BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 3150735 · Received June 6, 2013

    Report

    Report Number
    2024168-2013-03543
    Event Type
    Malfunction
    Date Received
    June 6, 2013
    Date of Event
    May 13, 2013
    Report Date
    May 14, 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). CONCOMITANT PRODUCTS: GUIDE WIRE: RUNTHROUGH HC; GUIDE CATHETER: HEARTRAIL 6F AL1. (B)(4) - AGAINST RESISTANCE. THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). 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 KINK AND SHAFT SEPARATION WERE 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 JAPAN XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM STATES: SHOULD ANY RESISTANCE BE FELT AT ANY TIME DURING EITHER LESION ACCESS OR REMOVAL OF THE DELIVERY SYSTEM POST-STENT IMPLANTATION, REMOVE THE ENTIRE SYSTEM AS A SINGLE UNIT. 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, A 3.5X23 RX XIENCE PRIME STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TOWARD AN ECCENTRIC, MODERATELY CALCIFIED, 99% STENOSED, DE NOVO LESION IN THE MILDLY TORTUOUS DISTAL RIGHT CORONARY ARTERY, HOWEVER, THE SDS FAILED TO CROSS THE LESION DUE TO PATIENT ANATOMY. DURING THE ADVANCEMENT, STRONG RESISTANCE WAS MET AND FORCE WAS APPLIED, RESULTING IN A KINK THEN A SEPARATED SHAFT AT THE KINK SITE, APPROXIMATELY 10 CENTIMETERS FROM THE HUB. AS THE SEPARATION SITE WAS LOCATED OUTSIDE OF PATIENT ANATOMY, THE SDS WAS WITHDRAWN FROM THE ANATOMY WITHOUT RESISTANCE. THE PROCEDURE WAS COMPLETED USING A NON-ABBOTT SDS. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO OCCURRENCE OF A CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    SUBSEQUENT TO THE INITIAL MEDWATCH REPORT, THE TARGET LESION WAS 90% STENOSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    250973 XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 2121341

    Patients

    Seq Age Sex Outcome Treatment
    1