BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2823233 · Received November 7, 2012

    Report

    Report Number
    2024168-2012-07041
    Event Type
    Malfunction
    Date Received
    November 7, 2012
    Date of Event
    October 15, 2012
    Report Date
    October 16, 2012
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION. THE RESISTANCE BETWEEN THE STENT DELIVERY SYSTEM AND GUIDE WIRE WAS NOT CONFIRMED. BASED ON VISUAL, FUNCTIONAL, 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 THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW UP WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A BALANCE MIDDLEWEIGHT (BMW) GUIDE WIRE CROSSED THE LESION LOCATED IN THE RIGHT CORONARY ARTERY SUCCESSFULLY. ALTHOUGH THE 3.0 X 15 MM XIENCE V STENT DELIVERY SYSTEM (SDS) WAS FLUSHED PRIOR TO THE ATTEMPT TO ADVANCE THE SDS ON THE GUIDE WIRE, THE SDS WOULD NOT ADVANCE ON THE GUIDE WIRE OUTSIDE THE PATIENT. SOME RESISTANCE WAS ALSO FELT DURING REMOVAL OF THE SDS FROM THE GUIDE WIRE. A NEW 3.0 X 15 MM XIENCE V SDS WAS ABLE TO ADVANCE OVER THE SAME BMW GUIDE WIRE WITHOUT ISSUE AND THE STENT IMPLANT WAS DEPLOYED SUCCESSFULLY TO COMPLETE THE CASE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE OR ADVERSE PATIENT EFFECTS REPORTED. 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 2051741

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR GUIDE WIRE: BMW