BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE PRIME LL EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 3191644 · Received June 26, 2013

    Report

    Report Number
    2024168-2013-04010
    Event Type
    Injury
    Date Received
    June 26, 2013
    Date of Event
    June 18, 2013
    Report Date
    June 18, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P110019
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (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. 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 NON-TORTUOUS, MILDLY CALCIFIED, PROXIMAL RIGHT CORONARY ARTERY FOR TREATMENT OF AN 80% STENOSIS, PRE-DILATATION WAS PERFORMED USING A 3.0X15 TREK BALLOON FOLLOWED BY DEPLOYMENT OF A 4.0X33 RX XIENCE PRIME STENT. THE PROXIMAL EDGE OF THE STENT WAS NOT FULLY EXPANDED; THEREFORE, A 4.5X12 VOYAGER NC DILATATION CATHETER WAS ADVANCED BUT COULD NOT CROSS THE PROXIMAL EDGE OF THE STENT AFTER MANY ATTEMPTS. THE DEVICE WAS REPLACED WITH A 4.5X12 NON-ABBOTT DILATATION CATHETER AND POST DILATATION WAS PERFORMED SUCCESSFULLY. THERE WAS NO ADVERSE PATIENT EFFECT AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE DUE TO THE DEVICE(S) ISSUE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290377 XIENCE PRIME LL EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 2102641

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention GUIDE WIRE: RUNTHROUGH