BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVOLUTION® COLONIC CONTROLLED-RELEASE STENT - UNCOVERED

    MDR report key: 18452701 · Received January 5, 2024

    Report

    Report Number
    3001845648-2024-00016
    Event Type
    Malfunction
    Date Received
    January 5, 2024
    Date of Event
    October 17, 2016
    Report Date
    April 22, 2024
    Manufacturer
    COOK IRELAND LTD
    Product Code
    MQR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PMA 510K #K163468. INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.

    Additional Manufacturer Narrative · 0

    PMA/510(K) # K163468. CANCELLATION REPORT IS BEING SUBMITTED DUE TO THE RECEIPT OF CONFIRMATION FROM OUR MEDICAL OFFICER THAT THE AE¿S WERE RELATED TO THE SURGICAL PROCEDURE AS OPPOSED STENT PLACEMENT. THE EVENT NO LONGER MEETS THE CRITERIA OF AN FDA ¿SERIOUS INJURY¿ REPORT OR ¿MALFUNCTION¿ REPORT AS PER FDA GUIDELINES ¿MEDICAL DEVICE REPORTING FOR MANUFACTURERS (2016)¿ BASED ON MEDICAL ADVISOR INPUT STATING THAT THE DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE OCCLUSIONS AND SEPSIS AND NO DEVICE MALFUNCTION HAS BEEN IDENTIFIED.

    Description of Event or Problem · 0

    CONSOLE 2016 ¿ COLONIC ACUTE MALIGNANT OBSTRUCTIONS: EFFECTIVENESS OF SELF-EXPANDING METALLIC STENT AS BRIDGE TO SURGERY IN BG (62 PATIENTS), AN ENDOSCOPIC STENT INSERTION WAS PERFORMED IN ALL CASES (TABLE 4); COVERED STENTS WERE PLACED IN 4 (6.4%) CASES, AND THE MOST COMMONLY USED WAS THE NITINOL TYPE. ALL PATIENTS IN BG TAKING ANTICOAGULANT DRUGS SHIFTED TO LMWH. 9 CASES OF OCCLUSION AND 7 CASES OF SEPSIS REQUIRING INTERVENTION REQUIRE INTERVENTION/ADDITIONAL PROCEDURES S=4. INCLUSION CRITERIA WERE THE EMERGENCY PRESENTATION OF OCCLUSION SYMPTOMS (LESS THAN 72 HOURS), AN AMERICAN SOCIETY OF ANESTHESIOLOGISTS (ASA) PHYSICAL STATUS OF =3, AND AGE OF >50 YEARS.

    Description of Event or Problem · 0

    CANCELLATION REPORT IS BEING SUBMITTED DUE TO THE RECEIPT OF CONFIRMATION FROM OUR MEDICAL OFFICER THAT THE AE¿S WERE RELATED TO SURGICAL PROCEDURE AS OPPOSED STENT PLACEMENT. THE EVENT NO LONGER MEETS THE CRITERIA OF AN FDA ¿SERIOUS INJURY¿ REPORT OR ¿MALFUNCTION¿ REPORT AS PER FDA GUIDELINES ¿MEDICAL DEVICE REPORTING FOR MANUFACTURERS (2016)¿ BASED ON MEDICAL ADVISOR INPUT STATING THAT THE DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE OCCLUSIONS AND SEPSIS AND NO DEVICE MALFUNCTION HAS BEEN IDENTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    588382 EVOLUTION® COLONIC CONTROLLED-RELEASE STENT - UNCOVERED MQR STENT, COLONIC METALLIC EXPANDABLE MQR COOK IRELAND LTD UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown