BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WALLFLEX ¿ DUODENAL

    MDR report key: 2760860 · Received September 26, 2012

    Report

    Report Number
    3005099803-2012-04368
    Event Type
    Injury
    Date Received
    September 26, 2012
    Date of Event
    September 4, 2012
    Report Date
    September 4, 2012
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    MUM
    PMA / PMN Number
    K062750
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - THE REPORTED EVENT OF STENT POSITIONING ISSUE. THE COMPLAINANT INDICATED THAT THE DEVICE WAS IMPLANTED AND WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX ENTERAL DUODENAL STENT SYSTEM WAS USED DURING A DUODENAL STENT PLACEMENT PROCEDURE ON (B)(6) 2012. ACCORDING TO THE COMPLAINANT, THE INDICATION FOR THE STENT PLACEMENT WAS TREATMENT FOR A MALIGNANT STRICTURE. THE STRICTURE WAS APPROXIMATELY 2CM IN LENGTH. THE PATIENT ANATOMY WAS NOTED TO BE NORMAL. DURING THE PROCEDURE, SIGNIFICANT RESISTANCE WAS ENCOUNTERED WHEN DEPLOYING THE STENT. THE STENT WAS ABLE TO BE RELEASED BUT, DUE TO THE DIFFICULTY, THE STENT WAS IMPLANTED TOO DISTAL. NO VISIBLE ISSUES WERE NOTICED WITH THE STENT SYSTEM. THE STENT WAS LEFT IMPLANTED AND A SECOND WALLFLEX STENT WAS PLACED TELESCOPING THROUGH THE FIRST STENT. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. THE PATIENT CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WALLFLEX ¿ DUODENAL STENT,METALLIC,EXPANDABLE,DUODENAL MUM BOSTON SCIENTIFIC - GALWAY M00565010 0015362752

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention