BEUDAMED
    FDA Adverse Event Death Summary report: N

    EVOLUTION ESOPHAGEAL STENT SYSTEM

    MDR report key: 2007056 · Received February 23, 2011

    Report

    Report Number
    3001845648-2011-00010
    Event Type
    Death
    Date Received
    February 23, 2011
    Date of Event
    January 28, 2011
    Report Date
    January 28, 2011
    Manufacturer
    COOK IRELAND LTD
    Product Code
    ESW
    PMA / PMN Number
    K080359
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    A DOCUMENT BASED INVESTIGATION WAS CARRIED OUT AS THE DEVICE INVOLVED IS NOT AVAILABLE FOR RETURN AS IT WAS IMPLANTED IN THE PT. IT IS NOT POSSIBLE TO CONFIRM THIS COMPLAINT OR DETERMINE THE ROOT CAUSE AS THE DEVICE WAS NOT RETURNED FOR EVALUATION. DUE TO A VARIETY OF CLINICAL CONDITIONS SUCH AS PT ANATOMY AND PROGRESSION OF DISEASE, THE CAUSE OF THE COMPLAINT CANNOT BE DETERMINED. WE WERE UNABLE TO CONDUCT A SAMPLE TEST FROM THIS LOT AS THERE WERE NO DEVICES REMAINING IN STOCK AT COOK (B)(4). A REVIEW OF THE DEVICE MANUFACTURING RECORDS REVEALED NO DISCREPANCIES THAT COULD HAVE CAUSED THE COMPLAINT ISSUE. PRIOR TO DISTRIBUTION, ALL ESOPHAGEAL STENT SYSTEMS ARE SUBJECTED TO A VISUAL INSPECTION TO ENSURE DEVICE INTEGRITY. A REVIEW OF THE 2-YEAR COMPLAINT HISTORY FOR THIS PRODUCT FAMILY WAS CONDUCTED. THIS TYPE OF REPORT REPRESENTS AN UNUSUAL OCCURRENCE. THE INSTRUCTIONS FOR USE WARN THE USER THAT PERFORATION AND MIGRATION ARE POTENTIAL COMPLICATIONS OF THIS PROCEDURE. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED TO IDENTIFY POTENTIAL EMERGING TRENDS. NO CORRECTIVE ACTION WARRANTED AT THIS TIME AS THIS COMPLAINT WAS UNABLE TO BE VERIFIED AN THIS REPRESENTS AN UNUSUAL OCCURRENCE.

    Description of Event or Problem · 1

    THE STENT DEPLOYED WELL AND ON REVIEW WITH THE ENDOSCOPE THE PHYSICIAN DISCOVERED THAT THE STENT WAS DEPLOYED FROM THE OESOPHAGUS TO "OUTSIDE STOMACH". THE PHYSICIAN ADVISED THAT HE WAS UNSURE OF THE EXACT SITE OF THE PERFORATION AS IT WAS VIEWED THROUGH THE SCOPE. IT MAY HAVE BEEN THE STOMACH, OR THE SITE OF THE TUMOR AT THE ESOPHAGEAL JUNCTION. THE METAL STENT REMAINED INSIDE THE PT. NO ADDITIONAL PROCEDURES WERE PERFORMED AS THE PHYSICIAN ADVISED THAT HE COULD NOT OPERATE ON THIS PT. THE ADVERSE EFFECT TO THE PT WAS THE APPARENT PERFORATION, AND THE ASSUMPTION THAT THE PT WOULD NOT BE TREATED FOR THIS LIFE THREATENING EVENT. THE PT SUBSEQUENTLY DIED ON (B)(6) 2011.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EVOLUTION ESOPHAGEAL STENT SYSTEM ESW PROSTHESIS, ESOPHAGEAL ESW COOK IRELAND LTD C548162

    Patients

    Seq Age Sex Outcome Treatment
    1 96 YR Death