number0032677090
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/19/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/02/2023
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient SexMale
Patient RaceAsian
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