BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOLUTION® BILIARY CONTROLLED-RELEASE STENT - FULLY COVERED

    MDR report key: 17008902 · Received May 26, 2023

    Report

    Report Number
    3001845648-2023-00404
    Event Type
    Injury
    Date Received
    May 26, 2023
    Date of Event
    August 20, 2019
    Report Date
    June 1, 2023
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FGE
    UDI-DI
    10827002231341
    PMA / PMN Number
    K121430
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION IS STILL PENDING, A FOLLOW-UP MDR REPORT WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION THE 1X EVO-FC-10-11-6-B DEVICE OF LOT NUMBER C1599188 INVOLVED IN THIS COMPLAINT WAS NOT AVAILABLE FOR EVALUATION. WITH THE INFORMATION PROVIDED, A DOCUMENT-BASED INVESTIGATION WAS CONDUCTED. THIS FILE WAS CREATED IN RESPONSE TO A PMCF STUDY ¿MDR2052¿ TO CAPTURE ¿OFF LABEL USE AND STENT MIGRATION¿. 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. A REVIEW OF THE MANUFACTURING RECORDS DID NOT REVEAL ANY DISCREPANCIES THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT ISSUE. HISTORICAL DATA REVIEW: THE REVIEW OF RELEVANT MANUFACTURING RECORDS CONFIRMS THE FAILURE MODE HAS NOT PREVIOUSLY OCCURRED FOR THIS WORK ORDER. IFU & LABEL REVIEW: AS PER THE IFU (IFU0062), STENT MIGRATION AND DEATH (OTHER THAN DUE TO NORMAL DISEASE PROGRESSION) ARE KNOWN POTENTIAL ADVERSE EVENTS THAT CAN OCCUR IN CONJUNCTIONS WITH BILIARY STENT PLACEMENT: ¿ADDITIONAL ADVERSE EVENTS THAT CAN OCCUR IN CONJUNCTION WITH BILIARY STENT PLACEMENT INCLUDE, BUT ARE NOT LIMITED TO: ALLERGIC REACTION TO NICKEL, BILE DUCT ULCERATION, DEATH (OTHER THAN DUE TO NORMAL DISEASE PROGRESSION), FEVER, INFLAMMATION, INGROWTH DUE TO TUMOUR OR EXCESSIVE HYPERPLASTIC TISSUE, NAUSEA, OBSTRUCTION OF THE PANCREATIC DUCT, PAIN/DISCOMFORT, PERFORATION, RECURRENT OBSTRUCTIVE JAUNDICE, STENT MIGRATION, STENT MISPLACEMENT, STENT OCCLUSION, TRAUMA TO THE BILIARY TRACT OR DUODENUM, TUMOUR OVERGROWTH, VOMITING¿ AS PER THE INTENDED USE SECTION OF THE IFU (IFU0062), ¿THIS DEVICE IS USED IN PALLIATION OF MALIGNANT NEOPLASMS IN THE BILIARY TREE¿. AS PER THE PMCF STUDY CASEBOOK, IT WAS NOTED THAT THE STENT WAS USED IN THE TREATMENT OF ¿CALCIFIANT CHRONIC PANCREATITIS¿, A BENIGN CONDITION AS PER THE MEDICAL ADVISOR. THE USE OF THIS DEVICE FOR THE TREATMENT OF ¿CALCIFIANT CHRONIC PANCREATITIS¿ IN THIS STUDY WAS OFF-LABEL USE. WITH THE ABOVE INFORMATION, THERE IS EVIDENCE TO SUGGEST THAT THE CUSTOMER DID NOT FOLLOW THE INSTRUCTIONS FOR USE/PRODUCT LABEL. IMAGE REVIEW: AN IMAGE WAS NOT RETURNED FOR EVALUATION. ROOT CAUSE REVIEW: A DEFINITIVE ROOT CAUSE OF OFF-LABEL USE WAS IDENTIFIED FROM THE AVAILABLE INFORMATION. THE STENT WAS USED IN THE TREATMENT OF ¿CALCIFIANT CHRONIC PANCREATITIS¿, A BENIGN CONDITION, WHICH IS DEEMED UNFORESEEN MISUSE OF THE DEVICE AS PER THE IFU¿S INTENDED USE SECTION. AS PER THE IFU, STENT MIGRATION IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH BILIARY STENT PLACEMENT. THE STENT MIGRATION WAS DEEMED LIKELY RELATED TO THE OFF-LABEL USE OF THE DEVICE. AS PER THE PATIENT CASEBOOK THE CAUSE OF PATIENT DEATH IN THE STUDY IS UNKNOWN. IT WAS NOTED IN THE RELATIONSHIP ASSESSMENT SECTION (PAGE 32-33), THAT THE STENT MIGRATION WAS NOT RELATED TO NOT DID IT LEAD TO THE PATIENT DEATH. SUMMARY: ACCORDING TO THE PMCF STUDY, THE EVO-FC-10-11-6-B STENT MIGRATED 40 DAYS POST-STENT PLACEMENT. CONFIRMED QUANTITY OF 1 DEVICE. CONFIRMED USED. AS A RESULT OF THIS OCCURRENCE, THE PATIENT DID EXPERIENCE AN ADVERSE EFFECT DUE TO THIS OCCURRENCE. THE PATIENT REQUIRED ENDOSCOPIC PLACEMENT OF A NEW STENT TO TREAT THE STENT MIGRATION. THE PATIENTS HAD AN UNKNOWN CAUSE OF DEATH, UNRELATED TO THE STUDY DEVICE. INVESTIGATION FINDINGS CONCLUDED A DEFINITIVE ROOT CAUSE OF ¿OFF-LABEL USE¿. THE USE OF THIS DEVICE FOR THE TREATMENT OF ¿CALCIFIANT CHRONIC PANCREATITIS¿ IN THIS STUDY WAS DEEMED OFF-LABEL USE AS THE IFU STATES; ¿THIS DEVICE IS USED IN PALLIATION OF MALIGNANT NEOPLASMS IN THE BILIARY TREE¿. THE STENT MIGRATION WAS DEEMED RELATED TO THE OFF-LABEL USE PLACEMENT. COMPLAINT IS CONFIRMED BASED ON CUSTOMER AND/OR REP TESTIMONY. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.

    Description of Event or Problem · 0

    MDR2052 COOK 204-129_AE1 EVO-FC-11-6-B OFF LABEL USE , DEVICE USED FOR A BENIGN CONDITION, (B)(6) 2019 - 40 DAYS POST PROCEDURE - PARTIAL STENT MIGRATION MANAGED ENDOSCOPICALLY. NEW STUDY STENT PLACED. PATIENT OUTCOME: ENDOSCOPIC TREATMENT, NEW STENT PLACED. DATE OF DEATH - (B)(6) 2020.

    Description of Event or Problem · 0

    SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION ON 01-JUN-2023.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1503165 EVOLUTION® BILIARY CONTROLLED-RELEASE STENT - FULLY COVERED FGE CATHETER, BILIARY, DIAGNOSTIC - BILIARY STENT - METAL FGE COOK IRELAND LTD C1599188 10827002231341

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Male Required Intervention