BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WALLFLEX ¿ DUODENAL

    MDR report key: 2223518 · Received August 25, 2011

    Report

    Report Number
    3005099803-2011-02892
    Event Type
    Injury
    Date Received
    August 25, 2011
    Date of Event
    August 2, 2011
    Report Date
    August 2, 2011
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    MUM
    PMA / PMN Number
    K062750
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION. : A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED; NO ANOMALIES WERE NOTED THAT COULD BE RELATED TO THIS COMPLAINT. A LABELING REVIEW WAS PERFORMED, AND FROM THE INFORMATION AVAILABLE THIS DEVICE WAS USED PER THE DIRECTIONS FOR USE (DFU) / PRODUCT LABEL. A SEARCH OF THE COMPLAINT DATABASE REVEALED THAT NO SIMILAR COMPLAINTS EXIST FOR THE SPECIFIED LOT. AS THE DEVICE HAS NOT BEEN RETURNED, BOSTON SCIENTIFIC COULD NOT PERFORM A TECHNICAL ANALYSIS. HOWEVER, IT IS LIKELY THAT THIS FAILURE OCCURRED DUE TO ANATOMICAL/PROCEDURAL FACTORS WHICH LIMITED THE DEVICE PERFORMANCE. THEREFORE, THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT.

    Additional Manufacturer Narrative · 1

    (B)(4):THE COMPLAINANT INDICATED THAT THE DEVICE WAS IMPLANTED AND WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE CANNOT 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 (B)(4) STENT WAS USED DURING A ENDOSCOPIC STENT PLACEMENT PROCEDURE ON (B)(6) 2011. ACCORDING TO THE COMPLAINANT, THE PATIENT HAD A STRICTURE AT THE PYLORUS APPROXIMATELY 4CM IN LENGTH. THE STRICTURE WAS NOT DILATED PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, THE STENT SYSTEM WAS ADVANCED OVER A JAGWUIRE GUIDEWIRE AND DEPLOYED SUCCESSFULLY AT THE TARGET SITE UNDER FLUOROSCOPIC AND ENDOSCOPIC VISUALIZATION. HOWEVER, AFTER DEPLOYMENT, THE STENT APPEARED TO SHORTEN "LIKE A PILL BUG." THE PHYSICIAN FELT THAT THE DEPLOYED STENT ACTED DIFFERENTLY THAN EXPECTED OR WHAT HE HAD EXPERIENCED IN THE PAST. THE PHYSICIAN ATTEMPTED TO REPOSITION THE STENT USING FORCEPS, BUT DECIDED TO LEAVE THE STENT IMPLANTED. THE PROCEDURE WAS COMPLETED BY PLACING A SECOND 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 "GOOD." ADDITIONAL INFORMATION RECEIVED AS OF (B)(4) 2011. "THERE WAS NO ANOMALY ON THE PATIENT ANATOMY TO CAUSE THE STENT SHRINK."

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX ENTERAL DUODENAL STENT WAS USED DURING A ENDOSCOPIC STENT PLACEMENT PROCEDURE ON (B)(6), 2011. ACCORDING TO THE COMPLAINANT, THE PATIENT HAD A STRICTURE AT THE PYLORUS APPROXIMATELY 4CM IN LENGTH. THE STRICTURE WAS NOT DILATED PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, THE STENT SYSTEM WAS ADVANCED OVER A JAGWIRE GUIDEWIRE AND DEPLOYED SUCCESSFULLY AT THE TARGET SITE UNDER FLUOROSCOPIC AND ENDOSCOPIC VISUALIZATION. HOWEVER, AFTER DEPLOYMENT, THE STENT APPEARED TO SHORTEN "LIKE A PILL BUG." THE PHYSICIAN FELT THAT THE DEPLOYED STENT ACTED DIFFERENTLY THAN EXPECTED OR WHAT HE HAD EXPERIENCED IN THE PAST. THE PHYSICIAN ATTEMPTED TO REPOSITION THE STENT USING FORCEPS BUT DECIDED TO LEAVE THE STENT IMPLANTED. THE PROCEDURE WAS COMPLETED BY PLACING A SECOND 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 "GOOD."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WALLFLEX ¿ DUODENAL STENT,METALLIC,EXPANDABLE,DUODENAL MUM BOSTON SCIENTIFIC - GALWAY M00565020 14330541

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Required Intervention