BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVOLUTION® DUODENAL CONTROLLED-RELEASE STENT - UNCOVERED

    MDR report key: 16379263 · Received February 15, 2023

    Report

    Report Number
    3001845648-2023-00108
    Event Type
    Malfunction
    Date Received
    February 15, 2023
    Report Date
    March 9, 2023
    Manufacturer
    COOK IRELAND LTD
    Product Code
    MUM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PMA/510(K) # 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 1X EVO-22-27-6-D DEVICE OF UNKNOWN LOT NUMBER INVOLVED IN THIS COMPLAINT WAS IMPLANTED IN THE PATIENT AND WAS NOT AVAILABLE FOR EVALUATION. WITH THE INFORMATION PROVIDED, A DOCUMENT-BASED INVESTIGATION WAS CONDUCTED. THIS FILE WAS CREATED FROM THE ATTACHED JOURNAL ARTICLE TO CAPTURE 'USER ERROR ¿ STENT REMOVAL' LAB EVALUATION: THE DEVICE LAB EVALUATION COULD NOT BE COMPLETED AS THE DEVICE, OR PHOTOGRAPHIC EVIDENCE OF THE DEVICE, WAS NOT RETURNED FOR EVALUATION. DOCUMENT REVIEW: PRIOR TO DISTRIBUTION ALL 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. IFU & LABEL REVIEW: IT WAS NOTED IN THE JOURNAL ARTICLE THAT THE EVO-22-27-6-D DEVICE WAS REMOVED ENDOSCOPICALLY FROM THE PATIENT 10 WEEKS POST-SEMS PLACEMENT. AS PER THE JOURNAL ARTICLE ¿ABOUT 10 WEEKS POST STENT INSERTION, PATIENT REGAINED HER BASELINE WEIGHT AND DESIRED REMOVAL OF STENT. SURGICAL OPTION WAS GIVEN TO THE PATIENT BUT SHE OPTED FOR ENDOSCOPIC ATTEMPT AT REMOVAL OF STENT. EGD PERFORMED UNDER GENERAL ANAESTHESIA/ INTUBATION AND USING CARBON DIOXIDE (CO2) FOR INSUFFLATION SHOWED DUODENAL MUCOSA EMBEDDING INTO THE STENT. STENT WAS DISLODGED BY GENTLE MANIPULATION WITH THE SCOPE TIP AND A RAT-TOOTH FORCEPS AND THEN SUCCESSFULLY PULLED OUT BY INVERSION AND TRACTION. AS PER THE IFU, THE WARNINGS IN PLACE FOR USE OF THE EVOLUTION DUODENAL STENT SYSTEM ¿ UNCOVERED IS AS FOLLOWS; ¿THE STENT IS NOT INTENDED TO BE REMOVED OR REPOSITIONED AFTER STENT PLACEMENT AND IS INTENDED TO REMAIN IN THE BODY PERMANENTLY. ATTEMPTS TO REMOVE OR REPOSITION STENT AFTER PLACEMENT MAY CAUSE DAMAGE TO SURROUNDING TISSUE OR MUCOSA.¿ AS THE DEVICE WAS REMOVED AFTER STENT PLACEMENT, THERE IS EVIDENCE TO SUGGEST THAT THE USER DID NOT FOLLOW THE INSTRUCTIONS FOR USE . IMAGE REVIEW: AN IMAGE WAS NOT RETURNED FOR EVALUATION. ROOT CAUSE REVIEW: A DEFINITIVE ROOT CAUSE OF USER-ERROR WAS IDENTIFIED FROM THE AVAILABLE INFORMATION. THE DEVICE WAS ENDOSCOPICALLY REMOVED BY THE PHYSICIAN 10 WEEKS POST-SEMS PLACEMENT. THIS IS A CONTRADICTION OF THE WARNINGS SECTION OF THE IFU. SUMMARY: THE COMPLAINT IS CONFIRMED BASED ON CUSTOMER TESTIMONY. ACCORDING TO THE JOURNAL ARTICLE, THERE WAS NO PATIENT OUTCOME OR ADVERSE EVENTS REPORTED. THE MEDICAL ADVISOR ALSO CONFIRMED THERE WERE NO COMPLICATIONS. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.

    Description of Event or Problem · 0

    SANDHU ET AL - UNCOVERED DUODENAL STENT REMOVAL: SHOULD IT BE ATTEMPTED? DUE TO POOR SURGICAL CANDIDACY, PATIENT OPTED FOR PALLIATIVE DUODENAL STENT INSERTION. A REPEAT ESOPHAGOGASTRODUODENOSCOPY (EGD) SHOWED FRIABLE, MALIGNANT APPEARING SEVERE NARROWING AT THE D1/D2 SEGMENT OF DUODENUM. MULTIPLE BIOPSIES WERE TAKEN AND A COOK EVOLUTION UNCOVERED DUODENAL STENT 6 CM X 22 MM WAS PLACED ACROSS THE STRICTURE. BIOPSIES SHOWED NECRO INFLAMMATORY TISSUE. DUE TO HIGH CONCERN FOR MALIGNANCY, A REPEAT EGD WITH MULTIPLE ADDITIONAL BIOPSIES WERE DONE, HOWEVER THE PATHOLOGY REMAINED NON-DIAGNOSTIC FOR MALIGNANCY. ABOUT 10 WEEKS POST STENT INSERTION, PATIENT REGAINED HER BASELINE WEIGHT AND DESIRED REMOVAL OF STENT. SURGICAL OPTION WAS GIVEN TO THE PATIENT BUT SHE OPTED FOR ENDOSCOPIC ATTEMPT AT REMOVAL OF STENT. EGD PERFORMED UNDER GENERAL ANAESTHESIA/ INTUBATION AND USING CARBON DIOXIDE (CO2) FOR INSUFFLATION SHOWED DUODENAL MUCOSA EMBEDDING INTO THE STENT. STENT WAS DISLODGED BY GENTLE MANIPULATION WITH THE SCOPE TIP AND A RAT-TOOTH FORCEPS AND THEN SUCCESSFULLY PULLED OUT BY INVERSION AND TRACTION. A RE-LOOK ENDOSCOPY DID NOT REVEAL EVIDENCE OF PERFORATION. PATIENT WAS ADMITTED OVERNIGHT. A COMPUTED TOMOGRAPHY ABDOMEN DONE SHOWED NO EVIDENCE OF PERFORATION. SUBSEQUENT TO THIS, SHE UNDERWENT DILATION OF THE STRICTURE AND IS DOING WELL 3 MONTHS LATER. AS PER THE INSTRUCTIONS FOR USE, THE STENT IS NOT INTENDED TO BE REMOVED OR REPOSITIONED AFTER STENT PLACEMENT AND IS INTENDED TO REMAIN IN THE BODY PERMANENTLY. THIS FILE WILL CAPTURE THE USER ERROR OF REMOVAL OF AN UNCOVERED EVOLUTION DUODENAL STENT.

    Description of Event or Problem · 0

    SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION ON 09-MAR-2023.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    943692 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 Female