BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 3243751 · Received July 23, 2013

    Report

    Report Number
    2024168-2013-04643
    Event Type
    Malfunction
    Date Received
    July 23, 2013
    Date of Event
    June 28, 2013
    Report Date
    June 28, 2013
    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) 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.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT PRODUCTS: GUIDE WIRE: BMW ELITE,SION BLUE; GUIDE CATH: PROFITJR3.5,ATLASTISPRO. (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE CUSTOMER REPORTED THE DEVICE WAS DISCARDED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT USING AN UNSPECIFIED ARTERY ACCESS APPROACH DURING A PROCEDURE OF THE MILDLY TORTUOUS, MILDLY CALCIFIED, 90% STENOSED, DISTAL RIGHT CORONARY ARTERY (RCA) THE BALANCE MIDDLEWEIGHT (BMW) ELITE GUIDE WIRE WAS ADVANCED TO THE RCA AND A SECOND NON-ABBOTT GUIDE WIRE WAS ADVANCED TO THE ANTERIOR DESCENDING (AV) ARTERY AS A PROTECTIVE WIRE. PRE-DILATATION WAS PERFORMED WITH A NON-ABBOTT BALLOON DILATATION CATHETER (BDC) AT 16 ATMOSPHERES (ATM) FOR 3 TIMES. THE 3.0 X 28 MM XIENCE PRIME STENT DELIVERY SYSTEM (SDS) WAS ADVANCED BUT THE SDS CAUGHT AROUND THE PROXIMAL ANATOMY OF THE RCA AND COULD NOT BE ADVANCED NOR REMOVED. IT WAS NOTED THAT THE BMW ELITE AND THE SECOND GUIDE WIRE WERE NOT AT THIS LOCATION AND WERE NOT ENTANGLED WITH ONE ANOTHER. THE PATIENT WAS MANIPULATED BY INHALING AND PAUSED EXHALE AS THE XIENCE PRIME SDS WAS RELEASED AND EASILY REMOVED FROM THE ANATOMY WITHOUT ISSUE. OUTSIDE THE ANATOMY IT WAS NOTED THAT THE STENT STRUTS WERE FLARED; THE DEVICE WAS NOT USED. INTRAVASCULAR ULTRASOUND (IVUS) EXAMINATION OF THE VESSEL CONFIRMED THAT THE DIAMETER OF THE RCA DISTALLY WAS SMALLER THAN EXPECTED AND THE INNER DIAMETER OF THE VESSEL MEASURED 2.5 MM. A 2.5 X 12 MM AND A 3.0 X 23 MM XIENCE PRIME STENT WERE IMPLANTED WITHOUT ISSUE. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    342567 XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 2121841

    Patients

    Seq Age Sex Outcome Treatment
    1