BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROTEGE GPS SELF-EXPANDING BILIARY STENT SYSTEM 018

    MDR report key: 5748763 · Received June 24, 2016

    Report

    Report Number
    2183870-2016-00456
    Event Type
    Malfunction
    Date Received
    June 24, 2016
    Report Date
    May 29, 2016
    Manufacturer
    COVIDIEN
    Product Code
    FGE
    PMA / PMN Number
    K051379
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    LITERATURE REFERENCE: LIN, Y., ET AL. (2015). "STENT FRACTURES AFTER SUPERFICIAL FEMORAL ARTERY STENTING: RISK FACTORS AND IMPACT ON PATENCY." J ENDOVASC THER 22(3): 319-326.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    EVENT REPORTED THROUGH LITERATURE. PURPOSE: TO DETERMINE THE RISK FACTORS AND CLINICAL IMPACT OF STENT FRACTURES AFTER SUPERFICIAL FEMORAL ARTERY (SFA) STENTING. METHODS: FROM MAY 2009 TO JUNE 2012, 171 CONSECUTIVE PATIENTS (MEAN AGE 74.5±7.8, YEARS; 106 MEN) WHO PRESENTED WITH SFA STENOSIS OR OCCLUSION IN 205 LIMBS UNDERWENT STENT IMPLANTATION IN THE SFA AT A SINGLE CENTER. STENT FRACTURES WERE DETERMINED BY RADIOGRAPHY AND CLASSIFIED INTO TYPES I THROUGH V. LOSS OF PATENCY WAS ASSESSED BY DUPLEX ULTRASONOGRAPHY (>2.4 PEAK SYSTOLIC VELOCITY RATIO) OR ANGIOGRAPHY (PERCENT DIAMETER STENOSIS >50%). RESULTS: THE 12- AND 24-MONTH PRIMARY PATENCY RATES WERE 49.8% AND 43.4%, RESPECTIVELY. STENT FRACTURES OCCURRED IN 12.5% AND 26.8% PER LIMB (6.6% AND 19.4% PER STENT) AT 12 AND 24 MONTHS, RESPECTIVELY. CONCLUSION: STENT FRACTURES OCCUR MORE FREQUENTLY IN PATIENTS WITH CTOS AFTER TREATMENT OF LONGER STENTED LESIONS. ALTHOUGH MULTIVARIATE ANALYSIS SHOWED THAT CTO WAS THE ONLY INDEPENDENT PREDICTOR REGARDLESS OF STENT LENGTH OR NUMBER, THE STENT FRACTURE RATE WAS NUMERICALLY HIGHER IN THE SEVERE CALCIFICATION AND PROXIMAL SFA LESION SUBGROUPS. STENT FRACTURE DID NOT APPEAR TO AFFECT LONG-TERM PATENCY RATES, BUT THIS IS YET TO BE CONFIRMED WITH FURTHER FOLLOW-UP. THE PRIMARY PATENCY OF THE ENTIRE COHORT WAS 49.8% AT 12 MONTHS AND 43.4% AT 24 MONTHS . STENT FRACTURES OCCURRED IN 12.5% (25/205) AND 26.8% (55/205) PER LIMB OR 6.6% (25/376) AND 19.4% (73/376) PER STENT AT 12 AND 24 MONTHS, RESPECTIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    401825 PROTEGE GPS SELF-EXPANDING BILIARY STENT SYSTEM 018 CATHETER, BILIARY, DIAGNOSTIC FGE COVIDIEN

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR