BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2933440 · Received January 29, 2013

    Report

    Report Number
    2024168-2013-00452
    Event Type
    Injury
    Date Received
    January 29, 2013
    Date of Event
    January 6, 2013
    Report Date
    January 6, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    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.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE COMPLAINT DEVICE WAS RETURNED. FAILURE TO ADVANCE/CROSS THE LESION AND DIFFICULTY/RESISTANCE REMOVING THE DEVICE FROM THE ANATOMY COULD NOT BE REPLICATED IN A TESTING ENVIRONMENT AS THEY WERE BASED ON OPERATIONAL CIRCUMSTANCES. STENT DISLODGEMENT WAS CONFIRMED. BASED ON THE VISUAL AND DIMENSIONAL ANALYSIS OF THE RETURNED DEVICE, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. A REVIEW OF THE COMPLAINT HISTORY OF THE REPORTED LOT DID NOT INDICATE A MANUFACTURING ISSUE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE DISTAL LEFT ANTERIOR DESCENDING ARTERY WITH MILD TORTUOSITY AND MILD CALCIFICATION. PRE-DILATATION WAS PERFORMED AND THE 3.5 X 15 MM XIENCE V STENT DELIVERY SYSTEM (SDS) WAS ADVANCED, BUT COULD NOT CROSS TO THE LESION DUE TO THE ANATOMY, AND THE STENT DISLODGED. SOME RESISTANCE WAS NOTED DURING REMOVAL OF THE SDS. A SNARE DEVICE WAS USED TO REMOVE THE STENT SUCCESSFULLY. A NON-ABBOTT SDS WAS USED TO TREAT THE LESION. THERE WERE NO OTHER DEVICE ISSUES OR PROCEDURE ISSUES NOTED, AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS CASE WAS HAPPENED CHINA JAPAN FRIENDSHIP HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    39005 XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 2050241

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention