BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1912649 · Received December 2, 2010

    Report

    Report Number
    2024168-2010-02575
    Event Type
    Injury
    Date Received
    December 2, 2010
    Date of Event
    November 8, 2010
    Report Date
    November 9, 2010
    Manufacturer
    AV-TEMECULA
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THERE WAS NO REPORTED PRODUCT DEFICIENCY. THE REPORTED HEMORRHAGE IS A KNOWN ADVERSE EVENT LISTED IN THE XIENCE V INSTRUCTIONS FOR USE. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECT 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.

    Additional Manufacturer Narrative · 1

    (B)(4). THE STENT REMAINS IN THE PATIENT. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE XIENCE V STENT WAS IMPLANTED ON (B)(6) 2010. THE PATIENT WAS ENROLLED IN THE HCRI DAPT TRIAL AND WAS PLACED ON DUAL ANTI-PLATELET THERAPY. ON (B)(6) 2010 THE PATIENT PRESENTED WITH A GI BLEED. X-RAY SHOWED ARTERIOVENOUS MALFORMATION OF PATIENT'S GUT. BLOOD TRANSFUSION STARTED. THE PATIENT WAS TREATED WITH APPROXIMATELY 12 UNITS OF BLOOD (2 UNITS PLATELETS EACH DAY). BLOOD CELLS STILL CONTINUING TO DROP, SO THE PATIENT WAS REMOVED FROM PLAVIX WITH NO IMPROVEMENT. THE PATIENT WAS THEN REMOVED FROM ASPIRIN. THE PATIENT WAS TESTED FOR POSSIBLE HEPARIN INDUCED THROMBOCYTOPENIA (ALLERGIC REATION TO HEPARIN) OR HEMOPHILIA TO DETERMINE THE EXACT TYPE OF BLOOD DISORDER. THE PLATELET STUDIES ALL CAME BACK NEGATIVE. THE HEMATOLOGIST THINKS THAT THE PLAVIX AND ASPIRIN AGGRAVATED A TENDENCY TO THROMBOCYTOPENIA THAT MAY HAVE EXISTED PRIOR TO THE PERCUTANEIOUS CORONARY INTERVENTION. HE HAD A PRE-CATH LAB PLATELET COUNT OF 106. THE PATIENT WAS ENTIRELY ASYMPTOMATIC DURING THE LAST WEEK OF HIS HOSPITALIZATION AND WAS DISCHARGED ON (B)(6) 2010 WITH A PLATELET COUNT OF 70 AND HEMOGLOBIN ABOVE 10. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE CLINIC FOR AN ABLATION. THE PATIENT RECEIVED THERAPY. WHEN THE DEVICE WAS INTERROGATED,THE DEVICE PRESENTED IN HW RESET WITH BVVI PACING AND NO DEFIB FUNCTION. THE DEVICE WAS EXPLANTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Hospitalization| R