BEUDAMED
    FDA Adverse Event Death Summary report: N

    RUSCH POLYFLEX STENT FOR THE ESOPHAGUS W/INTRODUCER/DELIVERY SYSTEM

    MDR report key: 1658602 · Received April 14, 2010

    Report

    Report Number
    3005099803-2010-01747
    Event Type
    Death
    Date Received
    April 14, 2010
    Date of Event
    March 23, 2010
    Report Date
    March 24, 2010
    Manufacturer
    WILLY RUESCH GMBH
    Product Code
    ESW
    PMA / PMN Number
    K030559
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    NOTE: THIS REPORT PERTAINS TO ONE OF THREE COMPLAINTS THAT OCCURRED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT # 3005099803-2010-01746 AND 3005099803-2010-01693 FOR THE OTHER ASSOCIATED DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX ESOPHAGEAL STENT, A POLYFLEX ESOPHAGEAL STENT AND A RESOLUTION HEMOSTASIS CLIPPING DEVICE WERE INVOLVED IN A PROCEDURE ON A (B) (6) PATIENT WITH A PRE-EXISTING TRACHEAL ESOPHAGEAL FISTULA.ACCORDING TO THE COMPLAINANT, THE PATIENT WAS BORN WITH A PRE-EXISTING TRACHEAL ESOPHAGEAL FISTULA AND HAD UNDERGONE PRIOR SURGERIES TO ALLEVIATE THIS CONDITION. ON (B) (6) 2010 A WALLFLEX ESOPHAGEAL STENT WAS IMPLANTED WITHOUT ISSUE IN THE PATIENT¿S ESOPHAGUS. ON (B) (6) 2010, THE PATIENT WAS COUGHING UP BLOOD. THE PHYSICIAN EXAMINED THE ESOPHAGUS THROUGH A SCOPE AND REPORTED THAT THE ESOPHAGUS ¿LOOKED FINE¿. THE PHYSICIAN THEN PROCEEDED TO REMOVE THE WALLFLEX STENT WHICH REVEALED A BLEEDING FISTULA. THE PHYSICIAN ATTEMPTED TO STOP THE BLEEDING WITH A RESOLUTION HEMACLIP AND INJECTION, BUT WAS UNABLE TO PLACE THE CLIP PROPERLY DUE TO EXCESSIVE BLEEDING. THE PHYSICIAN IMPLANTED A POLYFLEX ESOPHAGEAL STENT WHICH STOPPED THE BLEEDING AND STABILIZED THE PATIENT.APPROXIMATELY FOUR HOURS LATER, THE PATIENT WENT IN FOR SURGERY IN ORDER TO SURGICALLY REPAIR THE BLEED. WHEN THE SURGEON EXAMINED THE PATIENT, IT APPEARED THAT THE POLYFLEX STENT MAY HAVE MIGRATED. DURING THE SURGERY, MANIPULATION OF THE ESOPHAGUS CAUSED THE PATIENT TO RE-BLEED. THE PATIENT BLED OUT AND PASSED AWAY. THE PHYSICIAN COMMENTED THAT THE BLEEDING WAS POSSIBLY A RESULT OF SCAR TISSUE THAT HAD FORMED FROM PREVIOUS SURGERIES AND ATTACHED TO THE AORTA, BUT THAT THIS COULD NOT BE CONFIRMED AT THIS TIME.DESPITE NUMEROUS ATTEMPTS, BOSTON SCIENTIFIC HAS BEEN UNABLE TO ASCERTAIN ADDITIONAL INFORMATION SURROUNDING THE CIRCUMSTANCES OF THE EVENT. A COPY OF THE AUTOPSY REPORT HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RUSCH POLYFLEX STENT FOR THE ESOPHAGUS W/INTRODUCER/DELIVERY SYSTEM PROSTHESIS, ESOPHAGEAL ESW WILLY RUESCH GMBH UNK328

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Death