BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 4960591 · Received August 3, 2015

    Report

    Report Number
    2024168-2015-04374
    Event Type
    Injury
    Date Received
    August 3, 2015
    Date of Event
    July 15, 2015
    Report Date
    July 16, 2015
    Manufacturer
    AV-TEMECULA-CT
    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). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THERE WAS NO REPORTED DEVICE MALFUNCTION AND THE PRODUCT WAS NOT RETURNED. DISSECTION IS LISTED IN THE XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEMS INSTRUCTIONS FOR USE AS A KNOWN PATIENT EFFECT OF CORONARY STENTING PROCEDURES. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED, THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING. A REVIEW OF THE LOT HISTORY RECORD IDENTIFIED NO MANUFACTURING NONCONFORMITIES ISSUED TO THE REPORTED LOT THAT WOULD HAVE CONTRIBUTED TO THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A DE NOVO LESION IN THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY WITH HEAVY TORTUOSITY, MILD CALCIFICATION AND 95% STENOSIS, PRE-DILATATION WAS PERFORMED WITH A 1.2X6MM BALLOON. A 2.25X18MM RX XIENCE V STENT DELIVERY SYSTEM WAS ADVANCED AND THE STENT DEPLOYED; HOWEVER, AN EDGE DISSECTION OCCURRED. A XIENCE PRIME STENT WAS IMPLANTED TO COVER THE DISSECTION. THERE WAS NO ADVERSE PATIENT SEQUELAE AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    504934 XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 4091541

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention