BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2962448 · Received February 14, 2013

    Report

    Report Number
    2024168-2013-00878
    Event Type
    Malfunction
    Date Received
    February 14, 2013
    Date of Event
    January 5, 2013
    Report Date
    January 7, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P110019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    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. THE RESISTANCE BETWEEN THE SDS AND GUIDE WIRE WAS NOT CONFIRMED. HOWEVER, IT WAS NOTED THAT THE STENT IMPLANT WAS DISLODGED AND NOT RETURNED. IT COULD NOT BE CONFIRMED WHEN THE STENT DISLODGED FROM THE BALLOON; HOWEVER, IT WAS CONFIRMED THAT THE STENT IMPLANT WAS NOT IN THE PATIENT ANATOMY. BASED ON VISUAL, FUNCTIONAL, AND DIMENSIONAL 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. THE RESULTS OF THE QUERY OF SIMILAR INCIDENTS IN THE COMPLAINT HANDLING DATABASE FOR THIS 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 FRICTION WAS FELT BETWEEN THE 2.5 X 18 MM XIENCE PRIME STENT DELIVERY SYSTEM (SDS) AND THE NON-ABBOTT GUIDE WIRE DURING ADVANCEMENT OF THE SDS TO THE LESION; HOWEVER, THE STENT WAS ABLE TO BE DEPLOYED SUCCESSFULLY. NO RESISTANCE WAS FELT DURING RETRACTION OF THE SDS FROM THE ANATOMY. THERE WAS NO ADVERSE PATIENT EFFECTS OR CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE REPORTED. RETURN DEVICE ANALYSIS REVEALED THE BALLOON WAS TIGHTLY FOLDED AND IT DID NOT APPEAR THAT THE STENT IMPLANT HAD BEEN DEPLOYED, RATHER THAT THE STENT IMPLANT HAD DISLODGED FROM THE BALLOON. IT IS UNKNOWN WHEN THE STENT DISLODGED; HOWEVER, IT WAS CONFIRMED WITH THE ACCOUNT THAT THE STENT IMPLANT IS NOT IN THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    64912 XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 2082841

    Patients

    Seq Age Sex Outcome Treatment
    1 GUIDE WIRE: RUNTHROUGH