BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 3380040 · Received October 1, 2013

    Report

    Report Number
    2024168-2013-06252
    Event Type
    Injury
    Date Received
    October 1, 2013
    Date of Event
    March 2, 2013
    Report Date
    September 6, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THERE WAS NO REPORTED PRODUCT DEFICIENCY. THE REPORTED RESTENOSIS, ANGINA, DYSPNEA, NAUSEA AND FATIGUE, ARE LISTED IN THE XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM INSTRUCTIONS FOR USE AS KNOWN ADVERSE EVENTS ASSOCIATED WITH CORONARY STENTING. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. THE PROMUS STENT REFERENCED IS BEING FILED UNDER A SEPARATE MEDWATCH REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2012, 416 DAYS POST PROCEDURE, THE PATIENT WAS EXPERIENCING ANGINA AND WAS REHOSPITALIZED AS AN OUTPATIENT. ANGIOGRAPHY REVEALED THE PREVIOUSLY DEPLOYED NON-ABBOTT STENT WAS WIDELY PATENT FROM MID TO DISTAL; HOWEVER, REVEALED PROXIMAL EDGE AND FOCAL (70%) INSTENT RESTENOSIS OF THE NON-ABBOTT STENT AND EDGE STENT RESTENOSIS OF THE PROMUS STENT OVERLAPPING THE DISTAL EDGE OF THE NON-ABBOTT STENT, WHICH WAS TREATED WITH THE PLACEMENT OF A 3.5X28 MM XIENCE V STENT. ANGIOGRAPHY NOTED LESS THAN A 10% RESIDUAL STENOSIS. ON (B)(6) 2013, THE PATIENT WAS REHOSPITALIZED FOR CHEST PAIN AND SYNCOPE; HOWEVER, NOT TREATMENT WAS PERFORMED. ON (B)(6) 2013, THE PATIENT PRESENTED WITH 2 WEEKS HISTORY OF SHORTNESS OF BREATH AND EXERCISE INTOLERANCE ASSOCIATED WITH BURNING OF THE TONGUE, COLD SWEATS, NAUSEA, EXTREME FATIGUE AND HAIR FALL AND WAS REHOSPITALIZED ON THE SAME DAY. ANGIOGRAPHY ON (B)(6) 2013 REVEALED 90% STENOSIS IN THE PROXIMAL EDGE OF THE PATENT STENT EXCEPT FOR 30% STENOSIS IN THE DISTAL PORTION OF THE PATENT STENT. NO TREATMENT WAS PERFORMED. ON (B)(6) 2013, THE SUBJECT WAS DIAGNOSED WITH PROGRESSION OF THE CORONARY ARTERY DISEASE AND WAS REHOSPITALIZED ON THE SAME DAY AND CORONARY ARTERY BYPASS WAS PERFORMED FROM THE LEFT INTERNAL MAMMARY ARTERY TO THE LAD. POST PROCEDURE THE PATIENT WAS DIAGNOSED WITH POST OPERATIVE BLEEDING AND RETURNED TO SURGERY FOR RE-EXPLORATION OF THE BLEED. THE BLEEDING WAS COMING THROUGHOUT RAW SURFACES. THE BYPASS ANASTOMOSIS WERE INTACT WITHOUT BLEEDING. THE RAW SURFACES WERE CAUTERIZED AND THE CHEST WAS CLOSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    494705 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 STENT: PROMUS