BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2882756 · Received December 20, 2012

    Report

    Report Number
    2024168-2012-08239
    Event Type
    Injury
    Date Received
    December 20, 2012
    Date of Event
    December 3, 2012
    Report Date
    December 3, 2012
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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 WERE NO REPORTED PRODUCT DEFICIENCIES. THE REPORTED PATIENT EFFECTS OF DISSECTION IS LISTED IN THE XIENCE V 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A MODERATELY TORTUOUS PROXIMAL CIRCUMFLEX STENTING PROCEDURE, AFTER LESION PREPARATION, A 3.5X23MM XIENCE V RX STENT WAS IMPLANTED AND AFTER IMPLANTATION, A DISSECTION WAS NOTED. REPORTEDLY, THE PHYSICIAN FELT THE CAUSE OF THE DISSECTION WAS FROM THE TORTUOSITY OF THE VESSEL AND THE DISEASE IN THE VESSEL AND NOT FROM THE ABBOTT STENT. IT WAS DECIDED TO IMPLANT A STENT DISTALLY TO TREAT THE DISSECTION. THE LESION WAS POST DILATED AND A NON-ABBOTT STENT WAS SUCCESSFULLY IMPLANTED. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE REPORTED. THERE WAS NO ADDITIONAL INFORMATION 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

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention GUIDE CATH: 7F