BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVOLUTION ESOPHAGEAL CONTROLLED-RELEASE STENT - FULLY COVERED

    MDR report key: 4322000 · Received November 27, 2014

    Report

    Report Number
    3001845648-2014-00284
    Event Type
    Malfunction
    Date Received
    November 27, 2014
    Date of Event
    October 27, 2014
    Report Date
    October 30, 2014
    Manufacturer
    COOK IRELAND LTD
    Product Code
    ESW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS NOT REGISTERED FOR SALE IN THE US. INDICATION FOR USE HAS BEEN CONFIRMED AS MALIGNANT. THIS DEVICE IS CONSIDERED A 'SIMILAR' DEVICE TO OTHER METAL STENT/SETS (EVOLUTION) DEVICES THAT ARE CURRENTLY MARKETED IN THE US WITH A MALIGNANT INDICATION FOR USE. SIMILAR METAL STENT/SETS (EVOLUTION) DEVICES ARE CURRENTLY MARKETED IN THE US UNDER THE FOLLOWING 510 (K) #'S: K080359 AND K093619. FDA MDR REPORT REQUIRES BASED ON THE REPORTING PRECEDENCE ESTABLISHED FOR THIS PRODUCT FAMILY FOR REMOVAL OF A PERMANENT STENT (DEPLOYMENT RELATED) AND ALSO THE STENT FAILING TO EXPAND. TO DATE THE DEVICE INVOLVED IN THIS EVENT HAS NOT BEEN RECEIVED FOR EVAL. WITH THE INFO PROVIDED A DOCUMENT BASED INVESTIGATION WAS CARRIED OUT. AS THE DEVICE HAS NOT BEEN RECEIVED; THEREFORE THE CAUSE OF THIS COMPLAINT COULD NOT BE CONCLUSIVELY DETERMINED. THE CUSTOMER COMPLAINT WAS CONFIRMED BASED ON CUSTOMER TESTIMONY. PRIOR TO DISTRIBUTION EVOLUTION DEVICES ARE SUBJECTED TO A VISUAL AND FUNCTIONAL CHECKS TO ENSURE DEVICE INTEGRITY, THERE IS A SPECIFIC CHECK TO DEPLOY THE STENT APPROX 50% AND RECAPTURE IT TO ENSURE IT FUNCTIONS CORRECTLY. A REVIEW OF THE MFG RECORDS FOR EVO-FC-R-20-25-10-E OR LOT C924620 DID NOT REVEAL ANY DISCREPANCIES THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. FROM THE INFO PROVIDED, THE PT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR EMERGING TRENDS.

    Description of Event or Problem · 1

    STENT PLACEMENT OF EVOLUTION OESOPHAGEAL STENT DUE TO A STRICTURE IN THE LOWER TO MID OESOPHAGEUS. STENT WAS DEPLOYED BY COMPLETELY RETRACTING OUTER SHEATH AND RELEASING STENT BY PULLING PIN. IT WAS CLEARLY EVIDENT THAT THE PROXIMAL FLANGE OF THE STENT DID NOT OPEN PROPERLY. WHILE THE INNER CATHETER WAS BEING REMOVED, THE TIP GOT STUCK ON A SUTURE ON THE PROXIMAL NARROWING OF THE STENT RESULTING IN BOTH THE STENT AND INNER CATHETER BEING PULLED OUT OF THE OESOPHAGEUS. THE CASE WAS COMPLETED BY PLACING A BS WALLFLEX STENT. NO ADVERSE EFFECTS TO THE PT WERE REPORTED AS OCCURRING AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    770754 EVOLUTION ESOPHAGEAL CONTROLLED-RELEASE STENT - FULLY COVERED PROSTHESIS, ESOPHAGEAL ESW COOK IRELAND LTD C924620

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK