BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 3130811 · Received May 24, 2013

    Report

    Report Number
    2024168-2013-03298
    Event Type
    Injury
    Date Received
    May 24, 2013
    Date of Event
    November 11, 2012
    Report Date
    May 2, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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. DATE OF EVENT ESTIMATED AS (B)(6) 2012. DATE OF IMPLANT ESTIMATED AS (B)(6) 2003. (B)(4) - INDICATION FOR USE. THERE WERE NO REPORTED PRODUCT DEFICIENCIES. THE REPORTED PATIENT EFFECTS OF MYOCARDIAL INFARCTION AND STENOSIS/RESTENOSIS ARE LISTED IN THE XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM INSTRUCTIONS FOR USE (IFU) AS KNOWN ADVERSE EVENTS OF CORONARY STENTING PROCEDURES. IT SHOULD BE NOTED THAT THE IFU STATES: XIENCE V IS INDICATED FOR IMPROVING CORONARY LUMINAL DIAMETER IN PATIENTS WITH SYMPTOMATIC HEART DISEASE DUE TO DE NOVO (NEW) NATIVE CORONARY ARTERY LESIONS. 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. ARTICLE: THREE-YEAR FOLLOW-UP AFTER TREATMENT OF BARE-METAL STENT RESTENOSIS WITH FIRST-GENERATION OR SECOND-GENERATION DRUG-ELUTING STENTS.

    Description of Event or Problem · 1

    THIS EVENT WAS CAPTURED BASED ON REVIEW OF THE ARTICLE: THREE-YEAR FOLLOW-UP AFTER TREATMENT OF BARE-METAL STENT RESTENOSIS WITH FIRST-GENERATION OR SECOND-GENERATION DRUG-ELUTING STENTS. IT WAS REPORTED THAT THIS SINGLE CENTER STUDY WHICH RAN FROM JUNE 2003 TO JUNE 2009 CONSISTED OF 264 CONSECUTIVE PATIENTS WITH BARE METAL STENT IN-STENT RESTENOSIS WITH IMPLANTATION OF 75 OF THE PATIENTS WITH XIENCE V STENTS. CLINICAL OUTCOMES WERE AS FOLLOWS: 27% MAJOR ADVERSE CARDIOVASCULAR EVENT (INCLUDING DEATH, MYOCARDIAL INFARCTION, AND TARGET LESION REVASCULARIZATION); 16% TARGET VESSEL REVASCULARIZATION. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    231382 XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R| S