BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOLUTION DUODENAL CONTROLLED-RELEASE STENT - UNCOVERED

    MDR report key: 11312457 · Received February 11, 2021

    Report

    Report Number
    3001845648-2021-00083
    Event Type
    Injury
    Date Received
    February 11, 2021
    Date of Event
    August 7, 2019
    Report Date
    May 14, 2021
    Manufacturer
    COOK IRELAND LTD
    Product Code
    MUM
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    510(K) NUMBER: K163468. DEVICE EVALUATION: THE DUODENAL DEVICES INVOLVED IN THIS COMPLAINT WAS NOT RETURNED TO CIRL FOR EVALUATION. WITH THE INFORMATION PROVIDED, A DOCUMENT BASED INVESTIGATION WILL BE COMPLETE. COMPLAINT FILES (B)(4) WERE OPENED AS A RESULT OF THIS PAPER. THIS FILE (B)(4) WAS OPENED TO INVESTIGATE INFECTIOUS PNEUMONIA . DOCUMENTS REVIEW INCLUDING IFU REVIEW: AS THE RPN AND LOT NUMBER OF THE COMPLAINT STENTS ARE UNKNOWN, A REVIEW OF THE RELEVANT MANUFACTURING RECORDS CANNOT BE CONDUCTED. HOWEVER, PRIOR TO DISTRIBUTION EVO DUODENAL DEVICES ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL CHECKS TO ENSURE DEVICE INTEGRITY. THESE INSPECTIONS AND FUNCTIONAL CHECKS ARE OUTLINED IN INTERNAL PROCEDURES IN PLACE AT CIRL. AS THE EVO DUODENAL DEVICES FROM UNKNOWN LOT NUMBER, A REVIEW OF THE RELEVANT MANUFACTURING RECORDS CANNOT BE CONDUCTED. THERE IS NO EVIDENCE TO SUGGEST THAT THE CUSTOMER DID NOT FOLLOW THE INSTRUCTIONS FOR USE. ROOT CAUSE REVIEW: A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED FROM THE AVAILABLE INFORMATION. A POSSIBLE ROOT CAUSE COULD BE ATTRIBUTED THE PATIENT¿S PRE-EXISTING CONDITION. FROM THE INFORMATION PROVIDED IT IS KNOWN THAT THE PATIENT HAD SYMPTOMATIC MALIGNANT GASTRODUODENAL OUTLET OBSTRUCTION. SUMMARY: COMPLAINT IS CONFIRMED BASED ON THE CUSTOMERS TESTIMONY. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.

    Description of Event or Problem · 0

    SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    510(K) NUMBER: K163468. THE INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.

    Description of Event or Problem · 1

    RATONE ET AL 2020 ¿OUTCOMES OF DUODENAL STENTING: EXPERIENCE IN A (B)(6) TERTIARY CENTER WITH 220 CASES¿. A RETROSPECTIVE SINGLE-CENTER STUDY WAS PERFORMED USING DATA COLLECTED FROM ALL PATIENTS WHO RECEIVED PALLIATIVE DUODENAL SEMSS BETWEEN (B)(6) 2011 AND (B)(6) 2016. A 0.035-INCH GUIDEWIRE (JAG-WIRE BOSTON SCIENTIFICTM, (B)(4) USA) WAS USED TO TRAVERSE THE STRICTURE UNDER FLUOROSCOPIC GUIDANCE, AND THE STENT WAS THEN POSITIONED ACROSS THE STRICTURE AND DEPLOYED. THE LENGTH AND NUMBER OF SEMSS WERE SELECTED BY THE ENDOSCOPIST DURING THE PROCEDURE. ALL STENTS WERE UNCOVERED. THE FOLLOWING UNCOVERED SEMSS WERE USED DURING THE FIVE YEARS OF THE STUDY: COOK EVOLUTIONTM (COOK (B)(4)) 9 AND 12. 187 COOK EVOLUTIONTM DEVICES USED. FOUR PATIENTS (2%) PRESENTED A COMPLICATION RELATED TO SEMS PLACEMENT. THESE COMPLICATIONS INCLUDED INFECTIOUS PNEUMONIA IN ONE PATIENT. THE PATIENT WITH INFECTIOUS PNEUMONIA WAS SUCCESSFULLY TREATED WITH ANTIBIOTIC THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    213785 EVOLUTION DUODENAL CONTROLLED-RELEASE STENT - UNCOVERED MUM STENT, METALIC EXPANDABLE, DUODENAL MUM COOK IRELAND LTD UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention