BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1251687 · Received December 2, 2008

    Report

    Report Number
    2024168-2008-01266
    Event Type
    Injury
    Date Received
    December 2, 2008
    Date of Event
    November 4, 2008
    Report Date
    November 6, 2008
    Manufacturer
    ABBOTT VASCULAR - CARDIAC THERAPIES
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS AND CONCLUSION SUMMATION - PRODUCT PERFORMANCE ENGINEERING REVIEWED THE INCIDENT. DISSECTION, AS LISTED IN THE IFU, IS A KNOWN ADVERSE EVENT ASSOCIATED WITH STENTING AND IS NOT NECESSARILY AN INDICATION OF A PRODUCT ISSUE. DISSECTION CAN BE INFLUENCED BY SEVERAL FACTORS, INCLUDING BUT NOT LIMITED TO, LESION CHARACTERISTICS, PROCEDURAL TECHNIQUE, AND DEVICE SIZE SELECTION. THE IFU STATES, "IMPLANTING A STENT MAY LEAD TO DISSECTION OF THE VESSEL DISTAL AND/OR PROXIMAL TO THE STENT AND MAY CAUSE ACUTE CLOSURE OF THE VESSEL REQUIRING ADDITIONAL INTERVENTION (CABG, FURTHER DILATATION, PLACEMENT OF ADDITIONAL STENTS..)." A CONCLUSIVE ROOT CAUSE FOR THE PATIENT EFFECT, AND THE RELATIONSHIP TO THE DEVICE, IF ANY, CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    REPORTING STATUS: SERIOUS INJURY - MEDICAL INTERVENTION. REPORTING RATIONALE: DISSECTION REQUIRING MEDICAL INTERVENTION. DEVICE ISSUE: NO DEVICE MALFUNCTION HAS BEEN REPORTED. IT WAS REPORTED VIA A TRIAL THAT A TYPE A DISTAL DISSECTION OCCURRED IN 2008, DURING A PROCEDURE IN THE PROXIMAL RCA AFTER IMPLANTATION OF THE FIRST STUDY STENT. THE DISSECTION RESOLVED WITH IMPLANTATION OF ANOTHER STUDY STENT. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM NIQ ABBOTT VASCULAR - CARDIAC THERAPIES NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention STENT: XIENCE V (1009527-8