BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE ALPINE EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 6981454 · Received October 26, 2017

    Report

    Report Number
    2024168-2017-08497
    Event Type
    Injury
    Date Received
    October 26, 2017
    Date of Event
    October 5, 2017
    Report Date
    October 26, 2017
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    UDI-DI
    08717648199103
    PMA / PMN Number
    P110019
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. CONCOMITANT MEDICAL DEVICES: GUIDE WIRE: SION BLUE, GUIDE CATHETER: HYPERION. EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR ANALYSIS. THE REPORTED BEND/KINK WAS ABLE TO BE CONFIRMED. THE REPORTED DIFFICULTY TO REMOVE WAS UNABLE TO BE REPLICATED IN A TESTING ENVIRONMENT AS IT WAS BASED ON OPERATIONAL CIRCUMSTANCES. A REVIEW OF THE LOT HISTORY RECORD IDENTIFIED NO MANUFACTURING NONCONFORMITIES ISSUED TO THE REPORTED LOT THAT WOULD HAVE CONTRIBUTED TO THIS EVENT. ADDITIONALLY, A REVIEW OF THE COMPLAINT HISTORY IDENTIFIED NO OTHER SIMILAR INCIDENTS FROM THIS LOT. THE INVESTIGATION DETERMINED THE REPORTED DIFFICULTIES APPEAR TO BE RELATED TO CIRCUMSTANCES OF THE PROCEDURE AS IT IS LIKELY THAT AS THE SDS WAS REMOVED, RESISTANCE WAS MET WITH THE HEAVILY TORTUOUS, MILDLY CALCIFIED LESION RESULTING IN THE REPORTED DIFFICULTY TO REMOVE. MANIPULATION OF THE DEVICE RESULTED IN THE REPORTED/NOTED BALLOON BEND/INNER MEMBER KINK. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PROCEDURE WAS TO TREAT A HEAVILY TORTUOUS, MILDLY CALCIFIED LESION IN THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE 2.25X28MM XIENCE ALPINE STENT WAS DEPLOYED; HOWEVER, DURING ATTEMPTED REMOVAL RESISTANCE WAS FELT WITH THE ANATOMY AND THE BALLOON BENT. THE STENT DELIVERY SYSTEM (SDS) WAS UNABLE TO BE REMOVED. A 1.2 MM BALLOON DILATATION CATHETER (BDC) WAS INSERTED AND ADVANCED TOWARD THE ALPINE SDS. THE ALPINE SDS WAS ABLE TO BE PULLED PROXIMALLY WITH REACTION FORCE GENERATED BY PUSHING THE BDC FORWARD. THE SDS WAS REMOVED FROM ANATOMY AND THE PROCEDURE WAS COMPLETED. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    759256 XIENCE ALPINE EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 7021541 08717648199103

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention