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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 Problem Activation, Positioning or Separation Problem (2906)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/29/2023
Event Type  malfunction  
Event Description
It was reported that partial deployment of stent occurred.The 100% stenosed target lesion was located in the mildly tortuous and severely calcified superficial femoral artery (sfa).A 6x120, 130 cm eluvia drug-eluting vascular stent system was selected for a an aortogram with intervention procedure to treat peripheral arterial disease (pad).The stent was only partially deployed with approximately 100 cm of the stent deployed and approximately 20 cm still inside the stent housing.The physician pinned the wire and pulled the stent back out of the body to fully deploy the stent.The wire curled up due to the force on rotating thumb wheel.There were no patient complications, and the case was completed satisfactorily.
 
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 a kink to the outer sheath at the nosecone.Microscopic examination revealed no additional damages.Inspection of the remainder of the device, revealed no other damage or irregularities.Product analysis found damage that could have contributed to the deployment issue.
 
Event Description
It was reported that partial deployment of stent occurred.The 100% stenosed target lesion was located in the mildly tortuous and severely calcified superficial femoral artery (sfa).A 6x120, 130 cm eluvia drug-eluting vascular stent system was selected for a an aortogram with intervention procedure to treat peripheral arterial disease (pad).The stent was only partially deployed with approximately 100 cm of the stent deployed and approximately 20 cm still inside the stent housing.The physician pinned the wire and pulled the stent back out of the body to fully deploy the stent.The wire curled up due to the force on rotating thumb wheel.There were no patient complications, and the case was completed satisfactorily.
 
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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 Key18369345
MDR Text Key331058232
Report Number2124215-2023-72315
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
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 01/22/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/20/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date12/17/2023
Device Model Number24657
Device Catalogue Number24657
Device Lot Number0028704739
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/18/2023
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/02/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/17/2021
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
Patient RaceWhite
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