BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WALLSTENT ENTERAL ENDOPROSTHESIS

    MDR report key: 1024454 · Received April 3, 2008

    Report

    Report Number
    3005099803-2008-00320
    Event Type
    Injury
    Date Received
    April 3, 2008
    Date of Event
    March 4, 2008
    Report Date
    March 4, 2008
    Manufacturer
    BOSTON SCIENTIFIC IRELAND LTD.
    Product Code
    MQR
    PMA / PMN Number
    K000281
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE REMAINS IMPLANTED; THEREFORE, A DEVICE EVALUATION CANNOT BE PERFORMED. THE LOT NUMBER WAS NOT PROVIDED BY THE COMPLAINANT; THEREFORE, THE CUSTOMER'S SHIPMENT HISTORY WAS REVIEWED. THIS IDENTIFIED THREE LOTS (9830231, 11319159 AND 11179603) THAT WERE SHIPPED TO THE CUSTOMER PRIOR TO THE EVENT DATE. REVIEW OF THE DEVICE HISTORY RECORD FOR EACH LOT WERE COMPLETED; NO ANOMALIES WERE NOTED. THE FEBRUARY 2007 15-MONTH NG ENTERAL PRODUCT FAMILY COMPLAINT TREND REPORT, INCLUSIVE OF ALL FAILURE MODES, WAS REVIEWED; NO UNFAVORABLE TREND WAS NOTED. FOR COMPLAINT TRENDING PURPOSES, THE WALLSTENT ENTERAL PROSTHESIS PRODUCT FAMILY IS CONTAINED WITHIN THE NG ENTERAL PRODUCT FAMILY. THE "WARNINGS" SECTION OF THE PRODUCT DIRECTIONS FOR USE (DFU) STATES: "STENTS CANNOT BE REPOSITIONED AFTER THE DEPLOYMENT THRESHOLD HAS BEEN EXCEEDED." ADDITIONALLY, THE "PROCEDURE" SECTION OF THE PRODUCT DIRECTIONS FOR USE STATES: "CAUTION: A STENT CANNOT BE REPOSITIONED AFTER THE DEPLOYMENT THRESHOLD HAS BEEN EXCEEDED." SINCE IT WAS REPORTED THAT THE PHYSICIAN REPOSITIONED THE STENT AFTER DEPLOYMENT AND SINCE THE PRODUCT DFU WARNS AND CAUTIONS THE USER THAT THE STENT CANNOT BE REPOSITIONED AFTER DEPLOYMENT, IT IS CONCLUDED THAT THE DEVICE WAS MISUSED. THE CAUSE OF THE PERFORATION IS UNDETERMINED.

    Description of Event or Problem · 1

    A WALLSTENT ENTERAL ENDOPROSTHESIS WAS PLACED IN THE DUODENUM OF A FEMALE PATIENT (AGE AND WEIGHT UNK) IN 2008. ACCORDING TO THE COMPLAINANT, THE PHYSICIAN "PLACED THE STENT TOO FAR DISTALLY, WHICH PUT THE STRICTURE AT THE PROXIMAL END OF THE STENT, RATHER THAN IN THE MIDDLE. AN OLYMPUS GRASPING FORCEPS MODEL UNKNOWN WAS THEN USED TO MANUALLY PULL THE STENT BACK UNTIL THE STRICTURE WAS CORRECTLY POSITIONED IN THE CENTER OF THE STENT." THE PHYSICIAN STATED THAT "HE PERFORATED THE PATIENT DURING THAT MANEUVER" AND HE ATTRIBUTED IT TO EITHER "THE STENT, THE FORCEPS OR BOTH." THE PATIENT WAS PLACED ON "ANTIBIOTICS AND SENT TO ICU FOR THE NIGHT." ON THE NEXT DAY, THE PHYSICIAN STATED THAT "THE PERFORATION APPEARS TO HAVE SEALED ITSELF OFF, REQUIRING NO FURTHER INTERVENTION." THE PATIENT'S CONDITION WAS REPORTED AS "STABLE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WALLSTENT ENTERAL ENDOPROSTHESIS MQR BOSTON SCIENTIFIC IRELAND LTD. M00565590 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization| R