BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2843023 · Received November 21, 2012

    Report

    Report Number
    2024168-2012-07400
    Event Type
    Injury
    Date Received
    November 21, 2012
    Date of Event
    October 30, 2012
    Report Date
    October 30, 2012
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, 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. THERE WAS NO REPORTED PRODUCT DEFICIENCY. THE REPORTED PATIENT EFFECTS OF ANGINA AND THROMBOSIS ARE KNOWN OBSERVED AND POTENTIAL ADVERSE EVENTS AS LISTED IN THE XIENCE V EVERLOIMUS ELUTING CORONARY STENT SYSTEM INSTRUCTIONS FOR USE (IFU). 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 XIENCE IS BEING FILED UNDER A SEPARATE MANUFACTURING REPORT NUMBER.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A PATIENT THAT HAD BEEN HAVING CHEST PAIN FOR 2-3 DAYS. ON (B)(6) 2012, THE PATIENT HAD A 2.25 X 18 MM XIENCE V AND A 2.5 X 18 MM XIENCE V STENTS IMPLANTED IN A HEAVILY CALCIFIED RIGHT CORONARY ARTERY. DURING THAT PROCEDURE, A ROTOBLADER WAS USED BEFORE IMPLANTING THE STENTS. SEVERAL NON-COMPLIANT BALLOONS WERE USED FOR POST DILATATION; HOWEVER, THE PHYSICIAN COMMENTED THAT THE OVERLAPPING SEGMENT OF THE TWO STENTS APPEARED TO BE UNDER EXPANDED. THE PATIENT HAD CHEST PAIN FOR 2-3 DAYS AND A DIAGNOSTIC CATHETER WAS ADVANCED AND IT SHOWED THERE WAS NO FLOW DISTAL TO THE IMPLANTED STENTS AS THE STENTS WERE CLOSED WITH THROMBUS. ALTHOUGH THERE WAS NO FLOW DISTAL, THERE WAS COLLATERAL FLOW FROM THE LEFT TO RIGHT CORONARY ARTERIES, SO THERE WAS NO TREATMENT PERFORMED.

    Description of Event or Problem · 1

    SUBSEQUENT TO FILING THE INITIAL MEDWATCH REPORT ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE REPORTED UNDER EXPANSION OF THE OVERLAPPED STENTS WAS DUE TO CALCIUM IN THE LESION. THERE WERE NO DEPLOYMENT ISSUES DURING THE ORIGINAL PROCEDURE. THE PATIENT WAS DISCHARGED AND RETURNED TO THE HOSPITAL WITH CHEST PAIN ON (B)(6) 2012, FOR THE DIAGNOSTIC PROCEDURE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Hospitalization| O STENT: 2.25 X 18 MM XIENCE V