BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WALLFLEX ENTERAL COLONIC STENT

    MDR report key: 1012952 · Received March 13, 2008

    Report

    Report Number
    3005099803-2008-00265
    Event Type
    Injury
    Date Received
    March 13, 2008
    Report Date
    February 13, 2008
    Manufacturer
    BOSTON SCIENTIFIC IRELAND, LTD
    Product Code
    MQR
    PMA / PMN Number
    K042065
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMLAINANT STATED THAT THE LOT NUMBER IS UNK; THEREFORE, THE MFR DATE IS UNK. THE DEVICE REMAINS IMPLANTED; THEREFORE, A DEVICE EVAL CANNOT BE PERFORMED. THE RELATIONSHIP BETWEEN THE DEVICE AND THE REPORTED EVENT IS UNDETERMINED. THE JAN 2008 15-MONTH WALLFLEX ENTERAL STENT PROD FAMILY COMPLAINT TREND REPORT, INCLUSIVE OF ALL FAILURE MODES, WAS REVIEWED; NO UNFAVORABLE TREND WAS NOTED.

    Description of Event or Problem · 1

    THIS REPORT PERTAINS TO THE FIRST OF TWO DEVICES USED DURING THE SAME PROCEDURE. REFER TO ASSOCIATED MFR REPORT #3005099803-2008-00266. THE DATE OF EVENT IS UNK; HOWEVER, THE PERFORATION OCCURRED SOMETIME IN 2008. A WALLFLEX ENTERAL COLONIC STENT WAS USED DURING A STENT PLACEMENT PROCEDURE IN A FEMALE PT (AGE AND WEIGHT UNK) ON ORIGINAL DATE. ACCORDING TO THE COMPLAINANT, " A 12 CM WALLFLEX (ENTERAL) COLONIC STENT WAS PLACED THROUGH (A) STRICTURE. THE STRICTURE WAS VERY FRIABLE AND LONG, AND HENCE A 6 CM WALLFLEX (ENTERAL) COLONIC STENT WAS PLACED THROUGH THE INITIAL STENT TO FORM A LONG SEGMENT. (THE) PT WAS DECOMPRESSED NICELY ELEVEN DAYS LATER WHEN SHE RETURNED TO THE HOSP WITH PAIN." THE PHYSICIAN FOUND THAT "THE PROXIMAL PART OF THE STENT HAD PERFORATED HER BOWEL. "THE PT UNDERWENT SURGERY FOR (THE) PERFORATION, AND IS CURRENTLY IN ICU". THE PT'S CONDITION HAS BEEN REPORTED AS "STABLE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WALLFLEX ENTERAL COLONIC STENT MQR BOSTON SCIENTIFIC IRELAND, LTD UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization| R