BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIENCE PRIME LL EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2671889 · Received July 26, 2012

    Report

    Report Number
    2024168-2012-04764
    Event Type
    Malfunction
    Date Received
    July 26, 2012
    Date of Event
    July 9, 2012
    Report Date
    July 10, 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. GUIDE WIRE: FIELDER FC, (B)(4), GUIDE CATH: LAUNCHER. (B)(4) - AGAINST RESISTANCE-FORCE USED. EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION. FAILURE TO ADVANCE/CROSS THE LESION COULD NOT BE REPLICATED IN A TESTING ENVIRONMENT AS IT WAS BASED ON OPERATIONAL CIRCUMSTANCES. SHAFT SEPARATION/DETACHMENT WAS CONFIRMED. 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 THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. REVIEW OF THE COMPLAINT HISTORY OF THE REPORTED LOT DID NOT INDICATE A MANUFACTURING ISSUE. IT SHOULD BE NOTED THAT THE (B)(4) XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM STATES: DO NOT ADVANCE OR RETRACT THE CATHETER IF RESISTANCE/ANOMALY IS MET DURING MANIPULATION. CONTINUING TO ADVANCE OR RETRACT THE CATHETER MAY RESULT IN DAMAGE TO THE VESSELS, SEPARATION OF THE CATHETER, TIP DAMAGE AND/OR STENT DISLODGEMENT. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A 90% STENOSED, MODERATELY TORTUOUS, HEAVILY CALCIFIED, PROXIMAL-MID, LEFT ANTERIOR STENTING PROCEDURE, AFTER PRE-DILATION, A XIENCE PRIME STENT DELIVERY SYSTEM (SDS) WAS ADVANCED, BUT FAILED TO CROSS THE LESION. REPORTEDLY, THE SDS WAS "PUSHED" AND THE PROXIMAL SHAFT NEAR THE HUB SEPARATED INTO TWO PIECES OUTSIDE THE PATIENTS' ANATOMY. THE XIENCE PRIME PROXIMAL AND DISTAL PIECES OF THE SDS WERE EASILY REMOVED AND ANOTHER XIENCE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT OR NO SIGNIFICANT DELAY IN THE PROCEDURE REPORTED. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XIENCE PRIME LL EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 111144Q

    Patients

    Seq Age Sex Outcome Treatment
    1