BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE XPEDITION 48 EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 6203431 · Received December 23, 2016

    Report

    Report Number
    2024168-2016-09271
    Event Type
    Injury
    Date Received
    December 23, 2016
    Date of Event
    December 9, 2016
    Report Date
    December 23, 2016
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    UDI-DI
    08717648158643
    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 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. A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECT, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED. THE REPORTED PATIENT EFFECT OF DISSECTION IS LISTED IN THE XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM ELECTRONIC INSTRUCTIONS FOR USE AS A KNOWN PATIENT EFFECT OF CORONARY STENTING PROCEDURES. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO THE DESIGN, MANUFACTURE, OR LABELING OF THE DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE MID LEFT ANTERIOR DESCENDING ARTERY WITH MILD TORTUOSITY. A 2.5 X 48 MM XIENCE XPEDITION RX STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TOWARD THE TARGET LESION, THE SYSTEM WAS INFLATED TO NOMINAL PRESSURE AND THE STENT WAS IMPLANTED. AN EDGE DISSECTION WAS NOTED. A 3.0 X 15 MM XIENCE PRIME STENT WAS USED TO COVER THE DISSECTION. THERE WAS NO ADVERSE PATIENT SEQUELA. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    852340 XIENCE XPEDITION 48 EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 6053041 08717648158643

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention