BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2230049 · Received August 31, 2011

    Report

    Report Number
    2024168-2011-06055
    Event Type
    Injury
    Date Received
    August 31, 2011
    Date of Event
    August 8, 2011
    Report Date
    August 8, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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 WAS NO REPORTED PRODUCT DEFICIENCY AND THE PRODUCT WAS NOT RETURNED. PERFORATION, NAUSEA, AND PAIN ARE KNOWN ADVERSE EVENTS AS LISTED IN THE XIENCE V INSTRUCTIONS FOR USE. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS AND THE RELATIONSHIP, IF ANY, TO THE DEVICE COULD NOT 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 AFTER PREDILATATION WAS PERFORMED ON THE DISTAL AND MID LEFT ANTERIOR DESCENDING ARTERY (LAD), ONE XIENCE V WAS PLACED DISTALLY. A 2.75X18 MM XIENCE V WAS PLACED IN THE MID LAD, AFTER WHICH A PERFORATION WAS NOTED IN THE VESSEL. A 3.0X28 MM XIENCE V STENT WAS PLACED FOR TREATMENT OF THE PERFORATION ALONG WITH LONG INFLATIONS OF THE STENT DELIVERY SYSTEM BALLOON. PERICARDIOCENTESIS WAS PERFORMED FOR THE BLEEDING INTO THE PERICARDIUM. THE PATIENT EXPERIENCED NAUSEA AND A PINCH LIKE PAIN WHEN THE PERFORATION OCCURRED. THE PATIENT IS REPORTED TO BE WELL AFTER THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    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-CT 1060141

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention STENT: XIENCE V 2.5X28 MM