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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 Difficult to Advance (2920); Device Contamination with Chemical or Other Material (2944)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/28/2022
Event Type  malfunction  
Event Description
It was reported that foreign material was found on the device.A 6x40, 130 cm eluvia drug-eluting vascular stent system was selected for use in a percutaneous transluminal angioplasty and stenting procedure in the superficial femoral artery.During the procedure outside the patient, an attempt was made to use the device, but there were problems with the catheter, and a white drug particle was observed on the stent.The device was exchanged for another of the same.No patient complications were reported.
 
Event Description
It was reported that foreign material was found on the device.A 6x40, 130 cm eluvia drug-eluting vascular stent system was selected for use in a percutaneous transluminal angioplasty and stenting procedure in the superficial femoral artery.During the procedure outside the patient, an attempt was made to use the device, but there were problems with the catheter, and a white drug particle was observed on the stent.The device was exchanged for another of the same.No patient complications were reported.It was further reported that there was no foreign material.No white drug particle was observed.When the catheter was advanced, resistance was felt.
 
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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
jeff wallner
4100 hamline ave n
arden hills, MN 55112
6515811560
MDR Report Key15854590
MDR Text Key307318155
Report Number2124215-2022-48073
Device Sequence Number1
Product Code NIU
Combination Product (y/n)Y
Reporter Country CodeKS
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 03/31/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/23/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date12/10/2023
Device Model Number24653
Device Catalogue Number24653
Device Lot Number0028659953
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/21/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/10/2021
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
Patient Age77 YR
Patient SexFemale
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