BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2933659 · Received January 29, 2013

    Report

    Report Number
    2024168-2013-00462
    Event Type
    Injury
    Date Received
    January 29, 2013
    Date of Event
    August 23, 2012
    Report Date
    January 8, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THERE WAS NO REPORTED PRODUCT DEFICIENCY AND THE PRODUCT WAS NOT RETURNED. THE REPORTED PATIENT EFFECTS OF ANGINA AND THROMBOSIS, AS LISTED IN THE (B)(4) XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM INSTRUCTIONS FOR USE, ARE KNOWN ADVERSE EVENTS ASSOCIATED WITH CORONARY STENTING PROCEDURES. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE PROCEDURE IN THE MILDLY TORTUOUS, MODERATELY CALCIFIED, MID LEFT ANTERIOR DESCENDING ARTERY (LAD), FOR TREATMENT OF A 90% STENOSIS, PRE-DILATATION WAS PERFORMED. A 3.0X23 RX XIENCE V STENT SYSTEM WAS ADVANCED TO THE TARGET SITE AND THE BALLOON WAS INFLATED TWO TIMES AT 16 ATMOSPHERES FOR 30 SECONDS. INTRAVASCULAR ULTRASOUND (IVUS) WAS PERFORMED AND STENT APPOSITION WAS CONFIRMED. NO FURTHER POST-DILATATION WAS PERFORMED. POST PROCEDURE THE SAME DAY, THE PATIENT EXPERIENCED CHEST PAIN. ANGIOGRAM SHOWED THROMBOSIS IN THE PROXIMAL SEGMENT OF THE STENT. THE THROMBOSIS WAS SUCTIONED AND BALLOON ANGIOPLASTY WAS PERFORMED SUCCESSFULLY. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA. 10,000 MG OF HEPARIN WAS ADMINISTERED DURING THE PROCEDURE. THE PATIENT DOES NOT HAVE A HISTORY OF HEPARIN-INDUCED THROMBOCYTOPENIA. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    39200 XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 1070141

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention 10,000MG HEPARIN