BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 3130754 · Received May 24, 2013

    Report

    Report Number
    2024168-2013-03290
    Event Type
    Injury
    Date Received
    May 24, 2013
    Date of Event
    February 1, 2013
    Report Date
    April 29, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION IN THIS CASE, THERE WAS NO REPORTED PRODUCT DEFICIENCY AND THE PRODUCT WAS NOT RETURNED. ADDITIONALLY, PATIENT EFFECT OF HYPERSENSITIVITY, AS LISTED IN THE XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM INSTRUCTIONS FOR USE (IFU), IS A KNOWN ADVERSE EVENT ASSOCIATED WITH CORONARY STENTING PROCEDURE. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS AND THE RELATIONSHIP TO THE DEVICE, IF ANY, CANNOT BE DETERMINED, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURE, DESIGN, OR LABELING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT POST STENTING PROCEDURE WITH AN UNSPECIFIED XIENCE STENT DIFFICULTY WITH THE SENSE OF TASTE HAS BEEN EXPERIENCED. IT IS ALMOST REDUCED AND OFTEN IS A METALLIC TASTE BY MOUTH AND ON THE LIPS. A NEW BLOOD THINNER MEDICATION WAS INTRODUCED AFTER THE SURGERY/PROCEDURE. THE CARDIOLOGIST CHANGED THE MEDICATION TO A GENERIC PLAVIX; HOWEVER, IT HAS NOT RESOLVED THE ISSUE. A PRIOR 7 YEAR STENT PLACEMENT WITH PLAVIX DID NOT YIELD ANY ISSUE SUCH AS THIS. AS THIS WAS NOTICED ABOUT 1 WEEK POST NEW STENT PLACEMENT, IT IS FELT TO BE RELATED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    231210 XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention