BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROTEGE GPS SELF-EXPANDING STENT SYSTEM 035 STANDARD

    MDR report key: 6507824 · Received April 20, 2017

    Report

    Report Number
    2183870-2017-00181
    Event Type
    Injury
    Date Received
    April 20, 2017
    Date of Event
    January 1, 2012
    Report Date
    May 12, 2017
    Manufacturer
    COVIDIEN
    Product Code
    NIO
    PMA / PMN Number
    P060001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CIOPPA, A., ET AL. (2017). "COMBINED USE OF DIRECTIONAL ATHERECTOMY AND DRUG-COATED BALLOON FOR THE ENDOVASCULAR TREATMENT OF COMMON FEMORAL ARTERY DISEASE: IMMEDIATE AND ONE-YEAR OUTCOMES." EUROINTERVENTION 12(14): 1789-1794. DOI: 10.4244/EIJ-D-15-00187. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. 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

    BETWEEN JANUARY 2012 AND JULY 2014, A STUDY WAS CARRIED OUT TO EVALUATE THE SAFETY, FEASIBILITY, AND ONE-YEAR EFFICACY OF THE ENDOVASCULAR TREATMENT OF COMMON FEMORAL ARTERY (CFA)OBSTRUCTIONS WITH COMBINED USE OF DIRECTIONAL ATHERECTOMY (DA) AND A PACLITAXEL-COATED BALLOON (DCB). THIRTY (30) PATIENTS UNDERWENT PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) OF A CALCIFIED LESION WITH THE USE OF DA AND DCB AT THE CFA. OF THIS COHORT, 25 PATIENTS WERE MALE (84%) AND MEDIAN AGE WAS 78 YEARS (RANGE 55 - 84). PATIENT MEDICAL HISTORY INCLUDED; HYPERTENSION, DYSLIPIDEMIA, SMOKERS (PREVIOUS AND CURRENT), DIABETES (NON-INSULIN AND INSULIN DEPENDENT) AND RENAL FAILURE. TREATMENT INCLUDED THE COMBINED USE OF TURBOHAWK PLAQUE EXCISION SYSTEM AND A PROLONGED (3 MINUTES) DILATION USING IN.PACT ADMIRAL IN ALL CASES. DURING FOLLOW-UP, RESTENOSIS OCCURRED IN TWO PATIENTS SIX MONTHS AFTER THE INDEX PROCEDURE AND IN ONE PATIENT AT 11 MONTHS AFTER THE INDEX PROCEDURE. IN-STENT RESTENOSIS OCCURRED IN ONE OF THE PATIENTS TREATED WITH BAIL-OUT STENTING. TWO TARGET LESION RE VASCULARIZATION (TLR) WERE PERFORMED IN TWO PATIENTS SYMPTOMATIC FOR EARLY ONSET CLAUDICATION. FOR THE OTHER PATIENT, NO TLR WAS PERFORMED DUE TO THE LACK OF SYMPTOMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    289840 PROTEGE GPS SELF-EXPANDING STENT SYSTEM 035 STANDARD STENT, ILIAC NIO COVIDIEN

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention