BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROTEGE EVERFLEX SELF-EXPANDING STENT SYSTEM STANDARD

    MDR report key: 7845606 · Received September 5, 2018

    Report

    Report Number
    2183870-2018-00433
    Event Type
    Injury
    Date Received
    September 5, 2018
    Date of Event
    April 18, 2018
    Report Date
    September 5, 2018
    Manufacturer
    COVIDIEN
    Product Code
    FGE
    PMA / PMN Number
    K060057
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVENT DATE IS LITERATURE ARTICLE PUBLISHED DATE NINE-MONTH OUTCOMES OF THE DURABILITY ILIAC STUDY ON SELF-EXPANDING STENTS FOR SYMPTOMATIC PERIPHERAL ARTERY DISEASE ANNALS OF VASCULAR SURGERY (2018) VOL 51L 37-47 10.1016/J.AVSG.2018.02.020. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    (B)(6) EVALUATED THE SAFETY AND EFFECTIVENESS OF 2 NITINOL SELF-EXPANDING STENTS (PROTÉGÉ EVERFLEX AND PROTÉGÉ GPS) FOR THE TREATMENT OF ATHEROSCLEROTIC COMMON AND EXTERNAL ILIAC ARTERY LESIONS UP TO 10 CM IN LENGTH AND >50% STENOSIS IN SUBJECTS WITH RUTHERFORD CLASSIFICATION PERIPHERAL ARTERIAL DISEASE STAGES 2-4. THE CHOICE OF STENT IN THE STUDY WAS DETERMINED BY LESION SIZE. STENTS WERE DEPLOYED AS PER THE INSTRUCTIONS FOR USE. PREDILATATION OF THE LESION USING STANDARD PTA WAS RECOMMENDED, AND POSTDILATATION WAS PERFORMED AT THE DISCRETION OF THE IMPLANTING PHYSICIAN. THE PRIMARY OUTCOME OF (B)(6) WAS THE MAJOR ADVERSE EVENT (MAE) RATE AT 9 MONTHS, DEFINED AS A COMPOSITE OF PERIPROCEDURAL DEATH, IN-HOSPITAL MYOCARDIAL INFARCTION (MI), CLINICALLY DRIVEN TARGET LESION REVASCULARIZATION (CD-TLR), AND AMPUTATION OF THE TREATED LIMB THROUGH 9 MONTHS AFTER PROCEDURE. SECONDARY OUTCOMES CONSISTED OF THE FOLLOWING: MAE RATE AT 30 DAYS AFTER PROCEDURE; PRIMARY PATENCY RATE AT 9 MONTHS, CHANGE IN THE ABI AT 30 DAYS AND 9 MONTHS, DEVICE SUCCESS, CHANGE IN WIQ SCORE, CLINICALLY DRIVEN TARGET VESSEL REVASCULARIZATION (CD-TVR). A TOTAL OF 82 STENTS (29 PROTÉGÉ EVERFLEX AND 53 PROTÉGÉ GPS) WERE IMPLANTED IN 75 SUBJECTS (77 LESIONS). WHEN BROKEN DOWN BY PATIENT, 28 PATIENTS WERE TREATED WITH PROTÉGÉ EVERFLEX; 46 PATIENTS WERE TREATED WITH PROTÉGÉ GPS, AND 1 PATIENT WAS TREATED WITH BOTH PROTÉGÉ EVERFLEX AND PROTÉGÉ GPS. NO DEVICE MALFUNCTIONS WERE REPORTED, AND ALL STENTS WERE DEPLOYED AS INTENDED AT THE TREATMENT SITE FOR A DEVICE SUCCESS RATE OF 100%. THE PRIMARY OUTCOME RATE OF MAES AT 9MONTHS AFTER PROCEDURE WAS 1.3% (1/75). ONE SUBJECT EXPERIENCED CD-TLR THROUGH 9 MONTHS. THERE WERE NO PERIPROCEDURAL DEATHS, MIS, OR AMPUTATIONS OF THE TREATED LIMB THROUGH 9 MONTHS. SIMILARLY, NONE OF THE SUBJECTS (0.0%, 0/75) EXPERIENCED AN MAE AT 30 DAYS, INCLUDING PERIPROCEDURAL DEATH, MI, OR AMPUTATION. WHEN ANALYZED BY STENT TYPE, PRIMARY PATENCY AT 9 MONTHS WAS 92.4% FOR PROTÉGÉ EVERFLEX AND 97.8% FOR PROTÉGÉ GPS. OUT TO 3 YEARS, THERE WERE 8 MAES, ALL ADJUDICATED BY THE CORE LABORATORY AS CD-TLRS. AS SUCH, THE FREEDOM FROM CD-TVR AND FREEDOM FROM CD-TLR THROUGH 3 YEARS USING KAPLAN-MEIER ANALYSIS WAS 87.9%.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    687753 PROTEGE EVERFLEX SELF-EXPANDING STENT SYSTEM STANDARD CATHETER, BILIARY, DIAGNOSTIC FGE COVIDIEN

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention