BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1973089 · Received January 28, 2011

    Report

    Report Number
    2024168-2011-00518
    Event Type
    Injury
    Date Received
    January 28, 2011
    Date of Event
    July 20, 2010
    Report Date
    January 5, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    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. STENT: 2.5 X 15 XIENCE V (1009539-15/9092841/45472); 2.5 X 12 XIENCE V (1009539-12/9092341/43800). (B)(4) - INCORRECT ANATOMY AND INDICATIONS FOR USE (NON-NATIVE LESION AND RESTENOSED VESSEL). THE DEVICE REMAINS IN THE PATIENT. THE LOT NUMBER WAS PROVIDED. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). THERE WAS NO REPORTED PRODUCT DEFICIENCY. ANGINA AND RESTENOSIS ARE KNOWN ADVERSE EVENTS AS LISTED IN THE XIENCE V INSTRUCTIONS FOR USE (IFU). 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. SINCE IT WAS REPORTED THAT THE XIENCE V STENT WAS IMPLANTED TO TREAT RESTENOSIS OF A BYPASS GRAFT, IT SHOULD BE NOTED THAT THE XIENCE V IFU STATES: THE XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM (XIENCE V STENT) IS INDICATED FOR IMPROVING CORONARY LUMINAL DIAMETER IN PATIENTS WITH SYMPTOMATIC HEART DISEASE DUE TO DE NOVO NATIVE CORONARY ARTERY LESIONS (LENGTH LESS THAN OR EQUAL TO 28 MM) WITH REFERENCE VESSEL DIAMETERS OF 2.5 MM TO 4.25 MM. THE IFU CAUTIONS THAT: THE SAFETY AND EFFECTIVENESS OF THE XIENCE V STENT HAVE NOT BEEN ESTABLISHED FOR SUBJECT POPULATIONS WITH IN-STENT RESTENOSIS. IT CANNOT BE DETERMINED WHETHER THE IFU DEVIATIONS CONTRIBUTED TO THE REPORTED PATIENT EFFECTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2010, THE PATIENT UNDERWENT STENTING IN THE PREDILATED, RESTENOSED, SECOND DIAGONAL ARTERY BYPASS GRAFT WITH THREE XIENCE V STENTS, SIZES 2.5 X 28, 2.5 X 15, AND 2.5 X 12. ON (B)(6) 2010, THE PATIENT EXPERIENCED RECURRENT UNSTABLE ANGINA AND WAS ADMITTED TO THE HOSPITAL. THE PATIENT WAS FOUND TO BE AFEBRILE WITH STABLE VITAL SIGNS, REGULAR HEART RATE AND A PACED CARDIAC RHYTHM. THE PATIENT UNDERWENT PERCUTANEOUS CORONARY INTERVENTION IN THE PROXIMAL AND MID LEFT ANTERIOR DESCENDING ARTERY WITH 95% AND 90% LESIONS RESPECTIVELY. THE SECOND DIAGONAL INDEX LESION WAS FOUND TO HAVE A DIFFUSE 50% STENOSIS IN THE DISTAL THIRD OF THE GRAFT, BUT DID NOT REQUIRE INTERVENTION. THE PATIENT'S CONDITION RESOLVED ON (B)(6) 2010. THERE WAS NO ADVERSE PATIENT SEQUELA. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 9090141

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Hospitalization| O