BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOLUTION® DUODENAL CONTROLLED-RELEASE STENT - UNCOVERED

    MDR report key: 11314115 · Received February 11, 2021

    Report

    Report Number
    3001845648-2021-00094
    Event Type
    Injury
    Date Received
    February 11, 2021
    Report Date
    March 7, 2022
    Manufacturer
    COOK IRELAND LTD
    Product Code
    MUM
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    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. THIS FILE WAS CREATED FROM THE JOURNAL ARTICLE " JANG ET AL 2019 " COMPLAINT FILES (B)(4) (3001845648-2021-00091), (B)(4) (3001845648-2021-00092), (B)(4) (3001845648-2021-00093) AND (B)(4) (3001845648-2021-00094) WERE OPENED AS A RESULT OF THIS PAPER. THIS FILE (B)(4) (3001845648-2021-00094) WAS OPENED TO INVESTIGATE REINTERVENTION FOR THE RECURRENCE OF LUMINAL OBSTRUCTION. 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. AS THE EVO DUODENAL DEVICES FROM UNKNOWN LOT NUMBER, A REVIEW OF THE RELEVANT MANUFACTURING RECORDS CANNOT BE CONDUCTED. AS PER THE INSTRUCTIONS FOR USE, IFU0053-10, WHICH ACCOMPANIES THIS DEVICE IT INFORMS THE USER ABOUT THE POTENTIAL COMPLICATIONS ¿ADDITIONAL COMPLICATIONS INCLUDE, BUT ARE NOT LIMITED TO: STENT MISPLACEMENT AND/OR MIGRATION, STENT OCCLUSION¿. 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 TO PATIENT CONDITION RELATED, AS PER INSTRUCTIONS FOR USE, STENT OCCLUSION IS LISTED AS A COMPLICATION FOLLOWING THE USE OF THIS DEVICE. FROM THE INFORMATION PROVIDED IT IS KNOWN THAT THE PATIENT HAD MALIGNANT GASTRIC OUTLET OBSTRUCTION. SUMMARY: COMPLAINT IS CONFIRMED BASED ON THE CUSTOMERS TESTIMONY. AS PER MEDICAL ADVISOR OPINION. REQUIRE INTERVENTION/ADDITIONAL PROCEDURES S=4. PROCEDURE RELATED COMPLICATION. IT IS COVERED IN IFU BY STENT OCCLUSION. 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

    JANG ET AL 2019 ¿SUPERIORITY OF GASTROJEJUNOSTOMY OVER ENDOSCOPIC STENTING FOR PALLIATION OF MALIGNANT GASTRIC OUTLET OBSTRUCTION. A RETROSPECTIVE COHORT STUDY WAS CONDUCTED FROM THE REGISTRIES OF PATIENTS WHO RECEIVED ENDOSCOPIC DUODENAL SEMS PLACEMENT ANDWHO UNDERWENT GJ FOR THE PALLIATION OF MALIGNANT GOO AT THE (B)(6) CLINIC BETWEEN 2011 AND 2017. FOR ENDOSCOPIC STENTING, UNCOVERED, DUODENAL SEMS, EITHER WALLFLEX DUODENAL STENT (BOSTON SCIENTIFIC, (B)(4)) OR EVOLUTION DUODENAL STENT (COOK MEDICAL, (B)(4)), WAS PLACED UNDER ENDOSCOPIC AND FLUOROSCOPIC GUIDANCE. 183 PATIENTS WITH ENTERAL STENTING AND 127 WITH GJ WERE INCLUDED IN THE STUDY. THE RATES OF REINTERVENTION FOR THE RECURRENCE OF LUMINAL OBSTRUCTION WERE SIMILAR BETWEEN THE 2 GROUPS: 23.1% IN ENTERAL STENTING GROUP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    209651 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 Female Required Intervention