BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN

    MDR report key: 9472774 · Received December 16, 2019

    Report

    Report Number
    3001845648-2019-00732
    Event Type
    Injury
    Date Received
    December 16, 2019
    Date of Event
    December 15, 2016
    Report Date
    December 16, 2019
    Manufacturer
    COOK IRELAND LTD
    Product Code
    ESW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE 510(K) NUMBER COULD BE K162717 OR K093619, HOWEVER AS THE RPN HAS NOT BEEN PROVIDED IT CANNOT BE CONFIRMED. THIS REPORT IS BEING SUBMITTED AS A CANCELLATION REPORT. THE LITERATURE REVIEW CONFIRMS THAT A COOK STENT WAS NOT USED FOR THE CASE OF REFLUX.

    Description of Event or Problem · 0

    THIS REPORT IS BEING SUBMITTED AS A CANCELLATION REPORT. THE LITERATURE REVIEW CONFIRMS THAT A COOK STENT WAS NOT USED FOR THE CASE OF REFLUX.

    Additional Manufacturer Narrative · 1

    THE 510(K) NUMBER COULD BE K162717 OR K093619, HOWEVER AS THE RPN HAS NOT BEEN PROVIDED IT CANNOT BE CONFIRMED. THE INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSION. FACILITY DETAILS: DEPARTMENT OF GASTROENTEROLOGY, ENDOSCOPY DIVISION (1), DEPARTMENT OF GASTROENTEROLOGY, SURGERY DIVISION (2), CANCER INSTITUTE OF THE UNIVERSITY OF (B)(6).

    Description of Event or Problem · 1

    ADVERSE EVENTS OF SELF-EXPANDABLE ESOPHAGEAL METALLIC STENTS IN PATIENTS WITH LONG-TERM SURVIVAL FROM ADVANCED MALIGNANT DISEASE. MEDEIROS 2017. FOR LESIONS LOCATED IN THE PROXIMAL ESOPHAGUS, WE USED A DEDICATED MODEL OF A PARTIALLY COVERED STENT WITH A LOWPROFILE, PROXIMAL FLARE SHAPE (CHOOSTENT; (B)(4)). FOR LESIONS LOCATED IN THE MID-ESOPHAGUS, WE USED A STANDARD PARTIALLY COVERED STENT OR, LESS OFTEN, A FULLY COVERED STENT, WITH AN 18- TO 23-MM BODY DIAMETER AND 23- TO 28-MM FLARE DIAMETER (WALLFLEX AND ULTRAFLEX [BOSTON SCIENTIFIC, (B)(4)], EVOLUTION [WILSON COOK MEDICAL, (B)(4)], HANAROSTENT [(B)(4)], OR ENDOFLEX [(B)(4)]). SEVERE GASTROESOPHAGEAL REFLUX (HEART BURN OR REGURGITATION ASSOCIATED WITH THE FINDINGS OF PEPTIC EROSIONS AT ENDOSCOPY) - 1 CASE. ''RESTENTING WAS PERFORMED FOR 1 PATIENTS FOR DUE SEVERE REFLUX.'' CANNOT CONFIRM THAT AN EVO-PC/FC-E (UNKNOWN) WAS USED -FILE BEING OPENED CONSERVATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1268661 UNKNOWN ESW PROSTHESIS, ESOPHAGEAL ESW COOK IRELAND LTD UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention