BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROTEGE EVERFLEX SELF-EXPANDING STENT SYSTEM STANDARD

    MDR report key: 5747646 · Received June 24, 2016

    Report

    Report Number
    2183870-2016-00443
    Event Type
    Malfunction
    Date Received
    June 24, 2016
    Date of Event
    January 20, 2015
    Report Date
    May 29, 2016
    Manufacturer
    COVIDIEN
    Product Code
    FGE
    PMA / PMN Number
    K072301
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DATE ARTICLE WAS PUBLISHED JOURNAL ARTICLE TITLE: FIRST CLINICAL EXPERIENCE WITH THE INNOVA VERSUS THE PROTEGE EVERFLEX SELF-EXPANDING BARE METAL STENTS IN SUPERFICIAL FEMORAL ARTERY OCCLUSIONS THORAC CARDIOVASC SURG 2015;63:158¿163. ORIGINAL CARDIOVASCULAR DOI HTTP://DX.DOI.ORG/ 10.1055/S-0034-1396898. ISSN 0171-6425

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    FROM MARCH 2012 TO JANUARY 2013, 71 PATIENTS WITH RUTHERFORD CLASS 3 TO 5 TASC (TRANS ATLANTIC INTER-SOCIETAL CONSENSUS)-II B AND C LESIONS WERE EVALUATED IN A SINGLE CENTER BY RETROSPECTIVE DATA ANALYSIS. INCLUSION CRITERIA WERE SYMPTOMATIC, INTERMEDIATE-LENGTH (<(><<)>15 CM) SFA OCCLUSIVE LESIONS, AND AT LEAST TWO PATENT VESSELS BELOW THE KNEE ARTERIES. EXCLUSION CRITERIA WERE PREVIOUS ENDOVASCULAR OR SURGICAL TREATMENT OF THE TARGET SFA, SEVERE RENAL FAILURE, MENTAL DISABILITY, AND CONTRAINDICATION FOR ANTICOAGULATION (INCLUDING USE OF ASPIRIN AND CLOPIDOGREL). IN 30 PATIENTS, SFA PTA WITH STENTING WAS PERFORMED WITH INNOVA SELF-EXPANDING BMS SYSTEM ((B)(4); INNOVA GROUP), AND 41 PATIENTS (PROTEGE GROUP) RECEIVED THE SAME TREATMENT WITH PROTEGE EVERFLEX STENT (EV3 ENDOVASCULAR, INC., (B)(4), UNITED STATES). ALL 71 PATIENTS WERE TREATED BY THE SAME EXPERIENCED VASCULAR SURGEON IN THE SAME PERIOD USING LOCAL ANESTHESIA. THE PROTEGE GROUP SHOWED SIMILAR EFS TO THE INNOVA GROUP THERE WERE NO PROCEDURE- OR DEVICE-RELATED DEATHS, AND AMPUTATION OR RUTHERFORD CLASS WORSENING WAS RARE, WITH SIMILAR FREQUENCIES IN THE STUDY GROUPS. THE MOST COMMON MAJOR ADVERSE EVENT WAS RTL. A FEMORAL PSEUDOANEURYSM OCCURRED IN ONE PATIENT IN THE INNOVA GROUP AND WAS TREATED BY ULTRASOUND-GUIDED THROMBIN INJECTION. ONE POSTOPERATIVE SEROMA IN THE PROTEGE GROUP WAS TREATED WITH CONSERVATIVE APPROACH. NINETY-THREE PERCENT OF PATIENTS WERE DISCHARGED ON POSTOPERATIVE DAY 1; THE REMAINING 7% OF PATIENTS, ON POSTOPERATIVE DAY 2. IN THE PROTEGE GROUP, WE RECORDED 4 RESTENOSES AND 3 REOCCLUSIONS; 5 CASES WERE RETREATED. ONE REOCCLUSION WAS TREATED WITH THROMBOLYSIS FOLLOWED BY PTA AND STENTING. ONE PATIENT UNDERWENT SFA THROMBECTOMY. IN THE REMAINING 3 CASES, A SUBINTIMAL ANGIOPLASTY WAS PERFORMED AND 1 REMAINED PATENT. IN 2 RESTENOSES, REINTERVENTION WAS NOT NEEDED; THESE PATIENTS HAD MILD INTERMITTED CLAUDICATION ONLY. ONE PATIENT WITH REOCCLUSION AFTER THE REINTERVENTION RECEIVED AN INFRAGENICULAR BYPASS. ONE REOCCLUSION WAS RECORDED AND NO REINTERVENTION WAS NEEDED FOR MILD, ASSOCIATED SYMPTOMS. IN THE INNOVA GROUP, WE RECORDED SEVERAL 12 REOCCLUSIONS AND 5 RESTENOSES; 14 CASES OF THESE WERE RETREATED. FIVE REOCCLUSIONS WERE TREATED WITH THROMBOLYSIS FOLLOWED BY PTA AND STENTING; 5 PATIENTS WITH REOCCLUSION UNDERWENT SUBINTIMAL ANGIOPLASTY, FOLLOWED BY ANOTHER INTERVENTION (INFRAGENICULAR BYPASS) IN 1 PATIENT. IN 1 CASE, NO REINTERVENTION WAS PERFORMED; THESE PATIENTS HAD MILD INTERMITTED CLAUDICATION ONLY. OF THE 5 SFA RESTENOSES, 3 WERE TREATED WITH PTA. THREE PATIENTS WITH POST-REINTERVENTION REOCCLUSION RECEIVED AN INFRAGENICULAR BYPASS, AND A MAJOR AMPUTATION WAS PERFORMED IN ONE OF THESE. THE POSTOPERATIVE ABI VALUES, RUTHERFORD SCORES, AND WALKING IMPAIRMENT SCORES SIGNIFICANTLY IMPROVED (P <(><<)> 0.001) AFTER TREATMENT IN BOTH GROUPS, WITH NO SIGNIFICANT DIFFERENCES. AT 12 MONTHS, 67 OF 68 STENTS (98.5%) WERE FREE FROM FRACTURE, WITH A 12-MONTH FRACTURE RATE OF 1.5% (1/ 68). THE STENT FRACTURE WAS TYPE I IN GROUP PROTEGE AND WAS NOT ASSOCIATED WITH ADVERSE EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    402370 PROTEGE EVERFLEX SELF-EXPANDING STENT SYSTEM STANDARD CATHETER, BILIARY, DIAGNOSTIC FGE COVIDIEN

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention