BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 3031285 · Received April 2, 2013

    Report

    Report Number
    2024168-2013-01918
    Event Type
    Injury
    Date Received
    April 2, 2013
    Date of Event
    January 1, 2006
    Report Date
    March 8, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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. THERE WAS NO REPORTED PRODUCT DEFICIENCY AND THE PRODUCT WAS NOT RETURNED. THE REPORTED PATIENT EFFECT OF MYOCARDIAL INFARCTION, AS LISTED IN THE XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM INSTRUCTIONS FOR USE, IS A KNOWN ADVERSE EVENT ASSOCIATED WITH CORONARY STENTING PROCEDURES. THE DEVICE ISSUE (MALAPPOSED STENT STRUTS), IS BEING FILED UNDER A SEPARATE MEDWATCH REPORT#.

    Description of Event or Problem · 1

    THE FOLLOWING INFORMATION WAS OBTAINED THROUGH A LITERATURE REVIEW. THE AIM OF THIS STUDY WAS TO ASSESS STRUT APPOSITION BY OPTICAL COHERENCE TOMOGRAPHY (OCT) ACROSS THE BIFURCATION LESION IMMEDIATELY AFTER STENT IMPLANTATION IN A CONSECUTIVE SERIES OF PATIENTS WITH BIFURCATION LESIONS TREATED WITH TWO DIFFERENT STENTING STRATEGIES [SINGLE STENT APPROACH VERSUS TWO STENT APPROACH]. OUT OF THE 41 PATIENTS ENROLLED IN THIS STUDY, THERE WERE NINE XIENCE V STENTS IMPLANTED. THE FINDINGS OF THE STUDY INDICATED THAT MALAPPOSED STRUTS FOUND VIA OPTICAL COHERENCE TOMOGRAPHY (OCT) WAS HIGHER IN THE PATIENTS WHO HAD THE TWO-STENT APPROACH. THE FINDINGS ALSO INDICATED THAT POST PROCEDURAL, ASYMPTOMATIC MYOCARDIAL INFARCTIONS (MI), TYPE 4A, OCCURRED MORE FREQUENTLY IN THE TWO-STENT GROUP. THERE WERE TWO DEATHS RECORDED; BOTH WERE NON-CARDIAC IN THE TWO-STENT GROUP. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    134087 XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Disability