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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); Material Deformation (2976)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/29/2022
Event Type  malfunction  
Event Description
It was reported that the stent partially deployed and stretched.A 7x120, 130 cm eluvia drug-eluting vascular stent system was selected for use in the superficial femoral artery.The 75% stenosed target lesion was moderately calcified and located in moderately tortuous anatomy.During the procedure, the thumb wheel and pull grip were used to deploy the stent, but it could not be fully deployed.The system was pulled, and the stent was stretched and placed.The procedure was completed.No patient complications were reported.
 
Manufacturer Narrative
Device eval by manufacturer: returned product consisted of an eluvia self-expanding stent system with an unknown 0.014" 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 sheath was kinked at the nosecone.Microscopic examination revealed no additional damages.The stent was deployed and was not returned 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 stent deformation.
 
Event Description
It was reported that the stent partially deployed and stretched.A 7x120, 130 cm eluvia drug-eluting vascular stent system was selected for use in the superficial femoral artery.The 75% stenosed target lesion was moderately calcified and located in moderately tortuous anatomy.During the procedure, the thumb wheel and pull grip were used to deploy the stent, but it could not be fully deployed.The system was pulled, and the stent was stretched and placed.The procedure was completed.No patient complications were reported.It was further reported that this was a contralateral approach.Approximately half of the stent was deployed with the thumbwheel, and the remaining two-thirds was deployed with the pull grip, but it was not possible to deploy it all.Therefore, the whole system was pulled to deploy the stent.
 
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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 Key15655168
MDR Text Key304201862
Report Number2124215-2022-42620
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 Foreign,Health Professional,Company Representative,Distributor
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 11/21/2022
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 Date02/18/2024
Device Model Number24653
Device Catalogue Number24653
Device Lot Number0029102124
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/18/2022
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 09/30/2022
Initial Date FDA Received10/21/2022
Supplement Dates Manufacturer Received10/26/2022
Supplement Dates FDA Received11/21/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/18/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
GUIDE CATHETER: DESTINATION; GUIDE CATHETER: DESTINATION; GUIDEWIRE: GLADIUS; GUIDEWIRE: GLADIUS; MICRO CATHETER: ALUMET; MICRO CATHETER: ALUMET
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