BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1922809 · Received December 13, 2010

    Report

    Report Number
    2024168-2010-02685
    Event Type
    Injury
    Date Received
    December 13, 2010
    Date of Event
    October 29, 2010
    Report Date
    November 18, 2010
    Manufacturer
    AV-TEMECULA
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, 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. (B)(4): NO PREDILATATION PRIOR TO STENTING. STENT: 3.0 X 23 MM XIENCE V (1009541-23/8061661), 3.0 X 28 MM XIENCE V (1009541-28/8053042). THERE WAS NO REPORTED PRODUCT DEFICIENCY. THE REPORTED RE-STENOSIS, AND ISCHEMIA ARE LISTED IN THE INSTRUCTIONS FOR USE (IFU) AS KNOWN ADVERSE EVENTS ASSOCIATED WITH CORONARY STENTING AND ARE NOT NECESSARILY AN INDICATION OF A PRODUCT QUALITY DEFICIENCY. IT WAS REPORTED THAT THE XIENCE V STENT WAS DIRECT STENTED (IMPLANTED WITH NO PRE-DILATATION). IT SHOULD BE NOTED THAT THE IFU STATES TO PRE-DILATE THE LESION WITH A PTCA CATHETER OF APPROPRIATE LENGTH AND DIAMETER FOR THE VESSEL/LESION TO BE TREATED. LIMIT THE LONGITUDINAL LENGTH OF PRE-DILATATION BY THE PTCA BALLOON TO AVOID CREATING A REGION OF VESSEL INJURY THAT IS OUTSIDE THE BOUNDARIES OF THE XIENCE V STENT. THE DIRECT STENTING (NO PRE-DILATATION) DOES NOT APPEAR TO HAVE CONTRIBUTED TO THE REPORTED PATIENT EFFECTS AS THE PATIENT EFFECTS WERE REPORTED APPROXIMATELY 2 YEAR POSTS TO THE PROCEDURE. 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 DEFICIENCY WITH RESPECT TO MANUFACTURING, DESIGN OR LABELING AND THE TREATMENTS APPEAR TO BE RELATED TO THE OPERATIONAL CONTEXT OF THE PROCEDURE. THE 3.0 X 23 MM XIENCE V (1009541-23/8061661), AND THE 3.0 X 28 MM XIENCE V (1009541-28/8053042), INDICATED ARE BEING FILED UNDER SEPARATE MFR#S.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA CLINICAL TRIAL THAT THE INDEX PROCEDURE TOOK PLACE ON (B)(6) 2008, NO PREDILATATION WAS PERFORMED PRIOR TO STENTING. ON (B)(6) 2010, THE PATIENT WAS EXPERIENCING RECURRENT ISCHEMIA. ANGIOGRAPHY WAS PERFORMED TO INVESTIGATE LOW CARDIAC OUTPUT AND REVEALED AN OCCLUDED RIGHT CORONARY ARTERY (RCA). THE PATIENT UNDERWENT PERCUTANEOUS CORONARY INTERVENTION AND THREE XIENCE V STENTS WERE IMPLANTED TO COVER THE 60 MM COMPLEX IN-STENT RESTENOSIS OF THE THREE PREVIOUSLY PLACED XIENCE V STENTS. STENOSIS REMAINING WAS 0% AND A TIMI 3 FLOW WAS RESTORED AT THE END OF A SUCCESSFUL PROCEDURE. NO ADDITIONAL INFORMATION WAS 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 8060261

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Hospitalization| R CONCOMITANT MEDICAL PRODUCTS