BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WALLFLEX¿ BILIARY RX STENT SYSTEM

    MDR report key: 6211335 · Received December 28, 2016

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    Report

    Report Number
    3005099803-2016-04057
    Event Type
    Malfunction
    Date Received
    December 28, 2016
    Date of Event
    January 14, 2016
    Report Date
    December 6, 2016
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    FGE
    PMA / PMN Number
    SIMILAR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(6) CLINICAL TRIAL 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 ON DECEMBER 06, 2016 THAT A WALLFLEX BILIARY RX FULLY COVERED RMV STENT WAS IMPLANTED DURING A STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2015 AS PART OF THE (B)(6) CLINICAL TRIAL. THE PATIENT HAD A HISTORY OF ENDOSCOPIC CYSTOGASTROSTOMY FOR PANCREATIC PSEUDOCYST AND WAS ENROLLED IN THE STUDY FOR TREATMENT OF PANCREATIC PSEUDOCYST WITH A STENT INDWELL OF GREATER THAN 3 MONTHS. THE PATIENT UNDERWENT CT SCAN FOR IMAGING/BIOPSY AND ENDOSCOPIC ULTRASOUND (EUS) GUIDED CYSTGASTROSTOMY DURING THE STENT PLACEMENT PROCEDURE ON (B)(6) 2015. THE PROCEDURE WAS DONE IN AN OUTPATIENT SETTING. A PRIOR BILIARY SPHINCTEROTOMY HAD BEEN PERFORMED AND PROPHYLACTIC ANTIBIOTICS WERE ADMINISTERED. THE STUDY STENT WAS IMPLANTED ON (B)(6) 2015 IN A SATISFACTORY MANNER. ON (B)(6) 2016, THE STUDY STENT WAS NOTED TO HAVE A COMPLETE DISTAL MIGRATION WHICH WAS NOT DUE TO STRICTURE RESOLUTION. THERE WERE NO ADVERSE EVENTS REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2016 THAT A WALLFLEX¿ BILIARY RX FULLY COVERED RMV STENT WAS IMPLANTED DURING A STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2015 AS PART OF THE (B)(6) CLINICAL TRIAL. THE PATIENT HAD A HISTORY OF ENDOSCOPIC CYSTOGASTROSTOMY FOR PANCREATIC PSEUDOCYST AND WAS ENROLLED IN THE STUDY FOR TREATMENT OF PANCREATIC PSEUDOCYST WITH A STENT INDWELL OF GREATER THAN 3 MONTHS. THE PATIENT UNDERWENT CT SCAN FOR IMAGING/BIOPSY AND ENDOSCOPIC ULTRASOUND (EUS) GUIDED CYSTGASTROSTOMY DURING THE STENT PLACEMENT PROCEDURE ON (B)(6) 2015. THE PROCEDURE WAS DONE IN AN OUTPATIENT SETTING. A PRIOR BILIARY SPHINCTEROTOMY HAD BEEN PERFORMED AND PROPHYLACTIC ANTIBIOTICS WERE ADMINISTERED. THE STUDY STENT WAS IMPLANTED ON (B)(6) 2015 IN A SATISFACTORY MANNER. ON (B)(6) 2016, THE STUDY STENT WAS NOTED TO HAVE A COMPLETE DISTAL MIGRATION WHICH WAS NOT DUE TO STRICTURE RESOLUTION. THERE WERE NO ADVERSE EVENTS REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION RECEIVED ON DECEMBER 28, 2016: IT WAS REPORTED THAT THE STUDY STENT WAS PLACED DURING AN EUS-GUIDED TRANSGASTRIC CYSTOGASTROSTOMY AND THE COMPLETE DISTAL MIGRATION OF THE STENT OCCURRED AFTER SYMPTOMATIC AND RADIOGRAPHIC RESOLUTION OF THE PSEUDOCYST. NO INTERVENTION WAS PERFORMED TO ADDRESS THE MIGRATED STENT, AND THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THE STENT MIGRATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    858028 WALLFLEX¿ BILIARY RX STENT SYSTEM CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC - GALWAY M00570470 18080538

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR