BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOLUTION® COLONIC CONTROLLED-RELEASE STENT - UNCOVERED

    MDR report key: 18453212 · Received January 5, 2024

    Report

    Report Number
    3001845648-2024-00019
    Event Type
    Injury
    Date Received
    January 5, 2024
    Date of Event
    April 16, 2014
    Report Date
    May 23, 2024
    Manufacturer
    COOK IRELAND LTD
    Product Code
    MQR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    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 07X EVOLUTION® COLONIC CONTROLLED-RELEASE STENT - UNCOVERED DEVICE 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 ¿BRIDGE-TO-SURGERY STENT PLACEMENT VERSUS EMERGENCY SURGERY FOR ACUTE MALIGNANT COLONIC OBSTRUCTION¿ TO CAPTURE 01X CASE OF PERFORATION, 03X CASE OF TUMOUR INGROWTH/OVERGROWTH, AND 03X CASES OF FECAL IMPACTION. THE FOLLOWING WERE ALSO RAISED IN RESPONSE TO THIS ARTICLE: ¿ (B)(4): VAN DEN BERG 2014 - 2 CASES INSUFFICIENT DEPLOYMENT OF THE SEMS, ¿ (B)(4)*: VAN DEN BERG 2014 ¿ 3 CASES INABILITY TO PASS THE GUIDEWIRE ACROSS THE STRICTURE, ¿ (B)(4)*: VAN DEN BERG 2014 ¿ ONE PATIENT DEATH FROM A STENT-RELATED PERFORATION, ¿ (B)(4): VAN DEN BERG 2014 ¿ 2 CASES STENT MIGRATION *NOTE: PR¿S (B)(4) WERE CANCELLED DUE TO CLINICAL INPUT BEING RECEIVED THAT DETERMINED THAT THE COOK DEVICE USED IN THIS STUDY DID NOT CONTRIBUTE TO EITHER COMPLAINT. THE DEVICE LAB EVALUATION COULD NOT BE COMPLETED AS THE DEVICE, OR PHOTOGRAPHIC EVIDENCE OF THE DEVICE, WAS NOT RETURNED FOR EVALUATION. 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), INTESTINAL PERFORATION, STENT INGROWTH OR OVERGROWTH, AND BOWEL IMPACTION ARE 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 KNOWN POTENTIAL ADVERSE EVENTS ASSOCIATED WITH THE GI ENDOSCOPY PROCEDURE, THE COOK DEVICE ITSELF, AS WELL AS PATIENTS PRE-EXISTING CONDITIONS. AS STATED ABOVE, PERFORATION, BOWEL IMPACTION AND TUMOUR INGROWTH OR OVERGROWTH ARE KNOWN ADVERSE EVENTS THAT ARE CAPTURED IN THE INSTRUCTIONS FOR USE¿S ¿POTENTIAL ADVERSE EVENTS¿ SECTION. AS PER CLINICAL INPUT, THE PERFORATION AND BOWEL IMPACTION WERE LIKELY CAUSED BY THE COLONIC DEVICE ITSELF WHILE THE TUMOUR INGROWTH AND OVERGROWTH WAS CAUSED BY THE PATIENT'S PRE-EXISTING CONDITIONS. CONFIRMATION OF COMPLAINT: COMPLAINT IS CONFIRMED BASED ON CUSTOMER AND/OR REP TESTIMONY. CONFIRMED QUANTITY OF 07X USED DEVICES. SUMMARY OF INVESTIGATION: ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID/DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. AS PER THE MEDICAL ADVISOR, INTERVENTION/ADDITIONAL PROCEDURES WOULD BE REQUIRED TO TREAT THESE ADVERSE EVENTS. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR SIMILAR EVENTS.

    Description of Event or Problem · 0

    VAN DEN BERG, 2014 ¿ BRIDGE-TO-SURGERY STENT PLACEMENT VERSUS EMERGENCY SURGERY FOR ACUTE MALIGNANT COLONIC OBSTRUCTION PROCEDURE: THE FOLLOWING SURGICAL APPROACHES WERE USED IN THE SURGERY-ALONE GROUP AND FOR PATIENTS IN THE SEMS GROUP IN WHOM ACUTE OPERATION WAS WARRANTED (FOR EXAMPLE IN THE EVENT OF TECHNICAL FAILURE): RESECTION WITH PRIMARY ANASTOMOSIS WITH OR WITHOUT DIVERTING STOMA, RESECTION WITH DEFINITIVE STOMA, DECOMPRESSION STOMA AIMING AT RESECTION IN AN ELECTIVE SETTING, OR DEFINITIVE STOMA CREATION WITHOUT RESECTION. FOLLOWING SEMS PLACEMENT OR STOMA FORMATION AS A BRIDGE TO ELECTIVE SURGERY, SUBSEQUENT ELECTIVE SURGERY ENTAILED RESECTION WITH PRIMARY ANASTOMOSIS. RESECTION INCLUDED A ROUTINE MESOCOLIC LYMPHADENECTOMY, WITH QUALITY ASSESSMENT USING A CUT-OFF OF A MEDIAN OF 12 EXAMINED LYMPH NODES, ACCORDING TO PUBLISHED GUIDELINES 21,22. PATIENTS WITH RESECTABLE SYNCHRONOUS LIVER METASTASIS UNDERWENT COLECTOMY FOLLOWED BY CURATIVE METASTASECTOMY IN ANOTHER OPERATION. THERE WAS NO STRICT SURGICAL PROTOCOL IN THE TWO HOSPITALS FOR EMERGENCY SURGERY. THE CHOICE OF SPECIFIC SURGICAL TREATMENT WAS AT THE DISCRETION OF THE CONSULTING SURGEON DEPENDING ON PREOPERATIVE AND INTRAOPERATIVE FINDINGS, TUMOUR LOCATION AND PATIENT CONDITION. ALL ELECTIVE OPERATIONS WERE PERFORMED BY DEDICATED COLORECTAL SURGEONS, WHEREAS EMERGENCY SURGERY WAS UNDERTAKEN BY THE SURGEON ON CALL. MULTIPLE AE¿S AS PER TABLE 5: 1 OTHER STENT PERFORATION 3 CASES STENT INGROWTH / OVERGROWTH. 3 CASES FAECAL IMPACTION UNCONFIRMED IF RELATED TO COOK STENT AS MULTIPLE DEVICES USED IN STUDY.

    Description of Event or Problem · 0

    SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION ON 23-MAY-2024.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1575020 EVOLUTION® COLONIC CONTROLLED-RELEASE STENT - UNCOVERED MQR STENT, COLONIC METALLIC EXPANDABLE MQR COOK IRELAND LTD UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Male Required Intervention