BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIENCE PRIME SV EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 3944821 · Received July 18, 2014

    Report

    Report Number
    2024168-2014-04632
    Event Type
    Malfunction
    Date Received
    July 18, 2014
    Date of Event
    June 24, 2014
    Report Date
    June 25, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P110019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE HEAVILY TORTUOUS AND HEAVILY CALCIFIED, DISTAL RIGHT CORONARY ARTERY. THE 2.25X15 MM XIENCE PRIME STENT DELIVERY SYSTEM (SDS) WAS ADVANCED IN AN ATTEMPT TO CROSS THE LESION; HOWEVER, DID NOT CROSS, RESULTING IN THE PROXIMAL SHAFT BENDING/KINKING. AFTER RETRACTION OF THE DEVICE FROM THE PATIENT AN ATTEMPT WAS MADE TO STRAIGHTEN THE KINK SO THAT THE SDS COULD BE READVANCED; HOWEVER, THIS RESULTED IN A SHAFT SEPARATION 30-40CM DISTAL TO THE HUB. A 2.25X12 MM XIENCE PRIME SDS WAS ADVANCED IN AN ATTEMPT TO CROSS THE LESION; HOWEVER, DID NOT CROSS. THE SDS WAS REMOVED FROM THE PATIENT AND A FLARED STRUT IN THE MIDDLE OF THE STENT IMPLANT WAS OBSERVED. A NON-ABBOTT SDS WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. NO ADVERSE PATIENT EFFECTS OR CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE WERE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    422407 XIENCE PRIME SV EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 2101242

    Patients

    Seq Age Sex Outcome Treatment
    1