BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 3203574 · Received July 3, 2013

    Report

    Report Number
    2024168-2013-04158
    Event Type
    Malfunction
    Date Received
    July 3, 2013
    Date of Event
    May 24, 2013
    Report Date
    June 7, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P110019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION. EVENT, IMPLANT, AND THERAPY DATES: ESTIMATED DATE (REPORTED AS OCCURRING TWO WEEKS PRIOR TO ALERT DATE ON (B)(6) 2013).

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS NOT POSSIBLE TO PERFORM A THOROUGH ANALYSIS ON THE PRODUCT BECAUSE IT WAS NOT RETURNED FOR INVESTIGATION. POTENTIAL CAUSES FOR AIR BEING INTRODUCED INTO THE SYSTEM INCLUDE, BUT ARE NOT LIMITED TO, MATERIAL RUPTURES, LOOSE CONNECTIONS, FAULTY INFLATION DEVICES, FAULTY ACCESSORIES OR TEARS/HOLES IN THE DEVICE. THE LOT HISTORY RECORD (LHR) FOR THIS PRODUCT COULD NOT BE REVIEWED AND A SIMILAR INCIDENT QUERY COULD NOT BE PERFORMED BECAUSE THE PRODUCT WAS NOT RETURNED FOR EVALUATION AND THE PART AND LOT NUMBERS WERE NOT REPORTED. ALTHOUGH THIS DEVICE WAS NOT RETURNED FOR ANALYSIS, THE DEVICES FOR THE OTHER CASES REPORTED IN THIS INCIDENT WERE RETURNED AND THE ISSUE WAS CONFIRMED TO BE DUE TO A POTENTIAL PRODUCT DEFICIENCY WITH THE STOPCOCK. FURTHER ASSESSMENT OF THIS ISSUE PER SITE OPERATING PROCEDURES IS BEING PERFORMED AND APPROPRIATE CORRECTIVE AND PREVENTIVE ACTIONS WILL BE IMPLEMENTED ACCORDINGLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A XIENCE PRIME STENT DELIVERY SYSTEM WAS PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE MANUAL AND ADVANCED TO THE LESION. THE BALLOON WAS INFLATED TO 14 ATMOSPHERES WITH AN INDEFLATOR 30/30 INFLATION DEVICE AND THERE WAS AIR NOTED IN THE DISTAL END OF EACH OF THE BALLOONS. THE DEVICE WAS USED SUCCESSFULLY FOR THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT OR NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE REPORTED. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    304144 XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT

    Patients

    Seq Age Sex Outcome Treatment
    1 INFLATION: INDEFLATOR 30/30