BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIENCE PRIME LL EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 3163138 · Received June 11, 2013

    Report

    Report Number
    2024168-2013-03648
    Event Type
    Malfunction
    Date Received
    June 11, 2013
    Date of Event
    May 8, 2013
    Report Date
    May 18, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P110019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    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 DEVICE WAS RETURNED FOR EVALUATION. THE SHAFT SEPARATION WAS CONFIRMED. THE FAILURE TO ADVANCE/CROSS COULD NOT BE REPLICATED IN A TESTING ENVIRONMENT AS IT WAS BASED ON OPERATIONAL CIRCUMSTANCES. BASED ON VISUAL 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 THE PROCEDURE WAS TO TREAT A TOTALLY OCCLUDED PROXIMAL LEFT ANTERIOR DESCENDING ARTERY. PRE-DILATATION WAS PERFORMED WITH A 1.25 X 15 MM NON-ABBOTT SEMI COMPLIANT BALLOON CATHETER TO 8 ATMOSPHERES AND THEN A NON-ABBOTT 2.5 X 10 MM BALLOON CATHETER TO 10 ATMOSPHERES. AN ATTEMPT WAS MADE TO ADVANCE A 2.5 X 38 MM XIENCE PRIME STENT DELIVERY SYSTEM (SDS); HOWEVER, THE SDS COULD NOT CROSS THE LESION AND THE SHAFT OUTSIDE THE ANATOMY SEPARATED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER STENT DELIVERY SYSTEM. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE AND NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    264421 XIENCE PRIME LL EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 3012941

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR