BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 4192727 · Received October 22, 2014

    Report

    Report Number
    2024168-2014-06886
    Event Type
    Injury
    Date Received
    October 22, 2014
    Date of Event
    September 29, 2014
    Report Date
    September 29, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P110019
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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. THE REPORTED PATIENT EFFECTS OF DISSECTION AND PERFORATION, AS LISTED IN THE XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM INSTRUCTIONS FOR USE (IFU) ARE KNOWN PATIENT EFFECTS THAT MAY BE ASSOCIATED WITH USE OF A CORONARY STENT IN NATIVE CORONARY ARTERIES. ALTHOUGH 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 DEFICIENCY WITH RESPECT TO MANUFACTURING, DESIGN OR LABELING. THE ADDITIONAL 3.5 X 16 MM GRAFTMASTER AND 4.0 X 16 MM GRAFTMASTER REFERENCED, ARE BEING FILED UNDER SEPARATE MEDWATCH REPORTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED LESION IN THE MID RIGHT CORONARY ARTERY. THE 4.0 X 18 MM XIENCE XPEDITION STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TO THE LESION AND DEPLOYED. AFTER DEPLOYMENT, A DISTAL DISSECTION WAS OBSERVED. TWO NON-ABBOTT STENTS WERE PLACED TO TREAT THE DISSECTION, BUT IT WAS THEN NOTED THAT THE INITIAL DISTAL DISSECTION BECAME A PERFORATION. THE 3.5 X 16 MM GRAFTMASTER STENT WAS DEPLOYED FOR TREATMENT, BUT THE PERFORATION WAS NOT SEALED. THE 4.0 X 16 MM GRAFTMASTER STENT WAS ADVANCED, BUT FAILED TO CROSS DUE TO THE ANATOMY. A 2.8 X 16 MM GRAFTMASTER WAS THEN ADVANCED AND DEPLOYED, AND THE PERFORATION WAS SEALED SUCCESSFULLY. THE PATIENT HAD A GOOD OUTCOME. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    673000 XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 4050241

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention