BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2990249 · Received March 5, 2013

    Report

    Report Number
    2024168-2013-01279
    Event Type
    Injury
    Date Received
    March 5, 2013
    Date of Event
    January 1, 2013
    Report Date
    February 19, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    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. PATIENT AGE ESTIMATED AS (B)(6). PATIENT GENDER ESTIMATED AS MALE. DATE OF EVENT ESTIMATED AS DATE OF PUBLICATION, (B)(6) 2013. DATE OF IMPLANT ESTIMATED AS (B)(6) 2009. THERE WAS NO REPORTED PRODUCT DEFICIENCY AND THE PRODUCT WAS NOT RETURNED. THE REPORTED PATIENT EFFECTS OF CEREBROVASCULAR ACCIDENT (STROKE), TRANSIENT ISCHEMIC ATTACK (STROKE), MYOCARDIAL INFARCTION, THROMBOSIS, AND RESTENOSIS, AS LISTED IN THE XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM INSTRUCTIONS FOR USE, ARE KNOWN ADVERSE EVENTS ASSOCIATED WITH CORONARY STENTING PROCEDURES. 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, IMPACT OF ATRIAL FIBRILLATION ON CLINICAL OUTCOMES AMONG PATIENTS WITH CORONARY ARTERY DISEASE UNDERGOING REVASCULARISATION WITH DRUG-ELUTING STENTS. THE PROMUS REFERENCED IS BEING FILED UNDER A SEPARATE MEDWATCH REPORT. THE ADDITIONAL ADVERSE PATIENT EFFECT OF DEATH REFERENCED ARE BEING FILED UNDER A SEPARATE MEDWATCH REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THIS EVENT WAS CAPTURED BASED ON LITERATURE REVIEW. THE OBJECTIVE OF THIS STUDY WAS TO INVESTIGATE THE IMPACT OF ATRIAL FIBRILLATION (AF) ON LONG-TERM CLINICAL OUTCOMES IN PATIENTS WITH CORONARY ARTERY DISEASE (CAD) UNDERGOING PERCUTANEOUS CORONARY INTERVENTION (PCI) WITH DRUG-ELUTING STENTS (DES). AMONG 6,308 CONSECUTIVE PATIENTS UNDERGOING PCI WITH DES BETWEEN 2002 AND 2009, CLINICAL OUTCOMES WERE AS FOLLOWS: 323 (5.3%) PATIENTS WERE DIAGNOSED WITH AF.. DEATH WITH AF: 22.5%; WITHOUT AF: 9.6%. MYOCARDIAL INFARCTION WITH AF: 6.5%; WITHOUT AF: 4.8%. TARGET LESION REVASCULARIZATION WITH AF: 10.3%; WITHOUT AF: 9.4%. TARGET VESSEL REVASCULARIZATION WITH AF: 16.3%; WITHOUT AF: 14.8%. ISCHEMIC STROKE WITH AF: 3.4%; WITHOUT AF: 0.8%. TRANSIENT ISCHEMIC ATTACK WITH AF: 0.6%; WITHOUT AF: 0.4%. NEUROLOGIC EVENT WITH AF: 0.9%; WITHOUT AF: 0.2%. BLEEDING ACADEMIC RESEARCH CONSORTIUM (BARC) EVENTS REQUIRING SURGICAL INTERVENTION OR INTRAVENOUS VASOACTIVE AGENTS WITH AF: 24.5%, WITHOUT AF: 3.72%. DEFINITE OR PROBABLE STENT THROMBOSIS WITH AF: 6.8%; WITHOUT AF: 6.5%. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    92965 XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization| R