BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 3140170 · Received May 31, 2013

    Report

    Report Number
    2024168-2013-03405
    Event Type
    Injury
    Date Received
    May 31, 2013
    Date of Event
    January 30, 2013
    Report Date
    May 7, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE 2.5 X 23 MM UNKNOWN XIENCE V STENTS MENTIONED ARE BEING FILED UNDER SEPARATE MANUFACTURER REPORT NUMBERS. THE STENT REMAINS IN THE PATIENT. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). THERE WERE NO REPORTED PRODUCT DEFICIENCIES. THE REPORTED PATIENT EFFECTS OF ANGINA, ISCHEMIA, FISTULA, AND STENOSIS/RESTENOSIS ARE LISTED IN THE XIENCE V/XIENCE NANO EVEROLIMUS ELUTING CORONARY STENT SYSTEM INSTRUCTIONS FOR USE (IFU) AS KNOWN PATIENT EFFECTS OF 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2011, A 2.5X23 UNSPECIFIED XIENCE STENT, THEN A 2.5X15 UNSPECIFIED XIENCE STENT WERE IMPLANTED, WITH THE 2.5X15 OVERLAPPING THE 2.5X23 IN THE MID LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY DUE TO PROGRESSIVE LAD DISEASE. ON (B)(6) 2013, THE PATIENT PRESENTED WITH ANGINA. A LENGTHY STENOSIS THROUGH THE PREVIOUSLY STENTED MID RCA (IT IS BELIEVED THAT THE SITE INTENDED TO INDICATE MID LAD AND NOT RCA; PENDING CLARIFICATION FROM SITE) WAS NOTED AND WAS FELT TO BE THE REASON FOR THE RECURRENT ANGINA. AS A RESULT, THE MID LAD WAS STENTED WITH A 2.5X23 UNSPECIFIED XIENCE STENT. ON (B)(6) 2013, THE PATIENT PRESENTED WITH ANGINA, WHICH BEGAN 1 MONTH PRIOR AND HAD BEEN UNSUCCESSFULLY TREATED VIA MEDICAL MANAGEMENT. NUCLEAR IMAGING REVEALED A NEW APICAL FISTULA FROM THE MID LAD EXTENDING INTO THE RIGHT VENTRICLE, RESULTING IN APICAL ISCHEMIA. THE FISTULA AND ISCHEMIA WERE TREATED SUCCESSFULLY VIA IMPLANTATION OF A 3.0X12 OTW JOSTENT GRAFTMASTER, WITH NO ADVERSE PATIENT SEQUELAE. ADDITIONAL INFORMATION HAS BEEN REQUESTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    242185 XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Hospitalization| R STENT: 2.5 X 23 MM XIENCE V