BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN

    MDR report key: 9472641 · Received December 16, 2019

    Report

    Report Number
    3001845648-2019-00721
    Event Type
    Injury
    Date Received
    December 16, 2019
    Report Date
    August 23, 2022
    Manufacturer
    COOK IRELAND LTD
    Product Code
    ESW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PMA/510(K) #: AS THE RPN IS UNKNOWN, PROVIDING BOTH 510K NUMBERS FOR PARTIALLY AND FULLY COVERED EVOLUTION ESOPHAGEAL DEVICES. K162717 K093619 DEVICE EVALUATION: THE EVO (ESOPHAGEAL METAL) DEVICE OF UNKNOWN LOT NUMBER WAS NOT RETURNED TO COOK IRELAND FOR EVALUATION. WITH THE INFORMATION PROVIDED, DOCUMENT BASED INVESTIGATION WAS CONDUCTED. THIS FILE WAS CREATED FROM THE ATTACHED ARTICLE TO ADDRESS STENT MIGRATION "LATE COMPLICATION WAS NOTED TO BE MIGRATION IN 9 (21.4%) PATIENTS." DOCUMENTS REVIEW INCLUDING IFU REVIEW: AS THE EVO STENT IS UNKNOWN DEVICE FROM UNKNOWN LOT NUMBER, A REVIEW OF THE RELEVANT MANUFACTURING RECORDS CANNOT BE CONDUCTED. PRIOR TO DISTRIBUTION ALL EVO (PARTIALLY AND FULLY COVERED ESOPHAGEAL 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. AS PER THE INSTRUCTIONS FOR USE, IFU0061-6, WHICH INFORMS THE USER ABOUT THE POTENTIAL COMPLICATIONS "ADDITIONAL COMPLICATIONS INCLUDE, BUT ARE NOT LIMITED TO: STENT MISPLACEMENT AND/OR MIGRATION," ON REVIEW OF THE INFORMATION PROVIDED, THERE IS NO EVIDENCE TO SUGGEST THAT THE USER DID NOT FOLLOW THE INSTRUCTIONS FOR USE. ROOT CAUSE REVIEW: A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED FROM THE AVAILABLE INFORMATION. A POSSIBLE ROOT CAUSE COULD BE ATTRIBUTED TO PATIENT CONDITION RELATED, AS PER INSTRUCTIONS FOR USE, STENT MISPLACEMENT AND/OR MIGRATION ARE LISTED AS A POTENTIAL COMPLICATION FOLLOWING THE PLACEMENT OF THIS DEVICE. SUMMARY: CUSTOMER COMPLAINT IS CONFIRMED BASED ON CUSTOMER TESTIMONY. THE PATIENT OUTCOME IS UNKNOWN. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.

    Additional Manufacturer Narrative · 0

    PMA/510(K) #: AS THE RPN IS UNKNOWN, PROVIDING BOTH 510K NUMBERS FOR PARTIALLY AND FULLY COVERED EVOLUTION ESOPHAGEAL DEVICES, K162717 K093619. DEVICE EVALUATION: THE EVO (ESOPHAGEAL METAL) DEVICE OF UNKNOWN LOT NUMBER WAS NOT RETURNED TO COOK IRELAND FOR EVALUATION. WITH THE INFORMATION PROVIDED, DOCUMENT BASED INVESTIGATION WAS CONDUCTED. THIS FILE WAS CREATED FROM THE ATTACHED ARTICLE TO ADDRESS STENT MIGRATION "LATE COMPLICATION WAS NOTED TO BE MIGRATION IN 9 (21.4%) PATIENTS." DOCUMENTS REVIEW INCLUDING IFU REVIEW: AS THE EVO STENT IS UNKNOWN DEVICE FROM UNKNOWN LOT NUMBER, A REVIEW OF THE RELEVANT MANUFACTURING RECORDS CANNOT BE CONDUCTED. PRIOR TO DISTRIBUTION ALL EVO (PARTIALLY AND FULLY COVERED ESOPHAGEAL 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. AS PER THE INSTRUCTIONS FOR USE, IFU0061-6, WHICH INFORMS THE USER ABOUT THE POTENTIAL COMPLICATIONS "ADDITIONAL COMPLICATIONS INCLUDE, BUT ARE NOT LIMITED TO: STENT MISPLACEMENT AND/OR MIGRATION." ON REVIEW OF THE INFORMATION PROVIDED, THERE IS NO EVIDENCE TO SUGGEST THAT THE USER DID NOT FOLLOW THE INSTRUCTIONS FOR USE. ROOT CAUSE REVIEW: A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED FROM THE AVAILABLE INFORMATION. A POSSIBLE ROOT CAUSE COULD BE ATTRIBUTED TO PATIENT CONDITION RELATED, AS PER INSTRUCTIONS FOR USE, STENT MISPLACEMENT AND/OR MIGRATION ARE LISTED AS A POTENTIAL COMPLICATION FOLLOWING THE PLACEMENT OF THIS DEVICE. SUMMARY: CUSTOMER COMPLAINT IS CONFIRMED BASED ON CUSTOMER TESTIMONY. THE PATIENT OUTCOME IS UNKNOWN. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.

    Description of Event or Problem · 0

    SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO A CORRECTION TO THE COMPLETED INVESTIGATION ANNEX CODES MEDICAL DEVICE PROBLEM CODE (ANNEX A). A24 - ADVERSE EVENT WITHOUT IDENTIFIED DEVICE OR USE PROBLEM UPDATED TO A010402 - MIGRATION.

    Description of Event or Problem · 0

    SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO COMPLETION OF INVESTIGATION.

    Additional Manufacturer Narrative · 1

    AS THIS EVENT WAS REPORTED FROM LITERATURE THE USER FACILITY DETAILS ARE AS FOLLOWS: INTERNAL MEDICINE, UNIVERSITY OF ILLINOIS COM URBANA-CHAMPAIGN, CHAMPAIGN, IL; GASTROENTEROLOGY AND ADVANCED ENDOSCOPY, CARLE FOUNDATION HOSPITAL, URBANA, IL; COLLEGE OF MEDICINE, UNIVERSITY OF ILLINOIS COM URBANA-CHAMPAIGN, URBANA-CHAMPAIGN, IL. INVESTIGATION IS STILL PENDING. A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS. PMA/510(K) #: AS THE RPN IS UNKNOWN, PROVIDING BOTH 510K NUMBERS FOR PARTIALLY AND FULLY COVERED EVOLUTION ESOPHAGEAL DEVICES. K162717 K093619.

    Description of Event or Problem · 1

    EVENT REPORTED FROM LITERATURE. SARWAR 2017- CLINICAL OUTCOMES AND EFFICACY OF FULLY AND PARTIALLY COVERED SELF-EXPANDABLE METALLIC STENTS IN BENIGN AND MALIGNANT ESOPHAGEAL STRICTURES A LATE COMPLICATION WAS NOTED TO BE MIGRATION IN 9 (21.4%) PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1271973 UNKNOWN ESW PROSTHESIS, ESOPHAGEAL ESW COOK IRELAND LTD UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention