BEUDAMED
    FDA Adverse Event Death Summary report: N

    XIENCE XPEDITION 48 EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 8241388 · Received January 11, 2019

    Report

    Report Number
    2024168-2019-00303
    Event Type
    Death
    Date Received
    January 11, 2019
    Date of Event
    December 10, 2018
    Report Date
    March 14, 2019
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P110019
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    INTERNAL FILE NUMBER: (B)(4). LOT NUMBER CHANGED FROM 8020941 TO 8050141. THE DEVICE WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE LOT HISTORY RECORD IDENTIFIED NO MANUFACTURING NONCONFORMITIES ISSUED TO THE REPORTED LOT THAT WOULD HAVE CONTRIBUTED TO THIS EVENT. THE REPORTED PATIENT EFFECTS OF DEATH AND THROMBOSIS ARE LISTED AS FORESEEABLE EVENTS. A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING.

    Description of Event or Problem · 0

    SUBSEQUENT TO THE PREVIOUSLY FILED MEDWATCH REPORT, THROMBUS WAS OBSERVED IN THE STENT. THE PATIENT'S HEALTH WAS DECLINING PRIOR TO DEVICE USE. IT WAS CONFIRMED THAT THE LOCATION OF THE LESION WAS THE OBTUSE MARGINAL. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE STENT REMAINS IN THE PATIENT. INVESTIGATION IS NOT YET 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 LESION LOCATED IN THE MID-CORONARY MARGINAL ARTERY THAT WAS MILDLY CALCIFIED, MILDLY TORTUOUS AND 90% STENOSED. PRIOR TO THIS PROCEDURE, THE PATIENT PRESENTED WITH CARDIAC ARREST. THE LESION WAS PRE-DILATED WITH AN NC BALLOON DILATATION CATHETER. THE XIENCE XPEDITION 2.75 X 48 MM STENT WAS SUCCESSFULLY DEPLOYED AND THE PATIENT WAS MOVED TO THE WARD. HOWEVER, AFTER SOME TIME, THE PATIENT DIED IN THE WARD THE SAME DAY DUE TO CARDIAC ARREST. IN THE PHYSICIAN'S OPINION THE XIENCE "XPEDIDTION" DID NOT CAUSE OR CONTRIBUTE TO THE DEATH, HOWEVER, THROMBUS WAS OBSERVED. THERE WAS NO ISSUE WITH THE DEVICE, PATIENT HEALTH WAS DECLINING PRIOR TO DEVICE USE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    32094 XIENCE XPEDITION 48 EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 8050141

    Patients

    Seq Age Sex Outcome Treatment
    1 Death