BEUDAMED
    FDA Adverse Event Death Summary report: N

    XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 3757972 · Received April 17, 2014

    Report

    Report Number
    2024168-2014-02438
    Event Type
    Death
    Date Received
    April 17, 2014
    Date of Event
    March 26, 2014
    Report Date
    March 26, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P110019
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    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. THE STENT REMAINS IN THE PATIENT. IT IS INDICATED THAT THE DEVICE IS NOT RETURNING FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. A SIMILAR INCIDENT QUERY IN THE COMPLAINT HANDLING DATABASE FOR THIS LOT WAS NOT PERFORMED AS THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. ADDITIONALLY, THE REPORTED PATIENT EFFECTS OF DEATH, HYPERSENSITIVITY, VENTRICULAR TACHYCARDIA, AND VASOCONSTRICTION, AS LISTED IN THE XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM INSTRUCTIONS FOR USE (IFU) ARE KNOWN PATIENT ADVERSE EFFECTS THAT MAY BE ASSOCIATED WITH USE OF A CORONARY STENT IN NATIVE CORONARY ARTERIES. BASED ON THE INFORMATION REVIEWED, THERE IS NO EVIDENCE TO INDICATE THE PRESENCE OF A PRODUCT DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT POST STENTING PROCEDURE USING A FEMORAL ARTERY ACCESS APPROACH FOR THE PROCEDURE OF THE MODERATELY CALCIFIED, MILDLY TORTOUS, 80% STENOSED, DE NOVO, MID RIGHT CORONARY ARTERY (RCA) SUCCESSFUL PREDILATATION WITH A SEMI-COMPLIANT UNSPECIFIED BALLOON CATHETER, AND POST-DILATATION WITH A REGULAR NON-COMPLIANT UNSPECIFIED BALLOON CATHETER WAS PERFORMED. THE 2.75 X 23 MM XIENCE XPEDITION STENT WAS IMPLANTED WITHOUT REPORTED ISSUE. IT WAS NOTED THAT SHORTLY AFTER THE STENTING THE PATIENT HAD SUDDEN SEVERE SPASM FOLLOWED BY VENTRICULAR TACHYCARDIA AND DIED IN THE CATH LAB SUITE. THE PHYSICIAN SUSPECTED THAT IT MAY HAVE BEEN AN ALLERGIC REACTION/HYPERSENSITIVITY WITH THE STENT DRUG OR STENT POLYMER. THE SPECIFIC CAUSE OF DEATH WAS NOT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    235748 XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 3062541

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Death