BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2931542 · Received January 28, 2013

    Report

    Report Number
    2024168-2013-00427
    Event Type
    Injury
    Date Received
    January 28, 2013
    Date of Event
    January 1, 2012
    Report Date
    December 21, 2012
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DATE OF EVENT ESTIMATED AS DATE OF PUBLICATION. DATE OF IMPLANT ESTIMATED AS ONE YEAR PRIOR TO DATE OF PUBLICATION. (B)(4). INDICATION FOR USE. THERE WERE NO REPORTED PRODUCT DEFICIENCIES. THE REPORTED PATIENT EFFECTS OF STENOSIS/RESTENOSIS IS LISTED IN THE XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM INSTRUCTIONS FOR USE (IFU) AS A KNOWN ADVERSE EVENT. 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. IT WAS REPORTED THAT THE DEVICE WAS IMPLANTED TO TREAT A BELOW-THE-KNEE LESION. IT SHOULD BE NOTED THAT THE IFU STATES XIENCE V IS INDICATED FOR IMPROVING CORONARY LUMINAL DIAMETER IN PATIENTS WITH SYMPTOMATIC HEART DISEASE DUE TO DE NOVO (NEW) NATIVE CORONARY ARTERY LESIONS. IN THIS CASE, IT IS UNKNOWN IF THE REPORTED IFU DEVIATION DIRECTLY CAUSED OR CONTRIBUTED TO THE REPORTED PATIENT EFFECTS. THE PROMUS REFERENCED IS BEING FILED UNDER A SEPARATE MEDWATCH REPORT.

    Description of Event or Problem · 1

    THIS EVENT WAS CAPTURED BASED ON REVIEW OF THE ARTICLE, LONG-TERM OUTCOMES FOLLOWING PRIMARY DRUG-ELUTING STENTING OF INFRAPOPLITEAL BIFURCATIONS. PURPOSE: TO INVESTIGATE THE OUTCOMES FOLLOWING PRIMARY DEPLOYMENT OF DRUG-ELUTING STENTS (DES) FOR THE TREATMENT OF INFRAPOPLITEAL BIFURCATION LESIONS IN PATIENTS SUFFERING FROM CRITICAL LIMB ISCHEMIA (CLI). METHODS: THIS WAS A RETROSPECTIVE STUDY OF A REGISTRY ENROLLING ALL PATIENTS SUFFERING FROM CHRONIC INFRAPOPLITEAL ARTERY DISEASE AND UNDERGOING TREATMENT OF TIBIAL BIFURCATION LESIONS WITH DES USING 3 TECHNIQUES: BALLOON AND STENT (SINGLE STENT), T-SHAPE DOUBLE-STENT, AND CULOTTE DOUBLE-STENT. THE ANALYSIS INCLUDED 39 CLI PATIENTS WHO UNDERWENT PRIMARY STENTING OF 41 INFRAPOPLITEAL BIFURCATIONS. RESULTS: TECHNICAL SUCCESS WAS ACHIEVED IN ALL CASES. ACCORDING TO THE KAPLAN-MEIER ANALYSIS, OVERALL SURVIVAL, AMPUTATION-FREE SURVIVAL, AND TARGET LESION REVASCULARIZATION (TLR)-FREE SURVIVAL ESTIMATES WERE 79.5%, 84.3%, AND 58.0%, RESPECTIVELY, AT 5 YEARS. AT 12, 24, AND 36 MONTHS, THE 2VPP RATES WERE 77.2%, 47.5%, AND 33.9%, AND THE 1VPP RATES WERE 84.0%, 65.5%, AND 54.5%, RESPECTIVELY. BINARY RESTENOSIS RATES WERE 26.4%, 57.3%, AND 82.2% AT 12, 24, AND 36 MONTHS; RE-STENOTIC LESIONS WERE MAINLY DETECTED AT THE ORIGIN OF THE BIFURCATIONS. THE REGRESSION MODEL DID NOT IDENTIFY ANY INDEPENDENT PREDICTORS INFLUENCING OUTCOME. CONCLUSION: DES APPLICATION FOR BELOW-THE-KNEE BIFURCATION LESIONS WAS SAFE AND RESULTED IN SATISFACTORY LONG-TERM ANGIOGRAPHIC AND CLINICAL OUTCOMES COMPARABLE TO THOSE REPORTED FOLLOWING INFRAPOPLITEAL ENDOVASCULAR TREATMENT. IT WAS NOTED THAT BOTH XIENCE SDS AND PROMUS SDS WERE USED IN THIS STUDY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    36784 XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization| R STENT: PROMUS