BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2048850 · Received April 11, 2011

    Report

    Report Number
    2024168-2011-02525
    Event Type
    Injury
    Date Received
    April 11, 2011
    Date of Event
    October 24, 2010
    Report Date
    January 11, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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. CONCOMITANT MEDICAL PRODUCTS: STENT: XIENCE V: 2.5 X 12 MM ( 1009539-12/8091261); 3.5 X 18 MM (1009542-18/8082061); 3.5 X 12 MM (1009542-12/8060261); OTHER: ASPIRIN, CLOPIDOGREL. THERE WAS NO REPORTED PRODUCT DEFICIENCY. ANGINA, VENTRICULAR TACHYCARDIA, MYOCARDIAL INFARCTION (MI), AND RESTENOSIS ARE KNOWN ADVERSE EVENTS AS LISTED IN THE XIENCE V INSTRUCTIONS FOR USE (IFU). IT WAS REPORTED THAT THE STENT DELIVERY SYSTEM (SDS) WAS DELIVERED WITHOUT PRE-DILATATION (DIRECT STENTING). IMPLANTING THE STENT WITHOUT PRE-DILATATION LIKELY DID NOT CONTRIBUTE TO THE REPORTED PATIENT EFFECTS APPROXIMATELY 23 MONTHS POST-PROCEDURE. HOWEVER, IT SHOULD BE NOTED THAT THE IFU STATES THAT THE VESSEL SHOULD BE PRE-DILATED WITH AN APPROPRIATE SIZED BALLOON. FAILURE TO DO SO MAY INCREASE THE DIFFICULTY OF STENT PLACEMENT AND CAUSE PROCEDURAL COMPLICATIONS. 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 OR DESIGN.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA A TRIAL THAT ON (B)(6) 2008, THE PATIENT UNDERWENT DIRECT STENTING IN THE DISTAL RIGHT CORONARY ARTERY (DRCA) WITH ONE 3.0 X 15 MM XIENCE V STENT, IN THE PRE-DILATED RIGHT POSTERIOR DESCENDING ARTERY WITH ONE 2.5 X 12 MM XIENCE V STENT, AND IN THE PRE-DILATED PROXIMAL LEFT CIRCUMFLEX ARTERY (LCX) WITH ONE 3.5 X 18 MM AND ONE 3.5 X 12 MM XIENCE V STENT. ON (B)(6) 2010, THE PATIENT WAS RE-ADMITTED FOR A NON ST MYOCARDIAL INFARCTION WITH CHEST PAIN AND WAS FOUND TO HAVE 17 BEATS OF VENTRICULAR TACHYCARDIA. AN ANGIOGRAM DONE ON (B)(6) 2010 REVEALED 100% IN-STENT RESTENOSIS IN THE DRCA, 99% STENOSIS IN THE DISTAL LCX, AND 95% STENOSIS IN THE NON-TARGET LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE PROXIMAL LCX STENT WAS PATENT AND ONLY THE NON-TARGET LAD LESION WAS TREATED WITH A NEW XIENCE V STENT. THE PATIENT WAS NOT A SURGICAL CANDIDATE FOR CORONARY BYPASS SURGERY, BUT THE EVENT WAS CONSIDERED RESOLVED ON (B)(6) 2010 UPON DISCHARGE. ALTHOUGH NO CORONARY INTERVENTION WAS PERFORMED IN THE OTHER TWO VESSELS, THE PATIENT WAS STARTED ON NEW MEDICATIONS (COREG AND LISINOPRIL). THE PHYSICIAN INDICATED THAT THE LAD LESION WAS THE PROBABLE CULPRIT LESION FOR THE MI. THE ABBOTT CLINICAL EVENTS COMMITTEE (CEC) DETERMINED THAT THE Q-WAVE MI WAS NOT CAUSED BY THE TARGET VESSEL. THE CEC ALSO DETERMINED THAT THE RCA INDEX LESION WAS IN THE MID SEGMENT OF THE VESSEL, NOT THE DISTAL SEGMENT. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    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 8071861

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Hospitalization| O| S