BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1905122 · Received November 22, 2010

    Report

    Report Number
    2024168-2010-02495
    Event Type
    Injury
    Date Received
    November 22, 2010
    Date of Event
    October 22, 2010
    Report Date
    October 28, 2010
    Manufacturer
    AV-CLONMEL
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THERE WAS NO REPORTED PRODUCT DEFICIENCY. DISSECTION IS A KNOWN ADVERSE EVENT AS LISTED IN THE XIENCE V INSTRUCTIONS FOR USE. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS TAKEN UP FOR PERCUTANEOUS TRANSLUMINAL CORONARY ARTERY OF PROXIMAL LEFT ANTERIOR DESCENDING ARTERY LESION. IT WAS PREDILATED AND A XIENCE V 3.5 X 18 MM WAS DEPLOYED AT 16 ATMOSPHERES IN THE LESION. GOOD FLOW WAS ACHIEVED, BUT AFTER WITHDRAWING THE STENT DELIVERY SYSTEM, THE PHYSICIAN OBSERVED A FLOW LIMITING DISSECTION DISTAL TO THE STENT. ANOTHER XIENCE V 3 X 12 MM WAS DEPLOYED TO COVER THE DISSECTION. THE END RESULT WAS GOOD TIMI III FLOW. 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-CLONMEL 0071342

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention