BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 1933048 · Received December 20, 2010

    Report

    Report Number
    3005099803-2010-05227
    Event Type
    Injury
    Date Received
    December 20, 2010
    Report Date
    November 29, 2010
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    ESW
    PMA / PMN Number
    K030559
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - MEDICAL INTERVENTION REQUIRED; HOSPITALIZED. (B)(4) - THE REPORTED ISSUE OF STENT BLOCKED/OCCLUDED. THE COMPLAINANT INDICATED THAT THE DEVICE 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 MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A POLYFLEX ESOPHAGEAL STENT WAS IMPLANTED WITHIN THE ESOPHAGUS OF A PATIENT WITH A BENIGN STRICTURE ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINT, POST PROCEDURE THE PATIENT WAS ADMITTED TO THE HOSPITAL WITH DYSPNEA AND DYSPHAGIA. IN THE PHYSICIAN'S ASSESSMENT THE DYSPHAGIA WAS UNRELATED TO THE STENT, BUT TO THE TYPE OF FOOD THE PATIENT CONSUMED. A COMPUTED TOMOGRAPHY SCAN REVEALED EXTRINSIC COMPRESSION OF THE CARINA, WHICH IN THE PHYSICIAN'S ASSESSMENT CAUSED THE DYSPNEA. AN ESOPHAGOGASTRODUODENOSCOPY REVEALED THAT THERE WAS FOOD OCCLUDING THE STENT. THE STENT WAS REMOVED WITHOUT PROBLEM. A GASTROGRAFFIN SWALLOW WAS PERFORMED WHICH SHOWED A VERY LARGE ULCER AND THE PRESENCE OF AN ESOPHAGEAL-TRACHEAL FISTULA. IT WAS REPORTED THAT THE PATIENT DID NOT HAVE A PRE-EXISTING FISTULA. IT WAS REPORTED THAT POST PROCEDURE, ALTHOUGH ASYMPTOMATIC, AND ABLE TO HANDLE ORAL SECRETIONS, THE PATIENT WAS ORDERED TO BE NPO (NOTHING BY MOUTH). THE PHYSICIAN PLACED THE PATIENT ON INTRAVENOUS FLUIDS. A SECOND GASTROGRAFFIN SWALLOW WAS PERFORMED 72 HOURS POST PROCEDURE, AND THE PATIENT WAS PUT ON TOTAL PARENTAL NUTRITION. ADDITIONAL FOLLOW UP REPORTED THAT THE PATIENT IS STILL HAVING TROUBLE BREATHING AND THE FISTULA IS STILL PRESENT. THE PATIENT WAS ADMITTED TO THE INTENSIVE CARE UNIT, AND IS NOT DOING WELL. THE PHYSICIAN PLANNED TO PLACE A DYNAMIC Y STENT; HOWEVER, DUE TO THE CONDITION OF THE PATIENT, NO STENT HAS BEEN PLACED. THE PATIENT IS CURRENTLY IN THE ICU.

    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 BOSTON SCIENTIFIC - MARLBOROUGH UNK328

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R