BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 3122978 · Received May 21, 2013

    Report

    Report Number
    2024168-2013-03215
    Event Type
    Injury
    Date Received
    May 21, 2013
    Date of Event
    December 17, 2012
    Report Date
    April 22, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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 EFFECTS OF THROMBOSIS AND RESTENOSIS, ARE LISTED IN THE (B)(4) XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM INSTRUCTIONS FOR USE (IFU) AS KNOWN ADVERSE EVENTS. 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. THE 3.5 X 28 MM AND THE 3.0 X 18 MM XIENCE STENTS INDICATED IN THE EVENT DESCRIPTION ARE BEING REPORTED UNDER THE SAME MANUFACTURER REPORT NUMBER.

    Description of Event or Problem · 1

    IT WAS REPORTED IN LITERATURE REVIEW THAT 6 MONTHS AFTER EVEROLIMUS-ELUTING STENT (EES) IMPLANTATION (3.5 X 28 MM, 3.5 X 28 MM, 3.0 X 18 MM) IN THE RIGHT CORONARY ARTERY (RCA), REPEAT RADIOISOTOPE IMAGING (RI) SUSPECTED INSTENT RESTENOSIS, AND CORONARY ANGIOGRAPHY (CAG) CONFIRMED HIGH GRADE FOCAL STENOSIS IN THE MID RCA. THE LESION WAS TREATED WITH BALLOON DILATATION GUIDED BY OPTICAL COHERENCE TOMOGRAPHY (OCT) IN-STENT RESTENOSIS WAS TREATED USING A NON-ABBOTT CUTTING BALLOON AND A DISTAL PROTECTION DEVICE. IMMEDIATELY AFTER BALLOON DILATATION, THE PERCENTAGE OF DIAMETER STENOSIS IMPROVED FROM 72.1 % TO 12.7 %. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    224371 XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization| R STENT: XIENCE [3.5 X 28 MM, 3.0 X 18 MM]