BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 3061940 · Received April 16, 2013

    Report

    Report Number
    2024168-2013-02331
    Event Type
    Injury
    Date Received
    April 16, 2013
    Date of Event
    March 22, 2013
    Report Date
    March 22, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P110019
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THERE WAS NO REPORTED PRODUCT DEFICIENCY AND THE PRODUCT WAS NOT RETURNED. THE REPORTED PATIENT EFFECTS OF ANGINA AND THROMBOSIS, AS LISTED IN THE INSTRUCTIONS FOR USE, ARE KNOWN ADVERSE EVENTS 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.

    Additional Manufacturer Narrative · 1

    (B)(4). THE ADDITIONAL XIENCE XPEDITION STENT MENTIONED WILL BE FILED UNDER A SEPARATE MEDWATCH REPORT NUMBER. THE DEVICE REMAINS IN THE PATIENT. THE INVESTIGATION IS NOT YET COMPLETE. A FOLLOW UP WILL BE FILED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    SUBSEQUENT TO THE INITIAL MEDWATCH REPORT FILING, IT WAS NOTED THAT THE SIZE OF THE IMPLANTED XIENCE XPEDITION STENTS WERE 3.0 X 12 MM, NOT 2.5 X 08 MM.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE HOSPITAL WITH ANGINA. THE TARGET LESION WAS LOCATED IN THE DISTAL CIRCUMFLEX ARTERY (CX). PRE-DILATATION WAS PERFORMED WITH A 2.5 X 06 MM UNSPECIFIED CUTTING BALLOON. THEN, TWO 2.5 X 08 MM XIENCE XPEDITION STENTS WERE IMPLANTED AND POST DILATATION WAS PERFORMED. ANGIOMAX, ASPIRIN AND 60 MG OF EFFIENT WERE GIVEN DURING STENT PLACEMENT. DESPITE STENT DEPLOYMENT, THE PATIENT WAS STILL EXPERIENCING ANGINA WHILE BEING TRANSFERRED OUT OF THE CATH LAB. THE PATIENT WAS BROUGHT BACK INTO THE CATH LAB AND ANGIOGRAPHY REVEALED THROMBOSIS IN THE STENTED CX. BALLOONING AND THROMBECTOMY WERE PERFORMED AND HEPARIN WAS GIVEN. THE PHYSICIAN STATED THAT THE THROMBOSIS WAS NOT DUE TO THE STENTS, BECAUSE THE PATIENT APPEARED TO HAVE A CLOT ISSUE, AS DESPITE BEING GIVEN A FULL BOLUS OF INTEGRILIN, CLOTTING WAS STILL NOTED. THE PATIENT WAS REPORTED TO BE STABLE. NO ADVERSE PATIENT SEQUELA WAS REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    162950 XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 2110541

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention STENT: XIENCE XPEDITION 2.5 X 08 MM| STENT: 3.0 X 12 MM XIENCE XPEDITION