BEUDAMED
    FDA Adverse Event Death Summary report: N

    XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 3081146 · Received April 26, 2013

    Report

    Report Number
    2024168-2013-02616
    Event Type
    Death
    Date Received
    April 26, 2013
    Date of Event
    April 8, 2013
    Report Date
    April 11, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P110019
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    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. (B)(4). THERE WAS NO REPORTED PRODUCT DEFICIENCY AND THE PRODUCT WAS NOT RETURNED. THE REPORTED PATIENT EFFECTS OF DEATH AND PERFORATION ARE LISTED IN THE XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEMS INSTRUCTIONS FOR USE (IFU) AS KNOWN ADVERSE EVENTS. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS AND THE RELATIONSHIP TO THE DEVICE, IF ANY, CANNOT BE DETERMINED, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURE, DESIGN, OR LABELING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ELECTIVE PROCEDURE OF THE MODERATELY CALCIFIED, 80% STENOSED, PROXIMAL AND DISTAL LEFT ANTERIOR DESCENDING (LAD) ARTERY, USING A FEMORAL ARTERY ACCESS APPROACH, THE 3.5 X 15 MM RX XIENCE XPEDITION STENT WAS DEPLOYED IN THE PROXIMAL LESION AND A 3.5 X 8 MM RX XIENCE XPEDITION STENT WAS DEPLOYED MORE DISTAL WITHOUT ISSUE. THE STENT DELIVERY SYSTEM (SDS) BALLOON WAS USED TO POST-DILATE THE JUNCTION BETWEEN THE TWO STENTS. CONTRAST WAS INJECTED FOR ANGIOGRAPHY AND A PERFORATION WAS NOTED. A 4.0 X 12 MM NON-ABBOTT BALLOON WAS INFLATED AT THE PERFORATION LOCATION. APPROXIMATELY 700 ML OF BLOOD WAS REMOVED FROM THE PERICARDIAL SAC; ADDITIONAL SURGICAL PERSONNEL OPENED THE CHEST FOR INTERVENTION, HOWEVER, THE PATIENT CONDITION DETERIORATED. THE PATIENT DIED IN THE CATH LAB DURING THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    181182 XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Death 3.5 X 15 MM RX XIENCE XPEDITION STENT