BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 4182078 · Received October 17, 2014

    Report

    Report Number
    2024168-2014-06775
    Event Type
    Malfunction
    Date Received
    October 17, 2014
    Date of Event
    September 23, 2014
    Report Date
    September 23, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR ANALYSIS. THE REPORTED FAILURE TO ADVANCE THE DEVICE AND THE REPORTED DIFFICULTY REMOVING THE DEVICE WERE UNABLE TO BE REPLICATED IN A TESTING ENVIRONMENT AS THEY WERE BASED ON OPERATIONAL CIRCUMSTANCES. THE REPORTED DEVICE DAMAGED BY ANOTHER DEVICE WAS NOT CONFIRMED AS THE DAMAGED DEVICE REMAINS IN THE PATIENT. BASED ON A VISUAL INSPECTION 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 REVIEWED INFORMATION, NO PRODUCT DEFICIENCY WAS IDENTIFIED.

    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 RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A CIRCUMFLEX ARTERY. A 2.25 X 12 MM XIENCE V STENT DELIVERY SYSTEM (SDS) FAILED TO CROSS THROUGH A DEPLOYED 2.75 X 18 MM XIENCE V STENT IMPLANT, AND BECAME ENTANGLED WITH THE DEPLOYED STENT IMPLANT. THE 2.25 X 12 MM XIENCE V SDS WAS REMOVED WITH RESISTANCE NOTED. THE DEPLOYED 2.75 X 18 MM XIENCE V STENT IMPLANT WAS NOTED TO BE DAMAGED. AN UNSPECIFIED BALLOON DILATATION CATHETER (BDC) WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    660977 XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 4041641

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR STENT: 2.75X18MM XIENCE V