BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVERFLEX SELF-EXPANDING PERIPHERAL STENT WITH ENTRUST DELIVERY SYSTEM LONG

    MDR report key: 20201494 · Received September 12, 2024

    Report

    Report Number
    2183870-2024-00295
    Event Type
    Injury
    Date Received
    September 12, 2024
    Date of Event
    October 16, 2023
    Report Date
    September 12, 2024
    Manufacturer
    COVIDIEN
    Product Code
    NIP
    PMA / PMN Number
    P110023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    REFERENCE: DOI.ORG/10.1024/0301-1526/A001096 A2: AVERAGE AGE A3A: MAJORITY SEX MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    LITERATURE WAS REVIEWED REGARDING ENDOVASCULAR THERAPY FOR POPLITEAL ARTERY DISEASE. THE TIME FRAME OF THIS STUDY WAS FEBRUARY 2009 TO MAY 2018. MULTIPLE MANUFACTURER¿S DEVICES WERE USED IN THE STUDY POPULATION. THE FOLLOWING MEDTRONIC DEVICES WERE USED: EVER FLEX PERIPHERAL STENT. AN OVERALL LONG TERM RESTENOSIS RATE OF (B)(4) WAS REPORTED. OVERALL PERIPROCEDURAL COMPLICATION RATE WAS ACROSS THE WHOLE STUDY POPULATION OF (B)(4) AND CONSISTED OF ACCESS SITE COMPLICATIONS, I.E. PSEUDOANEURYSMS (N=13), ARTERIO-VENOUS FISTULAS (N=2) OR BLEEDING REQUIRING TRANSFUSION (N=2), WHICH WERE ALL TREATED SUCCESSFULLY EITHER BY ULTRASOUND-GUIDED MANUAL COMPRESSION OR THROMBIN INJECTION. NO MAJOR PERIPROCEDURAL COMPLICATIONS WERE OBSERVED. OF THE ADVERSE EVENTS THAT WERE MENTIONED WITHIN THE ARTICLE, NONE OF THEM RELATE DIRECTLY TO THE MEDTRONIC EVERFLEX PERIPHERAL STENTS USED. 9 DEATHS OCCURRED IN THE STUDY POPULATION DURING FOLLOW-UP. THE CAUSES OF DEATH WERE NOT SPECIFIED HOWEVER IT WAS CONFIRMED BUT THE AUTHOR THAT NONE OF THE DEATHS RELATED DIRECTLY TO THE MEDTRONIC EVERFLEX PERIPHERAL STENTS USED. NO FURTHER INFORMATION WAS PROVIDED PERTAINING TO MEDTRONIC PRODUCTS.'

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1515190 EVERFLEX SELF-EXPANDING PERIPHERAL STENT WITH ENTRUST DELIVERY SYSTEM LONG STENT, SUPERFICIAL FEMORAL ARTERY NIP COVIDIEN

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Male Required Intervention