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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
Medical Device Problem Code Detachment of Device or Device Component (2907)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 04/30/2021
Type of Reportable Event Serious Injury
Event or Problem Description
It was reported that the tip of the device came off in the patient an had to be snared to remove.A 6x60x130 eluvia self-expanding drug eluting stent was selected for use in a procedure.During the procedure, the tip of the eluvia catheter came off in the patient.The physician snared the device.The patient was reported as doing fine.
 
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Brand Name
ELUVIA DRUG-ELUTING VASCULAR STENT SYSTEM
Common Device Name
STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key11884502
Report Number2134265-2021-06707
Device Sequence Number14351687
Product Code NIU
UDI-Device Identifier08714729876588
UDI-Public08714729876588
Combination Product (Y/N)Y
Initial Reporter CountryCA
PMA/510(K) Number
P180011
Number of Events Summarized1
Summary Report (Y/N)N
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 05/26/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Expiration Date01/09/2023
Device Model Number24657
Device Catalogue Number24657
Device Lot Number0026675045
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 05/03/2021
Initial Report FDA Received Date05/26/2021
Patient Sequence Number1
Outcome Attributed to Adverse Event Other; Required Intervention;
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