BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2853386 · Received November 30, 2012

    Report

    Report Number
    2024168-2012-07599
    Event Type
    Injury
    Date Received
    November 30, 2012
    Date of Event
    October 18, 2012
    Report Date
    October 21, 2012
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JO
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION. 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. THE REPORTED PATIENT EFFECT THROMBOSIS, AS LISTED IN THE XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM INSTRUCTIONS FOR USE, IS A KNOWN ADVERSE EVENT ASSOCIATED WITH CORONARY STENTING PROCEDURES. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE DEVICE HAS BEEN RETURNED FOR INVESTIGATION. THE INVESTIGATION IS NOT COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MILDLY TORTUOUS, MILDLY CALCIFIED, AND 80% STENOSED PROXIMAL RIGHT ATRIUM ARTERY. PRE-DILATATION WAS SUCCESSFULLY PERFORMED WITH AN RX TREK A 3.5 X 18 MM XIENCE V STENT DELIVERY SYSTEM (SDS) WAS BEING ADVANCED OVER A HT PILOT GUIDE WIRE; HOWEVER, THE SDS COULD NOT CROSS THE LESION DUE TO A SHARP CURVE AND THE CALCIFIED LESION. THE PROCEDURE WAS ENDED AT THIS POINT DUE TO SUSPECTED THROMBOSIS. THE PHYSICIAN DECIDED TO GIVE THE PATIENT AGGRASTAT (TIROFIBAN HCL) FOR TWO DAYS AND THE PATIENT WAS THEN SUCCESSFULLY TREATED WITH A 3.0 X 23 MM XIENCE V STENT DELIVERY SYSTEM IN THE RIGHT CORONAY ARTERY. THE LEFT CIRCUMFLEX WAS ALSO SUCCESSFULLY TREATED TWO DAYS LATER WITH A 2.75 X 33 MM AND 3.0 X 15 MM XIENCE STENTS. THERE WAS A CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 2060741

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention GUIDE WIRE: HT PILOT