BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2006624 · Received March 3, 2011

    Report

    Report Number
    2024168-2011-01357
    Event Type
    Injury
    Date Received
    March 3, 2011
    Date of Event
    September 24, 2010
    Report Date
    November 1, 2010
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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: 1009539-28/8071761; 1009539-15/8060961; 1009541-15/8061061. THE STENT REMAINS IN THE PATIENT. THERE WAS NO REPORTED PRODUCT DEFICIENCY. ANGINA, HYPERTENSION, AND MI ARE KNOWN AS ADVERSE EVENTS OF CORONARY STENTING AS LISTED IN THE XIENCE V INSTRUCTIONS FOR USE. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS AND THE RELATIONSHIP, IF ANY, TO THE XIENCE V DEVICE 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 STENTING IN THE PRE-DILATED LEFT MID FIRST DIAGONAL ARTERY WITH TWO 2.5 X 28 MM XIENCE V STENTS AND IN THE PREDILATED LEFT DISTAL CIRCUMFLEX ARTERY WITH TWO (2.5 X 15 MM AND 3.0 X 15 MM) XIENCE V STENTS. ON (B)(6) 2010, THE PATIENT EXPERIENCED CHEST PAIN AND HYPERTENSION. THE PATIENT WAS RE-ADMITTED ON (B)(6) 2010 FOR OBSERVATION AND BLOOD PRESSURE CONTROL. TWO NEW MEDICATIONS WERE STARTED FOR BLOOD PRESSURE, AMLODIPINE AND HYDRALAZINE. THE EVENT RESOLVED ON (B)(6) 2010 UPON DISCHARGE. ON (B)(6) 2010, THE PATIENT EXPERIENCED CHEST PAIN AGAIN THAT WAS RELIEVED WITH TWO TABLETS OF SUBLINGUAL NITROGLYCERIN. THE PATIENT WAS RE-ADMITTED OVERNIGHT AND HAD A NUCLEAR STRESS TEST WITH NO EVIDENCE OF ISCHEMIA. ON (B)(6) 2010, THE EVENT RESOLVED AND THE PATIENT WAS DISCHARGED HOME. BOTH OF THESE ANGINA EVENTS WERE ADJUDICATED BY THE CLINICAL EVENTS COMMITTEE AS NON Q WAVE MYOCARDIAL INFARCTIONS (MI). THE LATTER MI WAS THOUGHT BY THE ADJUDICATOR TO BE A SMALL MI THAT MAY HAVE BEEN A RESIDUAL OF THE FORMER MI. 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 8050841

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization| R| S