BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOLUTION® COLONIC CONTROLLED-RELEASE STENT - UNCOVERED

    MDR report key: 18443460 · Received January 4, 2024

    Report

    Report Number
    3001845648-2024-00002
    Event Type
    Injury
    Date Received
    January 4, 2024
    Date of Event
    April 12, 2016
    Report Date
    May 21, 2024
    Manufacturer
    COOK IRELAND LTD
    Product Code
    MQR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER
    Health Professional
    N

    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 01X EVOLUTION® COLONIC CONTROLLED-RELEASE STENT - UNCOVERED DEVICES OF UNKNOWN RPN AND LOT NUMBERS INVOLVED IN THIS COMPLAINT WERE NOT AVAILABLE FOR EVALUATION. WITH THE INFORMATION PROVIDED, A DOCUMENT-BASED INVESTIGATION WAS CONDUCTED. THIS FILE WAS CREATED IN RESPONSE TO THE JOURNAL ARTICLE ¿AMELUNG 2016 - DEVIATING COLOSTOMY CONSTRUCTION VERSUS STENT PLACEMENT AS BRIDGE TO SURGERY FOR MALIGNANT LEFT-SIDED COLONIC OBSTRUCTION¿ TO CAPTURE 01X CASE OF STENT OBSTRUCTION CAUSED BY FECAL DEBRIS. THE FOLLOWING WERE ALSO RAISED IN RESPONSE TO THIS JOURNAL ARTICLE: ¿ PR (B)(4) ¿ ¿AMELUNG 2016 - PERFORATION¿ ¿ PR (B)(4) ¿ ¿AMELUNG 2016 ¿ STENT MIGRATION¿ THE DEVICE LAB EVALUATION COULD NOT BE COMPLETED AS THE DEVICE, OR PHOTOGRAPHIC EVIDENCE OF THE DEVICE, WAS NOT RETURNED FOR EVALUATION. AN ADVERSE EVENT HAS BEEN REPORTED WITHOUT A DEVICE PROBLEM. A DEVICE MALFUNCTION WAS NOT REPORTED. TRENDING WILL MONITOR IF ANY FUTURE INVESTIGATION IS REQUIRED. MANUFACTURING RECORDS 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. INSTRUCTIONS FOR USE AND/LABEL REVIEW: AS PER THE IFU (IFU0052), STENT OCCLUSION IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH GI ENDOSCOPY ¿THOSE ASSOCIATED WITH GI ENDOSCOPY INCLUDE, BUT ARE NOT LIMITED TO: PERFORATION, HEMORRHAGE, FEVER, INFECTION, ALLERGIC REACTION TO MEDICATION, HYPOTENSION, RESPIRATORY DEPRESSION OR ARREST, CARDIAC ARRHYTHMIA OR ARREST.¿ ¿ADDITIONAL ADVERSE EVENTS INCLUDE, BUT ARE NOT LIMITED TO: INTESTINAL PERFORATION, PAIN, INADEQUATE STENT EXPANSION, STENT MISPLACEMENT AND/OR MIGRATION, TUMOUR INGROWTH OR OVERGROWTH, STENT OCCLUSION, ULCERATIONS, PRESSURE NECROSIS, EROSION OF THE LUMINAL MUCOSA, SEPTICEMIA, FOREIGN BODY SENSATION, BOWEL IMPACTION, DIARRHEA, CONSTIPATION, PERITONITIS, SYMPTOMS OF TENESMUS OR URGENCY/INCONTINENCE, DEATH (OTHER THAN DUE TO NORMAL DISEASE PROGRESSION).¿ THERE IS NO EVIDENCE TO SUGGEST THAT THE CUSTOMER DID NOT FOLLOW THE INSTRUCTIONS FOR USE OR PRODUCT LABEL. IMAGE REVIEW: AN IMAGE WAS NOT RETURNED FOR EVALUATION. ROOT CAUSE ANALYSIS: A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED FROM THE AVAILABLE INFORMATION. A POSSIBLE ROOT CAUSE COULD BE ATTRIBUTED TO PRE-EXISTING PATIENT CONDITIONS AND/OR PROCEDURAL ADVERSE EVENT. AS PER THE IFU, STENT OCCLUSION IS A KNOWN ADVERSE EVENT ASSOCIATED WITH GI ENDOSCOPY. AS PER MEDICAL ADVISOR INPUT, THE STENT OCCLUSION COULD ALSO HAVE BEEN CAUSED BY THE STENT AND/OR PATIENT PRE-EXISTING CONDITIONS. CONFIRMATION OF COMPLAINT: COMPLAINT IS CONFIRMED BASED ON CUSTOMER AND/OR REP TESTIMONY. CONFIRMED QUANTITY OF 01X USED DEVICES. SUMMARY OF INVESTIGATION: ACCORDING TO THE JOURNAL ARTICLE, THE PATIENT DID EXPERIENCE ADVERSE EFFECTS DUE TO THIS OCCURRENCE. THE PATIENT EXPERIENCED STENT OBSTRUCTION CAUSED BY FECAL DEBRIS. ALL PATIENTS HAD TO UNDERGO AN EMERGENCY RESECTION AS A RESULT. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.

    Description of Event or Problem · 0

    AMELUNG, 2016 ¿ DEVIATING COLOSTOMY CONSTRUCTION VERSUS STENT PLACEMENT AS BRIDGE TO SURGERY FOR MALIGNANT LEFT-SIDED COLONIC OBSTRUCTION. ALL PATIENTS UNDERWENT THE INITIAL DECOMPRESSION PROCEDURE WITHIN 48 H AFTER PRESENTATION WITH OBSTRUCTIVE SYMPTOMS. THE GASTROINTESTINAL SURGEON ON CALL PERFORMED THE COLOSTOMY CONSTRUCTIONS, WHILE SEMS PLACEMENT WAS PERFORMED BY ONE OF THREE EXPERT ENDOSCOPISTS WITH A MINIMUM OF 4-YEAR EXPERIENCE ([20 PROCEDURES) WITH COLONIC STENT PLACEMENT. COLOSTOMIES WERE CONSTRUCTED ON THE RIGHT TRANSVERSE COLON. AN INCISION WAS MADE IN THE RIGHT UPPER ABDOMINAL QUADRANT; THE TRANSVERSE COLON WAS ELEVATED TO THE SKIN, TEMPORARILY ANCHORED WITH A PLASTIC ROD AND FIXED WITH RESOLVABLE STITCHES. FOUR DIFFERENT STENT TYPES WERE USED, BASED ON AVAILABILITY, I.E., WALLSTENT _ (BOSTON SCIENTIFIC, NATRICK, MA, USA), WALLFLEX_ (BOSTON SCIENTIFIC), ULTRAFLEX_ (BOSTON SCIENTIFIC) AND EVOLUTION_ (COOK MEDICAL, LIMERICK, IRELAND). AFTER COLOSTOMY CONSTRUCTION OR STENT PLACEMENT, PATIENTS RECEIVED ENTERAL FEEDING AS SOON AS POSSIBLE. ELECTIVE RESECTION WAS PERFORMED AFTER APPROXIMATELY 2¿4 WEEKS. SIX PATIENTS WITH TECHNICALLY SUCCESSFUL STENT PLACEMENT DID NOT HAVE ANY RELIEF OF SYMPTOMS, DUE TO: STENT OBSTRUCTION CAUSED BY FECAL DEBRIS (N = 1). PATIENT OUTCOME: REQUIRE INTERVENTION/ADDITIONAL PROCEDURES S=4. PATIENT/EVENT INFO - NOTES: AS PER FDA GUIDANCE: AVERAGE PATIENT AGE AND WEIGHT, AS WELL AS THE GENDER OF THE MAJORITY OF PATIENTS INVOLVED/INDIVIDUAL PATIENT INFO IF AVAILABLE.

    Description of Event or Problem · 0

    SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION ON 21-MAY-2024.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1502012 EVOLUTION® COLONIC CONTROLLED-RELEASE STENT - UNCOVERED MQR STENT, COLONIC METALLIC EXPANDABLE MQR COOK IRELAND LTD UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Female Required Intervention