BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2252268 · Received September 16, 2011

    Report

    Report Number
    2024168-2011-06373
    Event Type
    Injury
    Date Received
    September 16, 2011
    Date of Event
    April 20, 2011
    Report Date
    August 22, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). FACTORS THAT MAY CONTRIBUTE TO STENT FRACTURE INCLUDE, BUT ARE NOT LIMITED TO, PROCESSING AND/OR HANDLING IN MANUFACTURING, HANDLING DURING PREPARATION FOR USE, LESION CHARACTERISTICS, PROCEDURAL TECHNIQUE, PRODUCT SIZE SELECTION, SEVERE TORQUING OR KINKING OF STENT (MATERIAL STRESS/ FATIGUE) OR INTERACTION WITH THE ACCESSORY DEVICES, LESION AND/OR ANATOMY. FATIGUE FROM CARDIAC DYNAMICS AND MOTION MAY ALSO CONTRIBUTE TO STENT FRACTURE DURING OR AFTER THE PROCEDURE. IN THIS CASE, THE STENT FRACTURE WAS NOT NOTED AT THE TIME OF STENT IMPLANT, SUGGESTING THAT THE NOTED DAMAGE OCCURRED POST PROCEDURE. ISCHEMIA AND RESTENOSIS, AS LISTED IN THE XIENCE V INSTRUCTIONS FOR USE (IFU), IS A KNOWN ADVERSE EVENT ASSOCIATED WITH CORONARY STENTING AND IS NOT NECESSARILY AN INDICATION OF A PRODUCT QUALITY DEFICIENCY. IN THIS CASE, THE REPORTED STENT FRACTURE POSSIBLY CONTRIBUTED TO THE REPORTED RESTENOSIS. HOWEVER, A CONCLUSIVE CAUSE CANNOT BE DETERMINED FOR THE REPORTED PATIENT EFFECTS AND THEIR RELATIONSHIP TO THE DEVICE, IF ANY. A REVIEW OF THE DEVICE LOT HISTORY RECORD DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS FOR THIS LOT RELEVANT TO THIS REPORT. ADDITIONALLY, A QUERY OF THE COMPLAINT-HANDLING DATABASE WAS PERFORMED AND THERE HAVE BEEN NO SIMILAR INCIDENTS REPORTED FOR STENT FRACTURE FOR THIS LOT. BASED ON THIS INVESTIGATION, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. ALL STENT DELIVERY SYSTEMS ARE SUBJECTED TO A VISUAL INSPECTION. IN ADDITION, A QUALITY CONTROL AUDIT INSPECTION IS USED TO VERIFY THE PRODUCT QUALITY.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA TRIAL THAT THE INDEX PROCEDURE WAS (B)(6) 2008, POST ROTABLATOR, WHEN TWO NON-ABBOTT DRUG ELUTING STENTS WERE IMPLANTED IN THE PROXIMAL AND ANTERIOR DESCENDING RIGHT CORONARY ARTERY (RCA) AND THE LEFT MAIN. ON (B)(6) 2010, STENT STENOSIS WAS CONFIRMED FOR THE MID RCA TARGET VESSEL AND DISTAL RCA TARGET LESION. ON (B)(6) 2010, POST ROTABLATOR, XIENCE V STENTS WERE IMPLANTED IN THE HEAVILY CALCIFIED, MID AND DISTAL RCA LESIONS. ON (B)(6) 2011, DURING A SCHEDULED FOLLOW UP VISIT, THE PATIENT WAS NON-SYMPTOMATIC FOR OBSERVED ISCHEMIA. THE 3.0 MM X 15 MM XIENCE V STENT IMPLANTED IN THE DISTAL RCA WAS CONFIRMED TO BE OCCLUDED AND REVASCULARIZATION WITH A 3.5 MM X 24 MM NON-ABBOTT STENT WAS PERFORMED. THERE WAS NO ANOMALY NOTED IN THE 3.5 MM X 18 MM XIENCE V STENT. IT WAS CONFIRMED BY INTRAVASCULAR ULTRASOUND (IVUS) AND ANGIOGRAPHY THAT THE STENOSIS MAY HAVE OCCURRED DUE TO FRACTURE OF THE STENT. THOUGH REQUESTED, 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-CT 9121741

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization| R