BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2923350 · Received January 22, 2013

    Report

    Report Number
    2024168-2013-00348
    Event Type
    Malfunction
    Date Received
    January 22, 2013
    Date of Event
    December 18, 2012
    Report Date
    December 25, 2012
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P110019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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. DILATATION CATHETER: TENKU. GUIDE WIRE: SION BLUE. IT IS INDICATED THAT THE DEVICE IS NOT RETURNING FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. 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 XIENCE PRIME MET RESISTANCE DURING ADVANCEMENT AND WAS UNABLE TO CROSS THE PREDILATED, MILDLY TORTUOUS, MODERATELY CALCIFIED, 90% STENOSED TARGET LESION IN THE PROXIMAL TO MID LEFT ANTERIOR DESCENDING CORONARY ARTERY. THE XIENCE PRIME WAS REMOVED WITH SOME RESISTANCE AND THE PROCEDURE WAS COMPLETED WITH A NON-ABBOTT STENT. IT WAS NOTED THAT THE XIENCE PRIME APPEARED SLIGHTLY EXPANDED ALTHOUGH THE STENT DELIVERY SYSTEM WAS NOT PRESSURIZED. THERE WERE NO ADVERSE PATIENT EFFECTS. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    30494 XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 2082841

    Patients

    Seq Age Sex Outcome Treatment
    1 SEE H10 FOR CONCOMITANT MEDICAL DEVICES