BEUDAMED
    FDA Adverse Event Death Summary report: N

    PROTEGE EVERFLEX SELF-EXPANDING STENT SYSTEM STANDARD

    MDR report key: 5748599 · Received June 24, 2016

    Report

    Report Number
    2183870-2016-00452
    Event Type
    Death
    Date Received
    June 24, 2016
    Date of Event
    January 1, 2015
    Report Date
    May 29, 2016
    Manufacturer
    COVIDIEN
    Product Code
    FGE
    PMA / PMN Number
    K060057
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    ABSTRACT PURPOSE: DESCRIBE OUTCOMES AFTER ENDOVASCULAR INTERVENTION OF TRANSATLANTIC INTER-SOCIETY CONSENSUS C AND D FEMORO-POPLITEAL DISEASE. MATERIALS AND METHODS: RETROSPECTIVE COHORT STUDY. PATIENT DEMOGRAPHICS, ANKLE-BRACHIAL INDICES, AND LESION DETAILS WERE ANALYZED FROM A PROSPECTIVELY MAINTAINED DATABASE. IN ALL, 980 LIMBS TREATED WITH PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY_STENTING OF THE FEMORO-POPLITEAL SEGMENT BETWEEN 2005 AND 2012 WERE REVIEWED. SEVENTY-SIX PATIENTS REPRESENTING 83 LIMBS WITH DE NOVO TRANSATLANTIC INTER-SOCIETY CONSENSUS C AND D LESIONS MEASURING _15 CM CONTINUOUSLY WERE IDENTIFIED (MEAN AGE 71.3_12.1 YEARS, 62% MALE). RESULTS: TWENTY-FIVE (30.1%) LIMBS WERE TREATED FOR SEVERE CLAUDICATION AND 58 (69.9%) FOR CRITICAL LIMB ISCHEMIA. THE MEAN PRE-PROCEDURAL ANKLE-BRACHIAL INDEX WAS 0.47_0.19. THE MEAN LESION LENGTH WAS 22.9_4.82 CM. SEVENTY PATIENTS REPRESENTING 77 LIMBS WERE AVAILABLE FOR A MEAN FOLLOW-UP LENGTH OF 19.5 MONTHS (RANGE 0¿79). THE MEAN POST-PROCEDURAL ANKLE-BRACHIAL INDEX WAS 0.71_0.28. PRIMARY, ASSISTED-PRIMARY, AND SECONDARY PATENCY RATES WERE 68.1%, 72.7%, AND 83.3% AT 6 MONTHS, 55.3%, 63.6%, AND 58.3% AT 12 MONTHS, AND 38.2%, UNAVAILABLE, AND 10.4% AT 24 MONTHS, RESPECTIVELY. CONCLUSIONS: ANGIOPLASTY-FIRST STRATEGY FOR TRANSATLANTIC INTER-SOCIETY CONSENSUS C AND D LESIONS OF THE FEMOROPOPLITEAL ARTERY CAN BE SAFELY PERFORMED. HOWEVER, PATENCY DRASTICALLY DECREASES AFTER 12 MONTHS SUGGESTING FURTHER IMPROVEMENTS ARE REQUIRED TO ACHIEVE LONGER-TERM CLINICAL BENEFIT. A VARIETY OF STENT-TYPES WERE DEPLOYED AND INCLUDE EPIC (BOSTON SCIENTIFIC CORP.), LIFESTENT (BARD), PROTEGE EVERFLEX (EV3 INC.), SE NTINOL (BOSTON SCIENTIFIC CORP.), SMART (CORDIS CORP.), SUPERA (IDEV TECHNOLOGY), AND ZILVER (COOK MEDICAL). NO ATHERECTOMY DEVICES WERE UTILIZED. OF THE 83 LIMBS, ONE REQUIRED AN ANTEGRADE-RETROGRADE APPROACH TO ACHIEVE REVASCULARIZATION. FORTY-THREE (51.8%) LIMBS REQUIRED ONE OR MORE (CUMULATIVE TOTAL 67) ADJUNCTIVE ENDOVASCULAR INTERVENTIONS (ANGIOPLASTY_STENTING). THIS INCLUDES THE COMMON ILIAC ARTERY (N¼2), IPSILATERAL EXTERNAL ILIAC ARTERY (N¼2), CONTRALATERAL EXTERNAL ILIAC ARTERY (N¼1), IPSILATERAL COMMON FEMORAL ARTERY (N¼2), POPLITEAL (N¼25), TIBIOPERONEAL TRUNK (N¼8), ANTERIOR TIBIAL ARTERY (N¼10), POSTERIOR TIBIAL ARTERY (N¼7), AND PERONEAL ARTERY (N¼25). OF THE 67 REQUIRED ADJUNCTIVE INTERVENTIONS, ONLY FOUR (6.0%) STENOSES/OCCLUSIONS NOTED IN INFRAPOPLITEAL VESSELS WERE UNABLE TO BE TRAVERSED. THREE (4.5%) PATIENTS REQUIRED ADJUNCTIVE ENDOVASCULAR TREATMENT DUE TO DISTAL EMBOLI NOTED FOLLOWING FPA ANGIOPLASTY. ELEVEN OF 25 (44.0%) LIMBS WITH CLAUDICATION REQUIRED ADJUNCTIVE INTERVENTION COMPARED TO 32 OF 57 (56.1%) LIMBS WITH CLI. OF THE TOTAL NUMBER OF ADJUNCTIVE INTERVENTIONS, 0/2 COMMON ILIAC, 2/2 IPSILATERAL EXTERNAL ILIAC, 0/1 CONTRALATERAL EXTERNAL ILIAC, 2/2 IPSILATERAL COMMON FEMORAL, 18/25 POPLITEAL, 7/8 TIBIOPERONEAL TRUNK, 8/10 ANTERIOR TIBIAL, 6/7 POSTERIOR TIBIAL, AND 10/10 PERONEAL INTERVENTIONS WERE REQUIRED IN LIMBS WITH CLI. TECHNICAL SUCCESS WAS ACHIEVED IN 78 (94.0%) INTERVENTIONS. PERIPROCEDURAL COMPLICATIONS INCLUDED: IN-STENT THROMBOSIS IN THREE PATIENTS (ONE WITH CLAUDICATION AND TWO WITH CLI) REQUIRING TISSUE PLASMINOGEN ACTIVATOR AND EMBOLECTOMY; THROMBUS IN THE CONTRALATERAL COMMON FEMORAL ARTERY IN ONE PATIENT REQUIRING THROMBOLYSIS AND ENDARTERECTOMY; PERONEAL EMBOLI IN TWO PATIENTS ON POST-PROCEDURAL ANGIOGRAPHY, ONE WHO WAS TREATED WITH PTA OF THE TIBIOPERONEAL TRUNK AND HEPARIN WHILE THE OTHER PATIENT WAS OBSERVED IN THE DAY UNIT AND REMAINED ASYMPTOMATIC; GROIN HEMATOMA IN TWO PATIENTS, ONE WHO SUBSEQUENTLY EXPERIENCED A VASOVAGAL EPISODE DURING MANUAL COMPRESSION AFTER FAILED CLOSURE DEVICE INSERTION; PSEUDOANEURYSM OF THE PUNCTURE SITE IN ONE PATIENT TREATED BY THROMBIN INJECTION; ARTERIAL ACCESS FAILED IN ONE PATIENT REQUIRING A RETROGRADE POPLITEAL APPROACH RESULTING IN SUCCESSFUL INTERVENTION; A TOTAL OF TWO DEATHS OCCURRED WITHIN ONE MONTH OF THE PROCEDURE (30 DAY MORTALITY RATE OF 1.3%) IN WHICH ONE PATIENT DIED 17 DAYS FOLLOWING INTERVENTION DUE TO CONGESTIVE HEART FAILURE AND ONE PATIENT DIED SOON AFTER THE INTERVENTION FOR UNKNOWN REASONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    401810 PROTEGE EVERFLEX SELF-EXPANDING STENT SYSTEM STANDARD CATHETER, BILIARY, DIAGNOSTIC FGE COVIDIEN

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Death