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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 Problems 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 10/24/2022
Event Type  malfunction  
Event Description
It was reported that stent partial deployment occurred, resulting in a cancelled procedure.The 90% stenosed target lesion was located in a severely tortuous and severely calcified superficial femoral artery.A 7x120, 130 cm eluvia drug-eluting vascular stent system was selected to treat the peripheral arterial disease in the percutaneous angioplasty procedure.The lesion was pre-dilated with a coyote balloon.When deploying the stent, it was noted that the thumbwheel was rotated using a strong force and the pull grip was used once the white arrow was seen.However, when deploying the stent, it failed to deploy.It was noticed that the stent had stretched during the attempted placement, indicating that it had partially deployed.The procedure was not completed due to this event.There were no patient complications reported.
 
Manufacturer Narrative
Device evaluated 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 that the stent is partially deployed 3cm from the distal end of the middle sheath.The partially deployed stent appears to be separated and only measures 9.4cm long.The distal section of the separated stent did not return for analysis.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.Product analysis found damage that would have contributed to the reported event.
 
Event Description
It was reported that stent partial deployment occurred, resulting in a cancelled procedure.The 90% stenosed target lesion was located in a severely tortuous and severely calcified superficial femoral artery.A 7x120, 130 cm eluvia drug-eluting vascular stent system was selected to treat the peripheral arterial disease in the percutaneous angioplasty procedure.The lesion was pre-dilated with a coyote balloon.When deploying the stent, it was noted that the thumbwheel was rotated using a strong force and the pull grip was used once the white arrow was seen.However, when deploying the stent, it failed to deploy.It was noticed that the stent had stretched during the attempted placement, indicating that it had partially deployed.The procedure was not completed due to this event.There were no patient complications reported.
 
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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 Key15809092
MDR Text Key305423802
Report Number2124215-2022-45965
Device Sequence Number1
Product Code NIU
Combination Product (y/n)Y
Reporter Country CodeJA
PMA/PMN Number
P180011
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative,Distributor
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 11/30/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date07/27/2023
Device Model Number24653
Device Catalogue Number24653
Device Lot Number0027852614
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 10/24/2022
Initial Date FDA Received11/16/2022
Supplement Dates Manufacturer Received11/30/2022
Supplement Dates FDA Received11/30/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/27/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient SexMale
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