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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 Difficult or Delayed Positioning (1157); Difficult to Remove (1528); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/02/2023
Event Type  malfunction  
Event Description
It was reported that the stent delivery system was difficult to remove after stent deployment.This 7x120, 130 cm eluvia drug-eluting vascular stent system was selected for use in a stenting procedure.The diffusely diseased, mildly calcified lesion was located in the superficial femoral artery.A contralateral approach was used.After laser atherectomy of the lesion, the eluvia stent was attempted to be deployed over a non-boston scientific guidewire.However, the thumb wheel stopped working after three fourths of the stent was deployed in the lesion.The pull grip was used, and the remainder of the stent was deployed.Then the physician removed one fourth of the catheter into the guide sheath when it became stuck.The physician cut the deployment handle from the catheter and the catheter and guidewire were successfully removed.There were no patient complications.There is no product available for return.
 
Event Description
It was reported that the stent delivery system was difficult to remove after stent deployment.This 7x120, 130 cm eluvia drug-eluting vascular stent system was selected for use in a stenting procedure.The diffusely diseased, mildly calcified lesion was located in the superficial femoral artery.A contralateral approach was used.After laser atherectomy of the lesion, the eluvia stent was attempted to be deployed over a non-boston scientific guidewire.However, the thumb wheel stopped working after three fourths of the stent was deployed in the lesion.The pull grip was used, and the remainder of the stent was deployed.Then the physician removed one fourth of the catheter into the guide sheath when it became stuck.The physician cut the deployment handle from the catheter and the catheter and guidewire were successfully removed.There were no patient complications.There is no product available for return.
 
Manufacturer Narrative
Device eval by manufacturer: upon receipt at our post market quality assurance laboratory, this eluvia self-expanding stent system was returned with an unknown 0.014-inch guidewire stuck in the device.The outer sheath, tip, inner sheath, and the remainder of the device were checked for damage.Visual examination revealed that the outer sheath was separated 3mm from the nosecone.The pull rack was separated at the handle and the proximal section of the pull was missing.There were multiple kinks along the outer sheath.The inner liner was kinked 13cm from the tip.Microscopic examination revealed no additional damages.The stent was deployed and was not returned for analysis.X ray examination of the handle showed the proximal inner was prolapsed.Inspection of the remainder of the device revealed no other damage or irregularities.Product analysis found damage that would have contributed to the deployment issue and difficulty to remove.
 
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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 Key17968085
MDR Text Key326080627
Report Number2124215-2023-54886
Device Sequence Number1
Product Code NIU
UDI-Device Identifier08714729876731
UDI-Public08714729876731
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 12/20/2023
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 Date01/11/2024
Device Model Number24657
Device Catalogue Number24657
Device Lot Number0028752598
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 10/02/2023
Initial Date FDA Received10/19/2023
Supplement Dates Manufacturer Received12/14/2023
Supplement Dates FDA Received12/21/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/11/2022
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
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