BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 3021687 · Received March 26, 2013

    Report

    Report Number
    2024168-2013-01732
    Event Type
    Injury
    Date Received
    March 26, 2013
    Date of Event
    February 18, 2013
    Report Date
    March 1, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE CUSTOMER REPORTED THE DEVICE REMAINS IN THE PATIENT. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). THERE WAS NO REPORTED PRODUCT DEFICIENCY AND THE PRODUCT WAS NOT RETURNED. THE REPORTED PATIENT EFFECTS OF STENOSIS, AS LISTED IN THE XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM INSTRUCTIONS FOR USE, 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 OR DESIGN.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2008, TWO XIENCE V STENTS WERE IMPLANTED IN A DE NOVO, MID, LEFT ANTERIOR DESCENDING ARTERY AND APPROXIMATELY 4 1/2 YEARS LATER, THE PATIENT HAD AN ABNORMAL STRESS TEST ON (B)(6) 2013 AS AN OUTPATIENT IN THE PHYSICIAN'S OFFICE AND ON AN ANGIOGRAM, THERE WAS REPORTED WORSENING OF THE PATIENT'S CORONARY ARTERY DISEASE (CAD). THE PATIENT WAS HOSPITALIZED FROM (B)(6) 2013. THE PATIENT HAD A SUCCESSFUL PERCUTANEOUS INTERVENTION (PCI) TO THE LAD, CIRCUMFLEX, AND THE LEFT MAIN OBTAINING COMPLETE REVASCULARIZATION. THE SYMPTOMS RESOLVED ON (B)(6) 2013. THE PATIENT WAS DISCHARGED HOME ON (B)(6) 2013. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Description of Event or Problem · 1

    SUBSEQUENT INFORMATION RECEIVED TODAY THAT THE XIENCE V STENTS WERE PATENT AND THAT THE PATIENT EXPERIENCED WORSENING CHEST PAINS, WORSENING DYSPNEA, WORSENING FATIGUE, AND EXERCISE INTOLERANCE. THERE WAS NO EDGE STENOSIS NOTED ON EITHER XIENCE V STENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    123400 XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 8041841

    Patients

    Seq Age Sex Outcome Treatment
    1 104 YR Hospitalization| R