BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WALLFLEX? ESOPHAGEAL

    MDR report key: 3881896 · Received June 18, 2014

    Report

    Report Number
    3005099803-2014-02319
    Event Type
    Injury
    Date Received
    June 18, 2014
    Date of Event
    May 29, 2014
    Report Date
    May 29, 2014
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    ESW
    PMA / PMN Number
    K073266
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL EXAMINATION OF THE RETURNED DEVICE FOUND THAT THE OUTER SHEATH HAD BEEN RETRACTED PROXIMAL TO THE STENT HOLDER. THERE WAS A SLIGHT KINK IN THE BLUE OUTER SHEATH IN ITS MID SECTION. NO OTHER ISSUES WERE NOTED WITH THE DEVICE AND DURING ANALYSIS THERE WAS NO ISSUE IN MOVEMENT OF THE OUTER SHEATH ALONG THE SHAFT. THE STENT WAS FULLY EXPANDED AND NO ISSUES WERE NOTED ITS PROFILE. THE STENT LENGTH MEASURED 155MM WHILE THE SPECIFICATION IS 153 MM +/- 10 MM. THE STENT DIAMETER MEASURED 18MM IN DIAMETER WHILE THE SPECIFICATION IS 18.0 MM ± 1.0 MM PER PRODUCT SPECIFICATION AND NO ISSUES NOTED WITH THE PROFILE OF THE COMPRESSION SLEEVE. DUE TO THE CONDITION OF THE RETURNED DEVICE, THE NOTED DAMAGES INDICATE DIFFICULTY WAS EXPERIENCED DURING DEPLOYMENT AND ARE LIKELY DUE TO ANATOMICAL OR PROCEDURAL FACTORS SUCH AS STRICTURE IS TOO TIGHT OR MANEUVERING OF THE DEVICE. THEREFORE, A REVIEW AND ANALYSIS OF ALL AVAILABLE INFORMATION INDICATED THAT THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY, AND PRODUCT SPECIFICATIONS AT THE TIME OF RELEASE TO DISTRIBUTION.  A SEARCH OF THE COMPLAINT DATABASE CONFIRMED THAT NO SIMILAR COMPLAINTS EXIST FOR THE SPECIFIED BATCH.  A LABELING REVIEW WAS PERFORMED AND, FROM THE INFORMATION AVAILABLE, THIS DEVICE WAS USED PER THE DIRECTIONS FOR USE (DFU) / PRODUCT LABEL.

    Additional Manufacturer Narrative · 1

    (B)(4) FOR THE REPORTED EVENT OF STENT POSITIONING PROBLEM. THE DEVICE HAS BEEN RECEIVED FOR ANALYSIS; HOWEVER THE EVALUATION HAS NOT BEEN COMPLETED. THEREFORE, THE CAUSE OF THE REPORTED MALFUNCTION HAS NOT BEEN DETERMINED. UPON 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

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX ESOPHAGEAL STENT WAS ATTEMPTED TO BE IMPLANTED IN THE ESOPHAGUS DURING AN ESOPHAGEAL STENT IMPLANTATION PROCEDURE PERFORMED ON (B)(6), 2014. ACCORDING TO THE COMPLAINANT, THE STENT WAS USED TO TREAT A SEVERELY CALCIFIED AND TORTUOUS LESION, WITH 70% STENOSIS, A LENGTH OF 8MM AND A DIAMETER OF 18MM LOCATED IN THE ESOPHAGUS. THE STRICTURE WAS BENT AT AN ANGLE GREATER THAN 46 DEGREE BUT LESS THAN 90 DEGREES. DURING THE PROCEDURE, AFTER DILATING THE LESION WITH A CRE BALLOON UNDER X-RAY, THE PHYSICIAN ADVANCED THE DEVICE TO THE TARGET AREA AND RELEASED THE STENT, HOWEVER, THE STENT WOULD NOT DETACH FROM THE DELIVERY SYSTEM. THE PHYSICIAN MOVED THE DELIVERY SYSTEM BUT THE STENT STILL WOULD NOT DETACH. FORCE WAS ENHANCED AND THE STENT WAS DEPLOYED COMPLETELY BUT NOT AT THE DESIRED SITE. AN X-RAY WAS PERFORMED TO CHECK THE STENT PLACEMENT AND, IT WAS CONFIRMED THAT THE STENT WAS NOT IN THE DESIRED LOCATION. THE PHYSICIAN REMOVED THE STENT FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER WALLFLEX ESOPHAGEAL STENT. 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 ESOPHAGEAL STENT WAS ATTEMPTED TO BE IMPLANTED IN THE ESOPHAGUS DURING AN ESOPHAGEAL STENT IMPLANTATION PROCEDURE PERFORMED ON (B)(6) 2014. ACCORDING TO THE COMPLAINANT, THE STENT WAS USED TO TREAT A SEVERELY CALCIFIED AND TORTUOUS LESION, WITH 70% STENOSIS, A LENGTH OF 8MM AND A DIAMETER OF 18MM LOCATED IN THE ESOPHAGUS. THE STRICTURE WAS BENT AT AN ANGLE GREATER THAN 46 DEGREE BUT LESS THAN 90 DEGREES. DURING THE PROCEDURE, AFTER DILATING THE LESION WITH A CRE BALLOON UNDER X-RAY, THE PHYSICIAN ADVANCED THE DEVICE TO THE TARGET AREA AND RELEASED THE STENT, HOWEVER, THE STENT WOULD NOT DETACH FROM THE DELIVERY SYSTEM. THE PHYSICIAN MOVED THE DELIVERY SYSTEM BUT THE STENT STILL WOULD NOT DETACH. FORCE WAS ENHANCED AND THE STENT WAS DEPLOYED COMPLETELY BUT NOT AT THE DESIRED SITE. AN X-RAY WAS PERFORMED TO CHECK THE STENT PLACEMENT AND, IT WAS CONFIRMED THAT THE STENT WAS NOT IN THE DESIRED LOCATION. THE PHYSICIAN REMOVED THE STENT FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER WALLFLEX ESOPHAGEAL STENT. 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 ESOPHAGEAL STENT WAS ATTEMPTED TO BE IMPLANTED IN THE ESOPHAGUS DURING AN ESOPHAGEAL STENT IMPLANTATION PROCEDURE PERFORMED ON (B)(6) 2014. ACCORDING TO THE COMPLAINANT, THE STENT WAS USED TO TREAT A SEVERELY CALCIFIED AND TORTUOUS LESION, WITH 70% STENOSIS, A LENGTH OF 8MM AND A DIAMETER OF 18MM LOCATED IN THE ESOPHAGUS. THE STRICTURE WAS BENT AT AN ANGLE GREATER THAN 46 DEGREE BUT LESS THAN 90 DEGREES. DURING THE PROCEDURE, AFTER DILATING THE LESION WITH A CRE BALLOON UNDER X-RAY, THE PHYSICIAN ADVANCED THE DEVICE TO THE TARGET AREA AND RELEASED THE STENT, HOWEVER, THE STENT WOULD NOT DETACH FROM THE DELIVERY SYSTEM. THE PHYSICIAN MOVED THE DELIVERY SYSTEM BUT THE STENT STILL WOULD NOT DETACH. FORCE WAS ENHANCED AND THE STENT WAS DEPLOYED COMPLETELY BUT NOT AT THE DESIRED SITE. AN X-RAY WAS PERFORMED TO CHECK THE STENT PLACEMENT AND, IT WAS CONFIRMED THAT THE STENT WAS NOT IN THE DESIRED LOCATION. THE PHYSICIAN REMOVED THE STENT FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER WALLFLEX ESOPHAGEAL STENT. 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
    357226 WALLFLEX? ESOPHAGEAL PROSTHESIS, ESOPHAGEAL ESW BOSTON SCIENTIFIC - MARLBOROUGH M00516920 15229171

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention