BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 3140576 · Received May 31, 2013

    Report

    Report Number
    2024168-2013-03418
    Event Type
    Malfunction
    Date Received
    May 31, 2013
    Date of Event
    April 30, 2013
    Report Date
    May 7, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION. STENT DISLODGMENT WAS CONFIRMED. BASED ON VISUAL ANALYSIS, 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. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT USING A LEFT FEMORAL ARTERY ACCESS APPROACH DURING A HIGHLY CALCIFIED, CIRCUMFLEX ARTERY THE XIENCE V STENT DELIVERY SYSTEM (SDS) WAS USED WITH A 6 FR GUIDE LINER CATHETER AND DURING ADVANCING WITHOUT RESISTANCE NOTED, THE STENT BECAME DISLODGED ONTO THE PROXIMAL SHAFT. THE DEVICE WAS REMOVED FROM THE ANATOMY 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
    240943 XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 2030741

    Patients

    Seq Age Sex Outcome Treatment
    1 GUIDE CATH: 6 FR GUIDE LINER