BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2972467 · Received February 21, 2013

    Report

    Report Number
    2024168-2013-01014
    Event Type
    Malfunction
    Date Received
    February 21, 2013
    Date of Event
    January 27, 2013
    Report Date
    January 28, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, 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. THE ADDITIONAL XIENCE V REFERENCED IS BEING FILED UNDER A SEPARATE MEDWATCH REPORT. EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION. THE SLOW DEFLATION WAS NOT CONFIRMED. BASED ON VISUAL, DIMENSIONAL, AND FUNCTIONAL 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. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT POST STENT DEPLOYMENT, THE STENT DELIVERY SYSTEM (SDS) BALLOONS OF BOTH XIENCE V STENTS WERE SLOW TO DEFLATE. THE 4.0 X 18 MM XIENCE V DEVICE TOOK OVER ONE MINUTE TO COMPLETELY DEFLATE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THERE WAS NO CLINICALLY SIGNIFICANT DELAY OF PROCEDURE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    76704 XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 1012541

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR