BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 4081730 · Received September 11, 2014

    Report

    Report Number
    2024168-2014-05816
    Event Type
    Injury
    Date Received
    September 11, 2014
    Date of Event
    August 28, 2014
    Report Date
    August 28, 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). THERE WAS NO REPORTED DEVICE MALFUNCTION. IT IS INDICATED THAT THE DEVICE IS NOT RETURNING FOR EVALUATION. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. DISSECTION IS LISTED IN THE XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEMS INSTRUCTIONS FOR USE AS A KNOWN PATIENT EFFECT OF CORONARY STENTING PROCEDURES. 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 DURING A PROCEDURE TO TREAT A DE NOVO LESION IN THE DISTAL LEFT ANTERIOR DESCENDING ARTERY WITH HEAVY TORTUOSITY AND HEAVY CALCIFICATION, PRE-DILATATION WAS PERFORMED WITH AN UNSPECIFIED BALLOON CATHETER. A 2.75X18 MM RX XIENCE XPEDITION STENT DELIVERY SYSTEM WAS ADVANCED WITHOUT RESISTANCE AND DEPLOYED; HOWEVER, A DISSECTION OCCURRED. ANOTHER XIENCE XPEDITION STENT WAS IMPLANTED TO TREAT THE DISSECTION. THERE WAS NO ADVERSE PATIENT SEQUELAE AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    560827 XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 403244N

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention