BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE PRIME LL EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2944467 · Received February 5, 2013

    Report

    Report Number
    2024168-2013-00662
    Event Type
    Injury
    Date Received
    February 5, 2013
    Date of Event
    January 11, 2013
    Report Date
    January 11, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P110019
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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. CONCOMITANT MEDICAL DEVICES: GUIDE WIRE: SION BLUE; GUIDE CATH: HEARTRAIL II. THERE WERE NO REPORTED PRODUCT DEFICIENCIES. THE REPORTED PATIENT EFFECTS OF DISSECTION IS LISTED IN THE XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM INSTRUCTIONS FOR USE AS A KNOWN ADVERSE EVENT. 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 ADDITIONAL XIENCE PRIME 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 90% STENOSED MID AND PROXIMAL LEFT ANTERIOR DESCENDING ARTERY. PRE-DILATATION WAS PERFORMED AND A 3.0 X 38 MM XIENCE PRIME WAS DEPLOYED IN THE DISTAL PORTION OF THE LESION AND A 3.5 X 33 MM XIENCE PRIME WAS DEPLOYED IN THE PROXIMAL PORTION OF THE LESION WHEN A DISSECTION OCCURRED AT THE PROXIMAL END OF THE STENT IMPLANT. A 3.5 X 18 MM XIENCE PRIME WAS DEPLOYED TO SUCCESSFULLY SEAL THE DISSECTION. WHEN ANGIOGRAPHY WAS PERFORMED, A DISSECTION WAS OBSERVED IN THE LEFT MAIN. A 3.5 X 12 MM XIENCE PRIME WAS ADVANCED TO THE LEFT MAIN; HOWEVER, WHEN NEGATIVE PRESSURE WAS APPLIED PRIOR TO PRESSURIZING, BLOOD CAME BACK INTO THE INFLATION LUMEN. THE CATHETER WAS REMOVED AND A NEW 3.5 X 12 MM XIENCE PRIME WAS DEPLOYED TO SEAL THE DISSECTION AND COMPLETE THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    49297 XIENCE PRIME LL EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 2051741

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention