BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1963071 · Received January 18, 2011

    Report

    Report Number
    2024168-2011-00370
    Event Type
    Injury
    Date Received
    January 18, 2011
    Date of Event
    December 22, 2010
    Report Date
    December 25, 2010
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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. STENTS: XIENCE V 3X18 ((B)(4), LOT#9042241), XIENCE V 3X15 ((B)(4), LOT#9020461) THERE WAS NO REPORTED PRODUCT DEFICIENCY. ANGINA AND RESTENOSIS ARE KNOWN AS ADVERSE EVENTS OF CORONARY STENTING IN THE XIENCE V INSTRUCTIONS FOR USE (IFU). ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS AND THE RELATIONSHIP, IF ANY, TO THE XIENCE V DEVICE CANNOT BE DETERMINED, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURE OR DESIGN.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA A TRIAL THAT APPROXIMATELY 15 MONTHS POST XIENCE STENT IMPLANTATION IN THE MID RIGHT CORONARY ARTERY (MRCA), THE PATIENT EXPERIENCED CHEST PAIN AND WAS FOUND TO HAVE 80% STENOSIS OF THE PROXIMAL RCA AND 70% IN-STENT RESTENOSIS IN THE MRCA. ON (B)(6) 2010, THE PATIENT UNDERWENT PERCUTANEOUS CORONARY REVASCULARIZATION IN THE MRCA AND TWO NON-TARGET LESIONS. THE PATIENT'S CONDITION RESOLVED ON (B)(6) 2010. THERE WAS NO ADVERSE PATIENT SEQUELA. ALTHOUGH REQUESTED, 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 9042241

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Hospitalization| R