BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVOLUTION® COLONIC CONTROLLED-RELEASE STENT - UNCOVERED

    MDR report key: 18442208 · Received January 4, 2024

    Report

    Report Number
    3001845648-2024-00009
    Event Type
    Malfunction
    Date Received
    January 4, 2024
    Date of Event
    November 5, 2016
    Report Date
    July 25, 2024
    Manufacturer
    COOK IRELAND LTD
    Product Code
    MQR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    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. DEVICE EVALUATION: THE DEVICE EVALUATION COULD NOT BE COMPLETED AS THE DEVICE OR PHOTOGRAPHIC EVIDENCE OF THE DEVICE WAS NOT RETURNED FOR EVALUATION. WITH THE INFORMATION PROVIDED, A DOCUMENT-BASED INVESTIGATION WAS CONDUCTED. THIS FILE IS RELATED TO (B)(4) AND IT WAS CREATED FROM THE ATTACHED JOURNAL ARTICLE. MANUFACTURING RECORDS REVIEW: PRIOR TO DISTRIBUTION ALL EVOLUTION COLONIC CONTROLLED-RELEASE STENT - UNCOVERED DEVICES ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL INSPECTION TO ENSURE DEVICE INTEGRITY. MANUFACTURING RECORDS REVIEW COULD NOT BE COMPLETED AS THE LOT NUMBER IS UNKNOWN. HISTORICAL DATA REVIEW: HISTORICAL DATA WAS NOT REVIEWED AS THE LOT NUMBER IS UNKNOWN. INSTRUCTIONS FOR USE AND/LABEL REVIEW: IT SHOULD BE NOTED THAT THE INSTRUCTIONS FOR USE (IFU0052) LIST ¿INADEQUATE STENT EXPANSION¿ AS A POTENTIAL ADVERSE EVENT. THERE IS NO EVIDENCE TO SUGGEST THAT THE CUSTOMER DID NOT FOLLOW THE INSTRUCTIONS FOR USE OR LABEL. IMAGE REVIEW: AN IMAGE WAS NOT RETURNED FOR EVALUATION. ROOT CAUSE ANALYSIS: A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. A POSSIBLE ROOT CAUSE CAN BE ATTRIBUTED TO THE PROCEDURE AND/OR PATIENTS PRE-EXISTING CONDITIONS. FROM THE LITERATURE PAPER, TECHNICAL FAILURES SUCH AS FAILURE OF STENT EXPANSION WERE DETERMINED TO BE RELATED TO PROCEDURAL COMPLICATIONS. IT SHOULD ALSO BE NOTED THAT THE PAPER CONCLUDED THAT CARCINOMATOSIS WAS ASSOCIATED WITH LOWER TECHNICAL SUCCESS COMPARED TO NON-CARCINOMATOSIS. AS PREVIOUSLY NOTED, THE IFU LISTS INADEQUATE STENT EXPANSION AS A POTENTIAL ADVERSE EVENT. CONFIRMATION OF COMPLAINT: THE COMPLAINT IS CONFIRMED BASED ON CUSTOMER AND/OR REP TESTIMONY. CONFIRMED QUANTITY OF 11 X USED DEVICES. SUMMARY OF INVESTIGATION: ACCORDING TO THE LITERATURE PAPER, FAILURE OF STENT EXPANSION WAS REPORTED IN 11 CASES. FROM THE JOURNAL ARTICLE AND AS PER CLINICAL INPUT, SURGICAL INTERVENTION WOULD HAVE BEEN PERFORMED AS A RESULT OF THIS OCCURRENCE. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR SIMILAR EVENTS.

    Description of Event or Problem · 0

    ABBAS, 2016 ¿ PREDICTORS OF OUTCOME FOR ENDOSCOPIC COLORECTAL STENTING: A DECADE EXPERIENCE. A RETROSPECTIVE REVIEW WAS CONDUCTED OF ALL ENDOSCOPIC STENTING PROCEDURES PERFORMED BY A COLORECTAL SURGEON AT A TERTIARY REFERRAL INSTITUTION BETWEEN 2003 AND 2013. MAIN OUTCOME MEASURES INCLUDED TECHNICAL SUCCESS, CLINICAL SUCCESS, COMPLICATIONS, AND PREDICTORS OF OUTCOME. 11 CASES OF FAILURE OF STENT EXPANSION REQUIRING INTERVENTION. REQUIRED INTERVENTION.

    Description of Event or Problem · 0

    SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION ON 25-JUL-2024.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    615597 EVOLUTION® COLONIC CONTROLLED-RELEASE STENT - UNCOVERED MQR STENT, COLONIC METALLIC EXPANDABLE MQR COOK IRELAND LTD UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Male