BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2912065 · Received January 11, 2013

    Report

    Report Number
    2024168-2013-00264
    Event Type
    Malfunction
    Date Received
    January 11, 2013
    Date of Event
    November 24, 2012
    Report Date
    November 26, 2012
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION. FAILURE TO ADVANCE/CROSS THE LESION COULD NOT BE REPLICATED IN A TESTING ENVIRONMENT AS IT WAS BASED ON OPERATIONAL CIRCUMSTANCES. SHAFT SEPARATION WAS CONFIRMED. 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. REVIEW OF THE COMPLAINT HISTORY OF THE REPORTED LOT DID NOT INDICATE A MANUFACTURING ISSUE. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS BEEN RETURNED FOR INVESTIGATION. THE INVESTIGATION IS NOT COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION. THE ADDITIONAL XIENCE V, REFERENCED IS BEING FILED UNDER A SEPARATE MANUFACTURING REPORT NUMBER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A MILDLY TORTUOUS, NON-CALCIFIED, DE NOVO, 90% STENOSED, MID, LEFT ANTERIOR DESCENDING (LAD) ARTERY STENTING PROCEDURE, AFTER PRE-DILATATION, A XIENCE V 2.5 X 28MM STENT DELIVERY SYSTEM (SDS) WAS ADVANCED, BUT WOULD NOT CROSS THE LESION DUE TO THE PATIENTS ANATOMY. THE XIENCE V 2.5 X 28 MM SDS WAS REMOVED WITHOUT DIFFICULTY AND ANOTHER XIENCE V 2.75 X 23 MM SDS WAS ADVANCED TO THE LESION, BUT ALSO WOULD NOT CROSS DUE TO THE PATIENTS ANATOMY. THE XIENCE V 2.75 X 23MM SDS WAS REMOVED WITHOUT DIFFICULTY AND ANOTHER NON-ABBOTT SDS WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT OR NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE REPORTED. THERE WAS NO ADDITIONAL INFORMATION PROVIDED. QUALITY RECEIVED THE DEVICES WITH THE PROXIMAL SHAFTS SEPARATED. IT WAS CONFIRMED BY THE ACCOUNT THAT THE PROXIMAL SHAFTS SEPARATED DURING ADVANCEMENT AND THERE WAS NO INTERVENTION NEEDED FOR REMOVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    16937 XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 2061441

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR