BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 3453580 · Received November 6, 2013

    Report

    Report Number
    2024168-2013-07117
    Event Type
    Injury
    Date Received
    November 6, 2013
    Date of Event
    October 10, 2013
    Report Date
    October 12, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P110019
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THERE WAS NO REPORTED PRODUCT DEFICIENCY. THE REPORTED PATIENT EFFECTS OF ANGINA, MYOCARDIAL INFARCTION, AND THROMBOSIS, AS LISTED IN THE ELECTRONIC XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEMS INSTRUCTIONS FOR USE (IFU), ARE KNOWN PATIENT EFFECTS ASSOCIATED WITH CORONARY STENTING PROCEDURES. 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. THE TREK RX REFERENCED IS BEING FILED UNDER A SEPARATE MANUFACTURING REPORT NUMBERS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROXIMAL LEFT ANTERIOR DESCENDING CORONARY ARTERY STENTING PROCEDURE, DURING LESION PRE-DILATATION WITH A 3.5X08MM RX TREK BALLOON DILATATION CATHETER, THE BALLOON KEPT WATERMELON SEEDING OUT OF THE LESION. AT THAT POINT, IT WAS DECIDED TO USE A NON-ABBOTT CUTTING BALLOON, RESULTING IN A MINOR DISSECTION WITHIN THE LESION. A 3.5X15MM XIENCE XPEDITION WAS IMPLANTED IN THE LESION, RESOLVING THE DISSECTION. POST PROCEDURE, THE PATIENT EXPERIENCED UNSTABLE ANGINA, SIGNIFICANTLY ELEVATED CARDIAC ENZYMES AND THE ELECTROCARDIOGRAM WAS POSITIVE FOR A MYOCARDIAL INFARCTION. ONE DAY POST-PROCEDURE, THE PATIENT WAS TAKEN BACK TO THE CATHETER LAB FOR A DIAGNOSTIC PROCEDURE. THROMBOSIS WAS FOUND IN THE OSTIUM OF THE VESSEL AND PROXIMAL TO THE STENT. THE THROMBOSIS WAS TREATED WITH THROMBECTOMY AND PLACEMENT OF A NON-ABBOTT STENT. ADDITIONALLY, A BALLOON PUMP WAS INSERTED FOR ABOUT 24 HOURS. FIVE DAYS POST-PROCEDURE, THE PATIENT WAS TRANSFERRED FROM THE INTENSIVE CARE UNIT TO A STEP DOWN UNIT. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    571492 XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 3053041

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization| R| S FLEXTONE CUTTING BALLOON