BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOLUTION COLONIC CONTROLLED-RELEASE STENT - UNCOVERED

    MDR report key: 9564615 · Received January 8, 2020

    Report

    Report Number
    3001845648-2020-00018
    Event Type
    Injury
    Date Received
    January 8, 2020
    Date of Event
    April 22, 2018
    Report Date
    April 17, 2020
    Manufacturer
    COOK IRELAND LTD
    Product Code
    MQR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PMA/510(K)#: K163468. DEVICE EVALUATION: THE EVO STENTS OF UNKNOWN LOT NUMBER WERE NOT RETURNED TO COOK IRELAND FOR EVALUATION. WITH THE INFORMATION PROVIDED, DOCUMENT BASED INVESTIGATION WAS CONDUCTED. THIS FILE WAS CREATED FROM THE ATTACHED JOURNAL ARTICLE TO ADDRESS 2 CASES STENT RESTENOSIS REQUIRING SECOND STENT PLACEMENT WITH COLORECTAL STENT. DOCUMENTS REVIEW INCLUDING IFU REVIEW: AS THE EVO DEVICES FROM UNKNOWN LOT NUMBER, A REVIEW OF THE RELEVANT MANUFACTURING RECORDS CANNOT BE CONDUCTED. PRIOR TO DISTRIBUTION ALL EVO (EVOLUTION COLONIC STENT ) DEVICES ARE SUBJECT TO VISUAL INSPECTION AND FUNCTIONAL CHECKS TO ENSURE DEVICE INTEGRITY. THESE INSPECTIONS AND FUNCTIONAL CHECKS ARE OUTLINED IN INTERNAL PROCEDURES IN PLACE AT CIRL. THE INSTRUCTIONS FOR USE IFU0052-10 (EVOLUTION COLONIC STENT) WHICH INFORMS THE USER ABOUT THE POTENTIAL COMPLICATIONS "ADDITIONAL COMPLICATIONS INCLUDE, BUT ARE NOT LIMITED TO : PERFORATION, HEMORRHAGE, FEVER, INFECTION, ALLERGIC REACTION TO MEDICATION, HYPOTENSION, RESPIRATORY DEPRESSION OR ARREST, CARDIAC ARRHYTHMIA OR ARREST. ADDITIONAL COMPLICATIONS INCLUDE BUT ARE NOT LIMITED TO: INTESTINAL PERFORATION, PAIN, INADEQUATE STENT EXPANSION, STENT MISPLACEMENT AND/OR MIGRATION, TUMOR 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. ROOT CAUSE REVIEW: A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED DUE TO LIMITED INFORMATION PROVIDED IN THIS LITERATURE. A POSSIBLE ROOT CAUSE COULD BE ATTRIBUTED TO PATIENT CONDITION RELATED, AS PER INSTRUCTIONS FOR USE, TUMOR INGROWTH OR OVERGROWTH, STENT OCCLUSION, ARE LISTED AS A POTENTIAL COMPLICATIONS FOLLOWING THE PLACEMENT OF THIS DEVICE. SUMMARY: CUSTOMER COMPLAINT IS CONFIRMED BASED ON CUSTOMER TESTIMONY. THE PATIENT WAS REQUIRING SECOND STENT PLACEMENT. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS. - ATTACHMENT: [PAIS CUNHA ET AL 2018. PDF].

    Description of Event or Problem · 0

    AS PER SOURCE DOC: LITERATURE REVIEW TITLE: ''ENDOSCOPIC STENTING FOR PALLIATION OF INTRA-ABDOMINAL GASTROINTESTINAL MALIGNANT OBSTRUCTION: PREDICTIVE FACTORS FOR CLINICAL SUCCESS'' PAIS-CUNHA ET AL 2018. AS PER LIT REVIEW THIS STUDY AIMED TO ANALYSE THE FACTORS PREDICTING THE EFFECTIVENESS OF STENT PLACEMENT IN PATIENTS WITH GASTROINTESTINAL OBSTRUCTION. IT WAS A RETROSPECTIVE STUDY THAT WAS CARRIED OUT INCLUDING 160 PATIENTS WHO UNDERWENT PALLIATIVE STENTING FOR INTRA-ABDOMINAL OBSTRUCTION, TECHNICAL AND CLINICAL SUCCESS, STENT DYSFUNCTION AND ADVERSE EVENTS WERE ANALYSED. ''WE CARRIED OUT A RETROSPECTIVE STUDY OF A CONSECUTIVE SERIES OF PATIENTS UNDERGOING EITHER GASTRODUODENAL OR COLORECTAL STENT PLACEMENT FOR THE TREATMENT OF MALIGNANT INTRA-ABDOMINAL GASTRODUODENAL OR COLONIC OBSTRUCTION IN A TERTIARY-CARE MEDICAL CENTRE (INSTITUTO PORTUGUÊS DE ONCOLOGIA DO PORTO FRANCISCO GENTIL, E.P.E) BETWEEN (B)(6)2012 AND (B)(6) 2017.'' 'IN TOTAL, 160 PATIENTS HAD A PALLIATIVE INDICATION FOR STENT PLACEMENT AND WERE CONSIDERED FOR ANALYSIS' STENT DYSFUNCTION OCCURRED IN 21 (13%) PATIENTS, SEVEN (15%) PATIENTS WHO HAD UNDERGONE COLORECTAL STENT PLACEMENT AND 14 (13%) PATIENTS WHO HAD UNDERGONE GASTRODUODENAL STENT PLACEMENT (P = 0.731). MIGRATION WAS ASSOCIATED WITH SHORT 6 CM STENTS (9 VS. 2% P = 0.044). OF THE 14 PATIENTS WITH STENT RESTENOSIS, 11 PATIENTS HAD TO RECEIVE A SECOND STENT: 2 COLORECTAL STENTS.

    Additional Manufacturer Narrative · 1

    K163468 - 510 K # - (EXACT RPN KNOWN BUT ALL EVO C STENTS APPROVED UNDER THIS NUMBER.). CANNOT BE CONFIRMED THAT EVO C STENT WAS RELATED TO THIS ADVERSE EVENT. THIS IS A CONSERVATIVE ASSESSMENT INVESTIGATION IS STILL PENDING. A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.

    Description of Event or Problem · 1

    AS PER SOURCE DOC: LITERATURE REVIEW TITLE: ''ENDOSCOPIC STENTING FOR PALLIATION OF INTRA-ABDOMINAL GASTROINTESTINAL MALIGNANT OBSTRUCTION: PREDICTIVE FACTORS FOR CLINICAL SUCCESS'' PAIS-CUNHA ET AL 2018. AS PER LIT REVIEW THIS STUDY AIMED TO ANALYSE THE FACTORS PREDICTING THE EFFECTIVENESS OF STENT PLACEMENT IN PATIENTS WITH GASTROINTESTINAL OBSTRUCTION. IT WAS A RETROSPECTIVE STUDY THAT WAS CARRIED OUT INCLUDING 160 PATIENTS WHO UNDERWENT PALLIATIVE STENTING FOR INTRA-ABDOMINAL OBSTRUCTION, TECHNICAL AND CLINICAL SUCCESS, STENT DYSFUNCTION AND ADVERSE EVENTS WERE ANALYSED. ''WE CARRIED OUT A RETROSPECTIVE STUDY OF A CONSECUTIVE SERIES OF PATIENTS UNDERGOING EITHER GASTRODUODENAL OR COLORECTAL STENT PLACEMENT FOR THE TREATMENT OF MALIGNANT INTRA-ABDOMINAL GASTRODUODENAL OR COLONIC OBSTRUCTION IN A TERTIARY-CARE MEDICAL CENTRE (INSTITUTO PORTUGUÊS DE ONCOLOGIA DO PORTO FRANCISCO GENTIL, E.P.E) BETWEEN DECEMBER 2012 AND JULY 2017.'' 'IN TOTAL, 160 PATIENTS HAD A PALLIATIVE INDICATION FOR STENT PLACEMENT AND WERE CONSIDERED FOR ANALYSIS'. STENT DYSFUNCTION OCCURRED IN 21 (13%) PATIENTS, SEVEN (15%) PATIENTS WHO HAD UNDERGONE COLORECTAL STENT PLACEMENT AND 14 (13%) PATIENTS WHO HAD UNDERGONE GASTRODUODENAL STENT PLACEMENT (P = 0.731). MIGRATION WAS ASSOCIATED WITH SHORT 6 CM STENTS (9 VS. 2% P = 0.044). OF THE 14 PATIENTS WITH STENT RESTENOSIS, 11 PATIENTS HAD TO RECEIVE A SECOND STENT: 2 COLORECTAL STENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    26075 EVOLUTION COLONIC CONTROLLED-RELEASE STENT - UNCOVERED MQR STENT, COLONIC METALLIC EXPANDABLE MQR COOK IRELAND LTD UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention