BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 3935325 · Received July 15, 2014

    Report

    Report Number
    2024168-2014-04526
    Event Type
    Injury
    Date Received
    July 15, 2014
    Date of Event
    June 20, 2014
    Report Date
    June 20, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - AGAINST RESISTANCE. THE DEVICE WAS RETURNED FOR ANALYSIS. THE LOOSE STENT WAS UNABLE TO BE CONFIRMED AS IT WAS DEPLOYED IN THE PATIENT'S ANATOMY. THE FAILURE TO ADVANCE COULD NOT BE REPLICATED IN A TESTING ENVIRONMENT AS IT WAS BASED ON OPERATIONAL CIRCUMSTANCES. BASED ON A VISUAL INSPECTION 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. A QUERY/REVIEW OF THE COMPLAINT HISTORY OF THE REPORTED LOT DID NOT INDICATE A MANUFACTURING ISSUE. IT SHOULD BE NOTED THE XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM INSTRUCTIONS FOR USE (IFU)) STATES: SHOULD ANY RESISTANCE BE FELT AT ANY TIME DURING EITHER LESION ACCESS OR REMOVAL OF THE DELIVERY SYSTEM POST-STENT IMPLANTATION, THE ENTIRE SYSTEM SHOULD BE REMOVED AS A SINGLE UNIT. BASED ON THE REVIEWED INFORMATION, NO PRODUCT DEFICIENCY WAS IDENTIFIED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 95% STENOSED, MILDLY CALCIFIED LESION IN THE MILDLY TORTUOUS MID RIGHT CORONARY ARTERY (RCA). PRE-DILATATION WAS PERFORMED USING A 2.0X8MM MINI TREK BALLOON DILATATION CATHETER (BDC). THE 4.0X15MM XIENCE V STENT DELIVERY SYSTEM (SDS) FAILED TO CROSS THE LESION REPORTEDLY DUE TO INTERACTIONS WITH THE PATIENT'S ANATOMY AND FORCE WAS APPLIED. AS THE STENT IMPLANT APPEARED TO BE LOOSE ON THE BALLOON, THE DECISION WAS MADE TO DEPLOY THE STENT IMPLANT IN AN UNINTENDED SITE, IN HEALTHY TISSUES. THE DECISION WAS MADE TO STOP THE PROCEDURE AND NO FURTHER TREATMENT WAS PERFORMED. THERE WERE NO REPORTED ADVERSE PATIENT SEQUELA AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. IT IS UNKNOWN IF FUTURE TREATMENT IS PLANNED FOR THE PATIENT. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    413819 XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 2102341

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Other