BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 3072799 · Received April 23, 2013

    Report

    Report Number
    2024168-2013-02489
    Event Type
    Injury
    Date Received
    April 23, 2013
    Date of Event
    April 15, 2013
    Report Date
    April 15, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    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. (B)(4). 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 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 XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM INSTRUCTIONS FOR USE 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. FAILURE TO FOLLOW THESE STEPS AND/OR APPLYING EXCESSIVE FORCE TO THE DELIVERY SYSTEM CAN POTENTIALLY RESULT IN LOSS OR DAMAGE TO THE STENT AND/OR DELIVERY SYSTEM COMPONENTS. 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 TORTUOUS AND MILDLY CALCIFIED MID LEFT ANTERIOR DESCENDING ARTERY VIA FEMORAL ACCESS, PRE-DILATATION WAS PERFORMED USING A 2.0X12 BALLOON. A 3.0X18 RX XIENCE V STENT DELIVERY SYSTEM WAS ADVANCED, RESISTANCE WAS FELT WITH THE ANATOMY, AND FORCE WAS APPLIED. THE STENT WAS DEPLOYED AT THE TARGET SITE AND A DISTAL EDGE DISSECTION OCCURRED. A 3.0X15 XIENCE V STENT WAS DEPLOYED TO COVER THE DISSECTION. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    174876 XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 2111441

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention