BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOLUTION® COLONIC CONTROLLED-RELEASE STENT - UNCOVERED

    MDR report key: 18442510 · Received January 4, 2024

    Report

    Report Number
    3001845648-2024-00011
    Event Type
    Injury
    Date Received
    January 4, 2024
    Date of Event
    November 5, 2016
    Report Date
    May 23, 2024
    Manufacturer
    COOK IRELAND LTD
    Product Code
    MQR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PMA 510K #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 16X 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 ¿ABBAS 2016 - PREDICTORS OF OUTCOME FOR ENDOSCOPIC COLORECTAL STENTING: A DECADE EXPERIENCE¿ TO CAPTURE ¿16X OBSTRUCTIONS REQUIRING INTERVENTION¿. THE FOLLOWING WERE ALSO RAISED IN RESPONSE TO THIS JOURNAL ARTICLE: ¿ 417517 - ABBAS 2016 PERFORATION. ¿ 417518 - ABBAS 2016 FAILURE OF STENT EXPANSION. 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. HISTORICAL DATA REVIEW: HISTORICAL DATA WAS NOT REVIEWED 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. 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 PATIENT PRE-EXISTING CONDITIONS. CONFIRMATION OF COMPLAINT: COMPLAINT IS CONFIRMED BASED ON CUSTOMER AND/OR REP TESTIMONY. CONFIRMED QUANTITY OF 16X USED DEVICES. SUMMARY OF INVESTIGATION: ACCORDING TO THE JOURNAL ARTICLE, THE PATIENT DID EXPERIENCE ADVERSE EFFECTS DUE TO THIS OCCURRENCE. THE PATIENT EXPERIENCED A RECURRENCE OF SYMPTOMS AS A RESULT. AS PER CLINICAL INPUT AND THE JOURNAL ARTICLE, SURGICAL INTERVENTION WOULD HAVE BEEN PERFORMED IN ORDER TO TREAT THE OCCLUDED STENTS. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.

    Description of Event or Problem · 0

    ABBAS, 2016 ¿ PREDICTORS OF OUTCOME FOR ENDOSCOPIC COLORECTAL STENTING: A DECADE EXPERIENCE. A RETROSPECTIVE REVIEW WAS CONDUCTED OF ALL ENDOSCOPIC STENTING PROCEDURES PERFORMED BY A COLORECTAL SURGEON AT A TERTIARY REFERRAL INSTITUTION BETWEEN 2003 AND 2013. MAIN OUTCOME MEASURES INCLUDED TECHNICAL SUCCESS, CLINICAL SUCCESS, COMPLICATIONS, AND PREDICTORS OF OUTCOME. 16 CASES OF OBSTRUCTION REQUIRING INTERVENTION.

    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
    559977 EVOLUTION® COLONIC CONTROLLED-RELEASE STENT - UNCOVERED MQR STENT, COLONIC METALLIC EXPANDABLE MQR COOK IRELAND LTD UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Male Required Intervention