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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 Entrapment of Device (1212); Activation, Positioning or Separation Problem (2906)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/17/2023
Event Type  malfunction  
Event Description
It was reported that the stent partially deployed, and the catheter became stuck on the guidewire.An eluvia eu, 7x120, 130 cm was selected for use in the superficial femoral artery (sfa) for the endovascular therapy procedure.The target vessel in the sfa was reported to be 100% stenosed with mild tortuosity and calcification.The lesion was accessed via an antegrade approach from the right femoral artery and was predilated using a non-bsc balloon catheter.The eluvia delivery system was advanced to the sfa and deployment was attempted.When the pull grip was utilized, approximately 4/5 of the stent did not deploy.When the thumbwheel was rotated continuously, the remainder of the stent deployed suddenly.It was attempted to remove the non-bsc guidewire from the eluvia catheter, but this was unsuccessful.Both the delivery system and the non-bsc catheter were removed together as one unit.The procedure was completed and there were no adverse consequences reported to the patient.
 
Manufacturer Narrative
Device media analysis: returned product consisted of an eluvia self-expanding stent system 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 kinked at the nosecone.Microscopic examination revealed no additional damages.The stent was deployed and did not return for analysis.The handle was x-rayed, and 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 froze on wire.
 
Event Description
It was reported that the stent partially deployed, and the catheter became stuck on the guidewire.An eluvia eu, 7x120, 130 cm was selected for use in the superficial femoral artery (sfa) for the endovascular therapy procedure.The target vessel in the sfa was reported to be 100% stenosed with mild tortuosity and calcification.The lesion was accessed via an antegrade approach from the right femoral artery and was predilated using a non-bsc balloon catheter.The eluvia delivery system was advanced to the sfa and deployment was attempted.When the pull grip was utilized, approximately 4/5 of the stent did not deploy.When the thumbwheel was rotated continuously, the remainder of the stent deployed suddenly.It was attempted to remove the non-bsc guidewire from the eluvia catheter, but this was unsuccessful.Both the delivery system and the non-bsc catheter were removed together as one unit.The procedure was completed and there were no adverse consequences reported to the patient.
 
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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 Key16386211
MDR Text Key309661344
Report Number2124215-2023-06704
Device Sequence Number1
Product Code NIU
Combination Product (y/n)Y
Reporter Country CodeJA
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 03/16/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/16/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number24653
Device Catalogue Number24653
Device Lot Number0029618839
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/21/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/26/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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