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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); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/19/2022
Event Type  Injury  
Event Description
It was reported that stent partial deployment and stent fracture occurred.A 6x120, 130 cm eluvia drug-eluting vascular stent system was selected for a superficial femoral artery intervention procedure.The stent was delivered contralaterally; however, once it reached the target location, the stent would not fully deploy.To remove the stent, it was attempted to pull the device out of the patient, but the stent was stretched and ultimately fractured upon removal.Half of the stent remained deployed, and the fractured portion was removed.A non-boston scientific stent graft was used to complete the procedure.There were no patient complications.
 
Manufacturer Narrative
Device analysis by manufacturer: 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 multiple kinks to the outer sheath.The pull rack is separated at the handle and the proximal section did not return for analysis.The stent is separated approximately 8mm from the distal end of the middle sheath and it appears to have been stretched prior to separating.From the proximal end of the stent to the separation is approximately 41mm.The distal section of the stent did not return for analysis.Microscopic examination revealed no additional damages.The lock is no longer on the thumbwheel 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 and stent fracture occurred.A 6x120, 130 cm eluvia drug-eluting vascular stent system was selected for a superficial femoral artery intervention procedure.The stent was delivered contralaterally; however, once it reached the target location, the stent would not fully deploy.To remove the stent, it was attempted to pull the device out of the patient, but the stent was stretched and ultimately fractured upon removal.Half of the stent remained deployed, and the fractured portion was removed.A non-boston scientific stent graft was used to complete the procedure.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
4100 hamline ave n
arden hills, MN 55112
6515810888
MDR Report Key15085066
MDR Text Key296395888
Report Number2134265-2022-07965
Device Sequence Number1
Product Code NIU
UDI-Device Identifier08714729876618
UDI-Public08714729876618
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 09/19/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/22/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date09/21/2023
Device Model Number24657
Device Catalogue Number24657
Device Lot Number0028274405
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received08/24/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/21/2021
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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