BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 3974067 · Received August 1, 2014

    Report

    Report Number
    2024168-2014-04927
    Event Type
    Injury
    Date Received
    August 1, 2014
    Date of Event
    January 15, 2014
    Report Date
    July 15, 2014
    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). THE RX XIENCE V 2.75X28MM AND 3.0X15MM MENTIONED ARE BEING FILED UNDER SEPARATE MANUFACTURER REPORT NUMBERS. CONCOMITANT PRODUCTS: STENT: XIENCE V 3.0X15MM; 2.75X28MM; 3.0X28MM. XIENCE PRIME 3.0X38MM. THERE WAS NO REPORTED DEVICE MALFUNCTION AND THE PRODUCT WAS NOT RETURNED. THE REPORTED PATIENT EFFECTS OF ANGINA, ATRIAL FIBRILLATION, RESTENOSIS, AS LISTED IN THE XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM INSTRUCTIONS FOR USE (IFU) ARE KNOWN PATIENT EFFECTS THAT MAY BE ASSOCIATED WITH THE USE OF CORONARY STENTS. 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.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2012, A 3.5X28MM, 3.0X15MM, AND A 2.75X28MM XIENCE V STENTS WERE SUCCESSFULLY IMPLANTED IN THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD) TO THE LEFT MAIN (LM), AND THE PROXIMAL AND THE DISTAL LEFT CIRCUMFLEX (CX) CORONARY ARTERIES, RESPECTIVELY. ON (B)(6) 2012, A 3.0X28MM XIENCE V STENT WAS SUCCESSFULLY IMPLANTED IN THE PROXIMAL RIGHT CORONARY ARTERY (RCA) AND A 3.0X38MM XIENCE PRIME STENT WAS SUCCESSFULLY IMPLANTED IN THE MID RCA. THE PATIENT WAS DISCHARGED HOME THE FOLLOWING DAY. ON (B)(6) 2014 THE PATIENT STARTED EXPERIENCING ANGINA. THE PATIENT WAS HOSPITALIZED AND MEDICATION WAS ADMINISTERED. AN ECHOCARDIOGRAM WAS PERFORMED, AND IN-STENT RE-STENOSIS WAS OBSERVED IN THE LAD AND CX. THERE WAS NO RE-STENOSIS IN THE RCA. ON (B)(6) 2014, THE PATIENT WENT FOR A CORONARY ARTERY BYPASS SURGERY OF THE LAD, THE OBTUSE MARGINAL AND THE DIAGONAL CORONARY ARTERIES. THE PATIENT ALSO EXPERIENCED ATRIAL FIBRILLATION AND MEDICATION WAS ADMINISTERED AS TREATMENT DURING THIS HOSPITALIZATION THAT RESOLVED WITHOUT SEQUELA. ON (B)(6) 2014, THE CHEST PAIN RESOLVED WITHOUT SEQUELA. ON (B)(6) 2014, THE PATIENT WAS NOTED TO HAVE CONGESTIVE HEART FAILURE (CHF). AN ECHOCARDIOGRAM WAS PERFORMED AND MEDICATION WAS GIVEN. THERE WAS NO REPORTED HOSPITALIZATION AND THE CHF RESOLVED WITHOUT SEQUELA ON (B)(6) 2014. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Description of Event or Problem · 1

    SUBSEQUENT TO THE INITIAL MEDWATCH REPORT, THE FOLLOWING INFORMATION WAS RECEIVED: THE PATIENT WAS HOSPITALIZED FOR THE CONGESTIVE HEART FAILURE (CHF) OCCURRING ON (B)(6) 2014 AND A CHEST COMPUTED TOMOGRAPHY (CT) WAS PERFORMED. BOTH THE CHF AND ATRIAL FIBRILLATION HAVE NOW BEEN DEEMED NOT RELATED TO THE DEVICE AND NOT RELATED TO THE PROCEDURE. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    450879 XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 2010441

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Hospitalization| R| S