BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 3140945 · Received June 3, 2013

    Report

    Report Number
    2024168-2013-03433
    Event Type
    Injury
    Date Received
    June 3, 2013
    Date of Event
    April 16, 2013
    Report Date
    May 6, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P110019
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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. THERE WERE NO REPORTED PRODUCT DEFICIENCIES. THE REPORTED PATIENT EFFECTS OF ATRIAL FIBRILLATION, MYOCARDIAL INFARCTION, PERFORATION, AND THROMBOSIS ARE LISTED IN THE XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM INSTRUCTIONS FOR USE AS KNOWN PATIENT EFFECTS OF CORONARY STENTING PROCEDURES. 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. THE JOSTENT GRAFTMASTER REFERENCED IS BEING FILED UNDER A SEPARATE MANUFACTURING REPORT NUMBER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A PROXIMAL LEFT ANTERIOR DESCENDING (LAD) ARTERY. A 2.75 X 38 MM XIENCE XPEDITION WAS IMPLANTED IN THE PROXIMAL LAD CAUSING A PERFORATION. PRE-DILATATION WAS PERFORMED WITH A NON-ABBOTT BALLOON CATHETER AND A 3.0 X 12 GRAFTMASTER WAS ADVANCED TO THE PERFORATION BUT COULD NOT CROSS. SEVERAL PROLONGED INFLATIONS OF A BALLOON CATHETER LED TO PROXIMAL LAD THROMBOSIS WHICH SEALED THE PERFORATION. THE PATIENT DEVELOPED ATRIAL FIBRILLATION AND WAS TREATED WITH MEDICATION. POST PROCEDURE THE PATIENT HAD COMPLETE HEART BLOCK AND A MASSIVE MYOCARDIAL INFARCTION SECONDARY TO LARGE LAD PERFORATION. ON (B)(6) A PACEMAKER WAS PLACED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    244095 XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 2101641

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization| R| S