BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 3170238 · Received June 14, 2013

    Report

    Report Number
    2024168-2013-03720
    Event Type
    Malfunction
    Date Received
    June 14, 2013
    Date of Event
    May 20, 2013
    Report Date
    May 20, 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, SIONBLUE; GUIDE CATH: PROFIT. (B)(4) - RE-INSERTION. THE CUSTOMER REPORTED THE DEVICE WAS DISCARDED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    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 THE PROCEDURE WAS TO TREAT A 90% STENOSED LESION IN THE DISTAL RIGHT CORONARY ARTERY WITH MILD TORTUOSITY AND MODERATE CALCIFICATION. PRE-DILATATION WAS PERFORMED AND THE 2.25 X 18 MM XIENCE PRIME STENT DELIVERY SYSTEM (SDS) WAS ADVANCED, BUT COULD NOT CROSS TO THE LESION DUE TO THE ANATOMY. IT WAS ALSO NOTED THAT THE DISTAL PORTION OF THE STENT OUTER DIAMETER MAY HAVE BEEN TOO LARGE. ADDITIONAL DILATATION WAS PERFORMED AND THE SDS WAS RE-ADVANCED, BUT STILL COULD NOT CROSS TO THE LESION. THE SDS WAS REMOVED AND IT WAS FOUND THAT THE STENT STRUTS WERE FLARED. A NEW 2.25 X 15 MM XIENCE PRIME SDS WAS USED SUCCESSFULLY. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    270722 XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 2102741

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR