BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOLUTION ESOPHAGEAL STENT SYSTEM

    MDR report key: 1080950 · Received July 23, 2008

    Report

    Report Number
    3001845648-2008-00006
    Event Type
    Injury
    Date Received
    July 23, 2008
    Date of Event
    June 26, 2008
    Report Date
    June 27, 2008
    Manufacturer
    COOK IRELAND LTD
    Product Code
    ESW
    PMA / PMN Number
    K080359
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    OUR EVAL SUGGESTS THAT FORCE APPLIED BY THE USER WHEN USING THE MOUSE TOOTH FORCEPS BROKE THE PART OF THE STENT THAT IS USED FOR RE-POSITIONING. EVAL: ONE EVOLUTION ESOPHAGEAL STENT WAS RETURNED FOR EVAL. UPON VISUAL EXAMINATION, IT WAS NOTED THAT THE PART OF THE STENT THAT IS PULLED TO RE-POSITION IS BROKEN. ALTHOUGH THIS PART OF THE STENT IS BROKEN, THE ENDS REMAINED ATTACHED TO THE STENT; NO PORTION HAD DETACHED FROM THE STENT. THE APPEARANCE OF THE BROKEN AREA SUGGESTS EXCESSIVE PRESSURE HAD BEEN APPLIED DURING THE ATTEMPT TO REPOSITION THE STENT, PERHAPS WHILE USING THE MOUSE TOOTH FORCEPS. WE WERE UNABLE TO CONDUCT A REVIEW OF THE DEVICE HISTORY OR CONDUCT A SAMPLE TEST FROM THIS LOT BECAUSE THE LOT NUMBER WAS UNABLE TO BE PROVIDED. AFTER A REVIEW OF THE ACCOUNT ORDER HISTORY, THE LOT NUMBER WAS UNABLE TO BE DETERMINED. A REVIEW OF THE COMPLAINT HISTORY FOR THIS PRODUCT FAMILY WAS CONDUCTED. THE LIKELIHOOD FO THIS TYPE OF OCCURRENCE IS RARE. CONCLUSION: OUR EVAL SUGGESTS THAT THE FORCE APPLIED BY THE USER WHEN USING THE MOUSE TOOTH FORCEPS BROKE THE PART OF THE STENT THAT IS USED FOR RE-POSITIONING. THIS OBSERVATION HAS BEEN BROUGHT TO THE ATTN OF THE APPROPRIATE INTERNAL PERSONNEL IN AN EFFORT TO HEIGHTEN AWARENESS. IT IS UNK IF THE AREA TO BE STENTED WAS DILATED BEFORE STENT PLACEMENT. THE INSTRUCTIONS FOR THIS STENT INDICATE THAT THE "AREA TO BE STENTED SHOULD BE DILATED TO A MINIMUM OF 10 MM AND A MAXIMUM OF 14 MM". IF THE AREA TO BE STENTED WAS LESS THAN 10 MM IN DIAMETER, THIS COULD HAVE CREATED RESISTANCE IN REPOSITIONING OF THE STENT. THIS COULD HAVE CONTRIBUTED TO THE NEED FOR ADD'L PRESSURE RESULTING IN BREAKAGE OF THE PART OF THE STENT THAT IS USED FOR REPOSITIONING. THE INSTRUCTIONS FOR USE WARN THE USER THAT THE STENT IS A PERMANENT IMPLANT IS NOT INTENDED TO BE REMOVED. THE INSTRUCTIONS FOR USE ADVISE THE USER THAT ATTEMPTS TO REMOVE THE STENT AFTER PLACEMENT MAY CAUSE DAMAGE TO THE ESOPHAGEAL MUCOSA. REMOVAL OF THE FULLY PLACED STENT DID NOT CAUSE ANY ADVERSE EFFECTS TO THE PT IN THIS CASE. PRIOR TO DISTRIBUTION, ALL ESOPHAGEAL STENT SYS ARE SUBJECTED TO A VISUAL INSPECTION TO ENSURE DEVICE INTEGRITY. A REVIEW OF THE DEVICE HISTORY IS UNK. CORRECTIVE ACTION: THE APPROPRIATE INTERNAL PERSONNEL HAVE BEEN NOTIFIED OF THIS OBSERVATION IN AN EFFORT TO HEIGHTEN AWARENESS. IN AN EFFORT TO REDUCE OCCURRENCES OF THIS NATURE, AN IMPROVEMENT PROJECT HAS BEEN INITIATED. THIS STENT WAS MFG PRIOR TO IMPLEMENTATION OF THE IMPROVEMENT. THE LIKELIHOOD OF THIS TYPE OF OCCURRENCE IS RARE. CUSTOMER QA WILL CONTINUE TO MONITOR FOR COMPLAINT TRENDS.

    Description of Event or Problem · 1

    A NON-COOK STENT HAD PREVIOUSLY BEEN PLACED IN THE PT, BUT THIS STENT HAD MIGRATED. IT IS UNK IF THE STRICTURE HAD BEEN DILATED BETWEEN 10 MM AND 14 MM. A DEVICE WAS THEN PLACED IN THE PT. THE PHYSICIAN USED A MOUSE TOOTH FORCEPS TO REPOSITION THE STENT DIRECTLY AFTER STENT PLACEMENT. IN ATTEMPTING TO RE-POSITION THE STENT, THE PART OF THE STENT THAT IS PULLED TO RE-POSITION THE STENT BROKE. THE PHYSICIAN REMOVED THE ENTIRE STENT (INCLUDING THE PART PULLED TO REPOSITION THE STENT) FROM THE PT WITH THE FORCEPS. THE PT DID NOT REQUIRE HOSPITALIZATION OR SIGNIFICANT PROLONGATION OF HOSPITALIZATION, DUE TO THIS OCCURRENCE. THERE WERE NO ADVERSE EFFECTS ON THE PT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention