BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WALLFLEX ESOPHAGEAL

    MDR report key: 22096003 · Received May 28, 2025

    Report

    Report Number
    3005099803-2025-02429
    Event Type
    Injury
    Date Received
    May 28, 2025
    Date of Event
    May 1, 2025
    Report Date
    July 10, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    ESW
    UDI-DI
    08714729854487
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCKS A3B (GENDER), B5, AND H6 (DEVICE CODES) HAVE BEEN CORRECTED. BLOCK E1: INITIAL REPORTER ADDRESS: (B)(6) ; REPORTED HERE AS THE FIRST NAME EXCEEDED CHARACTER LIMIT FOR THE DESIGNATED FIELD. BLOCK G4 : PREMARKET / 510(K)#: K233939; REPORTED HERE AS THE PREMARKET/510(K)# FIELD WAS NOT POPULATED. BLOCK H6: IMDRF DEVICE CODE A150103 CAPTURES THE REPORTABLE EVENT OF STENT PREMATURE DEPLOYMENT.

    Additional Manufacturer Narrative · 0

    BLOCK E1: INITIAL REPORTER ADDRESS: (B)(6); REPORTED HERE AS THE FIRST NAME EXCEEDED CHARACTER LIMIT FOR THE DESIGNATED FIELD. BLOCK G4: PREMARKET / 510(K)#: K233939; REPORTED HERE AS THE PREMARKET/510(K)# FIELD WAS NOT POPULATED. BLOCK H6: IMDRF DEVICE CODE A150103 CAPTURES THE REPORTABLE EVENT OF STENT PREMATURE DEPLOYMENT.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX ESOPHAGEAL STENT WAS TO BE IMPLANTED IN THE ESOPHAGOJEJUNAL ANASTOMOSIS TO TREAT A STENOSIS DURING AN ESOPHAGOGASTRODUODENOSCOPY PROCEDURE PERFORMED ON (B)(6) 2025. THE PATIENT'S ANATOMY WAS NON TORTUOUS AND WAS NOT DILATED PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, THE STENT WAS NOT SEEN INSIDE THE INTRODUCER, THE INTRODUCER WAS ADVANCED FURTHER MANAGING TO SEE THE YELLOW PART OF THE INTRODUCER. DESPITE MOBILIZING THE INTRODUCER AND THE ENDOSCOPE WAS NOT ABLE TO SEE THE STENT. THE INTRODUCER WAS REVERSED, AND THE ENDOSCOPE WAS ADVANCED, FINDING THAT THE STENT HAD BEEN RELEASED WITHOUT ACTIVATING THE INTRODUCER. THE PHYSICIAN ATTEMPTED TO REMOVE THE STENT BY PULLING IT BY THE SUTURE, BUT THE PROXIMAL CUP DID NOT COLLAPSE. AFTER MUCH DIFFICULTY IT WAS POSSIBLE TO REMOVE THE STENT FINDING THE DISTAL CUP COLLAPSED. THE STENT WAS THEN REMOVED WITH FORCEPS. THE PROCEDURE WAS COMPLETED USING ANOTHER OF THE SAME DEVICE. THERE WAS NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NOTE: IT WAS REPORTED THAT A WALLFLEX ESOPHAGEAL STENT WAS INTENDED TO BE PLACED DUE TO A STRICTURE IN THE ESOPHAGOJEJUNAL ANASTOMOSIS SITE. HOWEVER, PER THE WALLFLEX ESOPHAGEAL FULLY COVERED RMV STENT SYSTEM INSTRUCTION FOR USE, THE STENT IS INTENDED FOR MAINTAINING ESOPHAGEAL LUMINAL PATENCY IN ESOPHAGEAL STRICTURES CAUSED BY INTRINSIC AND/OR EXTRINSIC MALIGNANT TUMORS, OCCLUSION OF CONCURRENT ESOPHAGEAL FISTULAS AND TREATING REFRACTORY BENIGN ESOPHAGEAL STRICTURES. THE DEVICE IS NOT INDICATED TO BE PLACED DUE TO A STRICTURE IN THE ESOPHAGOJEJUNAL ANASTOMOSIS SITE.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX ESOPHAGEAL STENT WAS TO BE IMPLANTED IN THE ESOPHAGOJEJUNAL ANASTOMOSIS TO TREAT A STENOSIS DURING AN ESOPHAGOGASTRODUODENOSCOPY PROCEDURE PERFORMED ON (B)(6) 2025. THE PATIENT'S ANATOMY WAS NOT DILATED PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, THE STENT WAS NOT SEEN INSIDE THE INTRODUCER, THE INTRODUCER WAS ADVANCED FURTHER MANAGING TO SEE THE YELLOW PART OF THE INTRODUCER. DESPITE MOBILIZING THE INTRODUCER AND THE ENDOSCOPE WAS NOT ABLE TO SEE THE STENT. THE INTRODUCER WAS REVERSED, AND THE ENDOSCOPE WAS ADVANCED, FINDING THAT THE STENT HAD BEEN RELEASED WITHOUT ACTIVATING THE INTRODUCER. THE PHYSICIAN ATTEMPTED TO REMOVE THE STENT BY PULLING IT BY THE SUTURE, BUT THE PROXIMAL CUP DID NOT COLLAPSE. AFTER MUCH DIFFICULTY IT WAS POSSIBLE TO REMOVE THE STENT FINDING THE DISTAL CUP COLLAPSED. THE STENT WAS THEN REMOVED WITH FORCEPS. THE PROCEDURE WAS COMPLETED USING ANOTHER OF THE SAME DEVICE. THERE WAS NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1013272 WALLFLEX ESOPHAGEAL PROSTHESIS, ESOPHAGEAL ESW BOSTON SCIENTIFIC CORPORATION M00516220 0033704267 08714729854487

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention