BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WALLFLEX? ESOPHAGEAL

    MDR report key: 4242808 · Received November 11, 2014

    Report

    Report Number
    3005099803-2014-03615
    Event Type
    Injury
    Date Received
    November 11, 2014
    Date of Event
    October 21, 2014
    Report Date
    October 22, 2014
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    ESW
    PMA / PMN Number
    K073266
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION RESULTS: A VISUAL AND FUNCTIONAL EXAMINATION OF THE COMPLAINT DEVICE COULD NOT BE PERFORMED SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. A LABELING REVIEW WAS PERFORMED, AND FROM THE INFORMATION AVAILABLE THIS DEVICE WAS NOT USED PER THE DIRECTIONS FOR USE (DFU) / PRODUCT LABEL, THIS DEVICE IS INTENDED FOR MAINTAINING ESOPHAGEAL LUMINAL PATENCY IN ESOPHAGEAL STRICTURES CAUSED BY INTRINSIC AND/OR EXTRINSIC MALIGNANT TUMORS, AND OCCLUSION OF CONCURRENT ESOPHAGEAL FISTULAS". HOWEVER, THIS DEVICE WAS USED TO TREAT A BENIGN STRICTURE. THEREFORE THE MOST PROBABLE ROOT CAUSE CLASSIFICATION IS USER ERROR. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED; NO ANOMALIES WERE NOTED.

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT WAS UNABLE TO REPORT THE LOT NUMBER; THEREFORE, THE MANUFACTURE DATE AND EXPIRATION DATE ARE UNKNOWN. HOWEVER, THE COMPLAINANT STATED THAT THE DEVICE WAS USED PRIOR TO THE EXPIRATION DATE REPORTED EVENT OF STENT BLOCKED/OCCLUDED. REPORTED EVENT OF STENT DIFFICULT TO REMOVE. REPORTED EVENT OF STENT COVER DAMAGED. A VISUAL AND FUNCTIONAL EXAMINATION OF THE COMPLAINT DEVICE COULD NOT BE PERFORMED SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE MOST PROBABLE ROOT CAUSE CLASSIFICATION OF THIS INVESTIGATION IS OPERATIONAL CONTEXT. THIS IS DEFINED AS A COMPLAINT THAT IS ASSOCIATED WITH A PRODUCT THAT MEETS THE DESIGN & MANUFACTURE SPECIFICATION BUT DUE TO ANATOMICAL/PROCEDURAL FACTORS ENCOUNTERED DURING THE PROCEDURE, PERFORMANCE WAS LIMITED. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED; NO ANOMALIES WERE NOTED. A LABELING REVIEW WAS PERFORMED, AND FROM THE INFORMATION AVAILABLE THIS DEVICE WAS USED PER THE DIRECTIONS FOR USE (DFU) / PRODUCT LABEL.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX PARTIALLY COVERED ESOPHAGEAL STENT WAS IMPLANTED IN THE ESOPHAGUS DURING A GASTROSCOPY PROCEDURE PERFORMED ON (B)(6) 2014. REPORTEDLY, THE STENT WAS IMPLANTED TO TREAT A BENIGN STRICTURE. ACCORDING TO THE COMPLAINANT, ON (B)(6) 2014, DURING A PLANNED STENT REMOVAL, THE PHYSICIAN FOUND THAT THERE WAS A LOT OF GRANULATION TISSUE INGROWTH AT BOTH THE DISTAL AND PROXIMAL ENDS OF THE STENT. THE PHYSICIAN ATTEMPTED TO REMOVE THE STENT BUT THE RETRIEVAL SUTURE BROKE, SO THE PHYSICIAN ATTEMPTED TO GRASP THE STENT WIRE HOWEVER THE STENT WAS UNABLE TO BE REMOVED. THE PHYSICIAN NOTED A LONG, LENGTHWISE TEAR ON THE STENT COVERING WHICH WAS COVERED IN TISSUE INGROWTH. THE STENT REMAINED IMPLANTED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX PARTIALLY COVERED ESOPHAGEAL STENT WAS IMPLANTED IN THE ESOPHAGUS DURING A GASTROSCOPY PROCEDURE PERFORMED ON (B)(6) 2014. REPORTEDLY, THE STENT WAS IMPLANTED TO TREAT A BENIGN STRICTURE. ACCORDING TO THE COMPLAINANT, ON (B)(6) 2014, DURING A PLANNED STENT REMOVAL, THE PHYSICIAN FOUND THAT THERE WAS A LOT OF GRANULATION TISSUE INGROWTH AT BOTH THE DISTAL AND PROXIMAL ENDS OF THE STENT. THE PHYSICIAN ATTEMPTED TO REMOVE THE STENT BUT THE RETRIEVAL SUTURE BROKE, SO THE PHYSICIAN ATTEMPTED TO GRASP THE STENT WIRE HOWEVER THE STENT WAS UNABLE TO BE REMOVED. THE PHYSICIAN NOTED A LONG, LENGTHWISE TEAR ON THE STENT COVERING WHICH WAS COVERED IN TISSUE INGROWTH. THE STENT REMAINED IMPLANTED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    725163 WALLFLEX? ESOPHAGEAL PROSTHESIS, ESOPHAGEAL ESW BOSTON SCIENTIFIC - GALWAY M00516930

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention