BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2810391 · Received October 31, 2012

    Report

    Report Number
    2024168-2012-06872
    Event Type
    Malfunction
    Date Received
    October 31, 2012
    Date of Event
    October 9, 2012
    Report Date
    October 9, 2012
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION. STENT DISLODGEMENT WAS CONFIRMED. BASED ON VISUAL AND DIMENSIONAL 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 DURING A PROCEDURE TO TREAT A LESION IN THE LEFT ANTERIOR DESCENDING ARTERY WITH HEAVY CALCIFICATION, PRE-DILATATION WAS PERFORMED. A 2.25 X 18 RX XIENCE NANO STENT DELIVERY SYSTEM (SDS) WAS ADVANCED WITHOUT RESISTANCE INTO THE PATIENT ANATOMY AND IT WAS NOTED ON ANGIOGRAPHY THAT THE STENT WAS NO LONGER ON THE BALLOON. REPORTEDLY, THE 2.25 X 18 RX XIENCE NANO SDS AND GUIDING CATHETER WERE REMOVED AS A SINGLE UNIT AND ONCE OUTSIDE OF THE PATIENT ANATOMY IT WAS NOTED THAT THE DISLODGED STENT WAS INSIDE OF THE GUIDING CATHETER. A NEW SAME SIZE RX XIENCE NANO SDS WAS USED TO SUCCESSFULLY TREAT THE TARGET LESION. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 2012641

    Patients

    Seq Age Sex Outcome Treatment
    1