BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOLUTION® DUODENAL CONTROLLED-RELEASE STENT - UNCOVERED

    MDR report key: 11306822 · Received February 10, 2021

    Report

    Report Number
    3001845648-2021-00080
    Event Type
    Injury
    Date Received
    February 10, 2021
    Report Date
    February 16, 2022
    Manufacturer
    COOK IRELAND LTD
    Product Code
    MUM
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PMA/510(K) #: 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) (3001845648-2021-00078), (B)(4) (3001845648-2021-00079), (B)(4) (3001845648-2021-00080) AND (B)(4) (3001845648-2021-00081) WERE OPENED AS A RESULT OF THIS PAPER. THIS FILE (B)(4) (3001845648-2021-00080) WAS OPENED TO INVESTIGATE PERFORATION. 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: INTESTINAL PERFORATION¿. 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. AS PER INSTRUCTIONS FOR USE, INTESTINAL PERFORATION IS LISTED AS A COMPLICATION FOLLOWING THE USE OF THIS DEVICE. SUMMARY: COMPLAINT IS CONFIRMED BASED ON THE CUSTOMERS TESTIMONY. AS PER MEDICAL ADVISOR OPINION PATIENTS REQUIRED INTERVENTION/ADDITIONAL PROCEDURES. (REF. ATT. KUROKI CLINICAL INPUT) 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

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

    Description of Event or Problem · 1

    KUROKI ET AL 2018 (EVO-D) ¿ ¿EFFICACY AND SAFETY OF ENDOSCOPIC DUODENAL STENTING: A RETROSPECTIVE CLINICAL STUDY¿. GOO WAS CAUSED BY GASTRIC CANCER IN 11 PATIENTS (28%), PANCREATIC CANCER IN 22 (56%), CHOLANGIOCARCINOMA IN 2 (5%), GALL BLADDER CANCER IN 3 (8%), AND COLON CANCER IN 1 (3). TWELVE STENTS (31%) WERE MAINLY LOCATED IN STOMACH, 3 (8%) WERE IN 1ST PART OF DUODENUM, 12 (31%) WERE IN 2ND PART, 11 (28%) WERE IN 3RD PART, AND 1 (3%) WAS MORE DISTAL. THE MEAN LENGTH OF STENOSIS WAS 42 ± 22 MM. WE USED WALLFLEX STENT IN 23 PATIENTS (59%), NITI-S STENT IN 12 (31%), AND EVOLUTION STENT IN 4 (10%). 1 PERFORATION AFTER SEMS PLACEMENT REQUIRING STARVATION CURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    204432 EVOLUTION® DUODENAL CONTROLLED-RELEASE STENT - UNCOVERED MUM STENT, METALIC EXPANDABLE, DUODENAL MUM COOK IRELAND LTD UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention