BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2944252 · Received February 5, 2013

    Report

    Report Number
    2024168-2013-00645
    Event Type
    Malfunction
    Date Received
    February 5, 2013
    Date of Event
    January 10, 2013
    Report Date
    January 11, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P110019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    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. EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION. THE STENT DAMAGE AND STENT DISLODGEMENT WERE CONFIRMED. THE BROKEN STENT WAS NOT CONFIRMED, HOWEVER, IT IS MOST LIKELY THAT THE MANGLED AND FLARED STRUTS WERE WHAT WAS INADVERTENTLY DESCRIBED AS BROKEN. BASED ON VISUAL AND DIMENSIONAL ANALYSIS OF THE RETURNED DEVICE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES. THE RESULTS OF THE QUERY OF SIMILAR INCIDENTS IN THE COMPLAINT HANDLING DATABASE FOR THIS LOT DID NOT INDICATE A MANUFACTURING ISSUE. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE PROCEDURE IN THE MODERATELY CALCIFIED/TORTUOUS MID LEFT ANTERIOR DESCENDING ARTERY FOR TREATMENT OF A 90% DE NOVO LESION, A 3.5 X 18 RX XIENCE PRIME STENT SYSTEM WAS ADVANCED WITHOUT RESISTANCE THROUGH A 6F NON-ABBOTT GUIDING CATHETER. DURING ADVANCEMENT, THE STENT DISLODGED FROM THE BALLOON BUT REMAINED ON THE STENT DELIVERY SYSTEM. UPON REMOVAL OF THE STENT SYSTEM FROM THE GUIDING CATHETER, THE STENT WAS NOTED TO BE CRUSHED AND BROKEN. THERE WAS NO RESISTANCE DURING REMOVAL OF THE STENT SYSTEM. THERE WAS NO FORCE APPLIED TO THE STENT SYSTEM DURING ADVANCEMENT OR RETRACTION. THE TARGET LESION WAS SUCCESSFULLY TREATED USING A XIENCE PRIME STENT SYSTEM AND THE SAME GUIDEING CATHETER. THERE WAS NO ADVERSE PATIENT EFFECT. 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
    49202 XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 2083141

    Patients

    Seq Age Sex Outcome Treatment
    1 GUIDE CATHETER: LAUNCHER GUIDE 6F