WallFlex™ Esophageal M00516910Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 08714729765257), received between Mar 28, 2017 and Mar 13, 2025 — classified as 10 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (5 reports).

1 FDA recall record name this device's identifier, 1 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Recalls naming this device

1. Aug 1, 2024Open, Classified

   WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment.

   Z-3282-2024 · Root cause: Process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• InjuryMar 13, 2025Positioning Failure; Detachment of Device or Device Component; Positioning Failure; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX ESOPHAGEAL STENT WAS IMPLANTED TO TREAT AN ESOPHAGEAL STENOSIS IN THE ESOPHAGUS DURING AN ESOPHAGEAL STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE CONICAL TIP OF THE STENT WAS DETACHED, RESULTING IN THE FAILURE OF SUBSEQUENT IMPLANTATION AND THE NEED FOR GASTROSCOPY TO REMOVE THE CONICAL TIP. THE PROCEDURE WAS NOT COMPLETE. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE. ADDITIONAL INFORMATION RECEIVED ON APRIL 23, 2025. IT WAS REPORTED THAT THE PROCEDURE WAS COMPLETED ON (B)(6) 2025, WITH A NON-BOSTON SCIENTIFIC DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21597184 ↗
• InjuryAug 22, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX ESOPHAGEAL PARTIALLY COVERED STENT WAS TO BE IMPLANTED IN THE ESOPHAGUS TO TREAT A CANCER DURING A STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2024. THE PATIENT'S ANATOMY WAS NOT TORTUOUS AND WAS NOT DILATED PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, THE TIP OF THE DEVICE GOT CAUGHT IN THE ESOPHAGEAL TISSUE. THE DEVICE WAS PULLED BACK; HOWEVER, THE TIP CAME OFF INTO THE ESOPHAGUS. THE DETACHED TIP WAS REMOVED USING RAT TOOTH FORCEPS, AND THE PROCEDURE WAS COMPLETED USING ANOTHER WALLFLEX ESOPHAGEAL STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20027611 ↗
• MalfunctionJun 18, 2024Material Deformation; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX PARTIALLY COVERED ESOPHAGEAL STENT WAS TO BE IMPLANTED DURING A STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, WHILE PLACING THE STENT, IT BECAME BENT. THERE ARE NO KNOWN PATIENT COMPLICATIONS DUE TO THIS EVENT. NOTE: NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19562857 ↗
• MalfunctionDec 26, 2023Positioning Failure; Detachment of Device or Device Component; Positioning Failure; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX ESOPHAGEAL PARTIALLY COVERED STENT WAS USED TO TREAT A MALIGNANT STRICTURE IN THE ESOPHAGUS DURING A STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2023. THE PATIENT'S ANATOMY WAS TORTUOUS AND WAS NOT DILATED PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, THE STENT WAS UNABLE TO BE DEPLOYED. THE HANDLE FELT FLIMSY AND THE WHITE OLIVE TIP WAS DETACHED FROM THE DELIVERY SYSTEM. THE STENT WAS FULLY COVERED BY THE OUTER SHEATH WHEN IT WAS REMOVED FROM THE PATIENT. THERE WAS NO ATTEMPT TO REMOVE THE TIP FROM THE PATIENT AND THE PHYSICIAN DECIDED TO LET THE TIP PASS OUT NATURALLY. THE PROCEDURE WAS COMPLETED WITH ANOTHER WALLFLEX ESOPHAGEAL STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18393344 ↗
• MalfunctionDec 16, 2022Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2022 THAT A WALLFLEX ESOPHAGEAL STENT WAS TO BE IMPLANTED IN THE ESOPHAGUS TO TREAT A 6CM MALIGNANT STRICTURE DUE TO ESOPHAGEAL CANCER DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) WITH STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2022. THE PATIENT ANATOMY WAS NOT DILATED PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, THE RO BAND MARKER WAS OBSERVED TO BE INCORRECTLY POSITIONED AND THE WALLFEX ESOPHAGEAL STENT (THE SUBJECT OF MFR. REPORT# 3005099803-2022-07566) WAS DEPLOYED PROXIMAL TO THE STRICTURE. THE WALLFLEX ESOPHAGEAL STENT WAS REMOVED FROM THE PATIENT WITH RAT-TOOTH COMBO FORCEPS. A SECOND WALLFLEX ESOPHAGEAL STENT (THE SUBJECT OF THIS REPORT) WAS OPENED, AND THE INNER STERILE POUCH WAS FOUND BROKEN. THE PROCEDURE WAS COMPLETED WITH A 3RD WALLFEX ESOPHAGEAL STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15999185 ↗
• MalfunctionJul 7, 2021Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2021 THAT A WALLFLEX ESOPHAGEAL PARTIALLY COVERED STENT WAS IMPLANTED FOR EXTRINSIC COMPRESSION OF THE ESOPHAGUS DURING AN ESOPHAGEAL STENTING PROCEDURE PERFORMED ON (B)(6), 2021. DURING THE PROCEDURE, THE PHYSICIAN USED A PARTIALLY COVERED STENT; HOWEVER, AFTER DEPLOYMENT, IT WAS NOTED THAT THE PROXIMAL PART OF THE STENT WAS COVERED. THE STENT REMAINS 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 GOOD. **REVIEW OF RECORD ON (B)(6) 2021** DURING THE PROCEDURE, THE STENT WAS INCORRECTLY LABELED. THE ORIGINAL STENT REMAINS IMPLANTED. NOTE: IT WAS REPORTED THAT THE LABEL INDICATED THE STENT WAS A PARTIALLY COVERED STENT WHICH IS SUPPOSED TO HAVE AN UNCOVERED PROXIMAL END; HOWEVER, THE PROXIMAL END OF THE STENT WAS COVERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12127309 ↗
• InjuryFeb 22, 2021Use of Device Problem; Failure to Advance; Detachment of Device or Device Component; Use of Device Problem; Failure to Advance; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2021 THAT A WALLFLEX ESOPHAGEAL PARTIALLY COVERED STENT WAS TO BE IMPLANTED TO TREAT AN ESOPHAGEAL STENOSIS DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) WITH ESOPHAGEAL STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2021. IT WAS REPORTED THAT DURING THE PROCEDURE, RESISTANCE WAS FELT AT THE PHARYNX WHEN ATTEMPTING TO PASS THE STENT ON A GUIDEWIRE. UNDER ENDOSCOPIC VISUALIZATION, IT WAS NOTED THAT THE SOFT TIP OF THE INTRODUCER WAS DETACHED. THE STENT WAS REMOVED FROM THE PATIENT WITH THE DELIVERY SYSTEM AND ANOTHER WALLFLEX ESOPHAGEAL STENT WAS IMPLANTED TO COMPLETE THE PROCEDURE. 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. IT WAS REPORTED THAT THE PATIENT'S ANATOMY WAS NOT TORTUOUS AND WAS NOT DILATED PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, THE STENT DID NOT REACH THE TARGET LESION IN THE ESOPHAGUS BECAUSE THE TIP DETACHED AT THE PHARYNX. IT WAS REPORTED THAT A 0.0035 JAGWIRE GUIDEWIRE WAS USED DURING THE ESOPHAGEAL STENT PLACEMENT PROCEDURE. NOTE: PER THE WALLFLEX ESOPHAGEAL PARTIALLY COVERED STENT SYSTEM

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11358824 ↗
• MalfunctionJun 11, 2020Positioning Failure; Failure to Advance; Material Integrity Problem; Positioning Failure; Failure to Advance; Material Integrity Problem

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT # 3005099803-2020-02157 FOR THE ASSOCIATED DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2020 THAT TWO WALLFLEX ESOPHAGEAL PARTIALLY COVERED STENTS WERE TO BE USED TO TREAT A 7CM EXTRINSIC STRICTURE IN THE LOWER ESOPHAGEAL SPHINCTER DURING A STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2020. REPORTEDLY, THE PATIENT'S ANATOMY WAS TORTUOUS AND WAS DILATED PRIOR TO STENT PLACEMENT. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE FIRST WALLFLEX ESOPHAGEAL STENT (THE SUBJECT OF THIS REPORT) HAD DIFFICULTY IN CROSSING THE ANATOMY AND WAS UNABLE TO BE DEPLOYED. UPON REMOVAL OF THE STENT DELIVERY SYSTEM, IT WAS NOTICED THAT THE WHITE OLIVE TIP WAS BENT. A SECOND WALLFLEX ESOPHAGEAL STENT (THE SUBJECT OF MFR. REPORT # 3005099803-2020-02157) WAS USED, HOWEVER, THE SAME ISSUES OCCURED AND THE WHITE OLIVE TIP WAS AGAIN BENT. REPORTEDLY, THE PHYSICIAN CALLED OFF ANY FURTHER TREATMENT. 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.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10143379 ↗
• InjuryJan 9, 2020Break; Difficult to Remove; Obstruction of Flow; Break; Difficult to Remove; Obstruction of Flow

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON DECEMBER 13, 2019 THAT A WALLFLEX ESOPHAGEAL PARTIALLY COVERED STENT WAS IMPLANTED TO TREAT A 1.5 CM DISTAL ESOPHAGEAL STRICTURE DURING AN ESOPHAGEAL STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2019. REPORTEDLY, THE PATIENT'S ANATOMY WAS NOT TORTUOUS AND WAS DILATED PRIOR TO STENT PLACEMENT. ADDITIONALLY 2-3 WEEKS LATER, THE PATIENT WANTED THE STENT REMOVED DUE TO SEVERE DISCOMFORT. ACCORDING TO THE COMPLAINANT, DURING THE STENT REMOVAL PROCEDURE, THE PHYSICIAN HAD DIFFICULTY REMOVING THE STENT FROM THE PATIENT DUE TO NORMAL TISSUE INGROWTH. REPORTEDLY, DURING THE ATTEMPT REMOVAL, THE STENT RETRIEVAL LOOP BROKE AND THE STENT WAS UNABLE TO BE REMOVED. THE PHYSICIAN PLACED A FULLY COVERED STENT WITHIN THE INITIAL STENT AND PLANNED TO REMOVE THE STENT FROM THE PATIENT IN A COUPLE OF WEEKS. ON (B)(6) 2019, THE STENT WAS SUCCESSFULLY REMOVED USING FORCEPS. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Discomfort; No Code Available

  MAUDE report 9572144 ↗
• InjuryApr 18, 2019Use of Device Problem; Migration; Use of Device Problem; Migration

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2019 THAT A WALLFLEX ESOPHAGEAL PARTIALLY COVERED STENT WAS IMPLANTED TO SEAL A PERFORATION IN THE DISTAL ESOPHAGUS DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) WITH STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, ON AN UNKNOWN DATE, THE STENT MIGRATED DISTALLY AND WAS CONFIRMED DURING AN IMAGING STUDY. REPORTEDLY, ON (B)(6) 2019 THE MIGRATED STENT WAS REMOVED ENDOSCOPICALLY AND WAS REPLACED WITH ANOTHER WALLFLEX ESOPHAGEAL STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NOTE: ACCORDING TO THE COMPLAINANT, THE WALLFLEX ESOPHAGEAL PARTIALLY COVERED STENT WAS PLACED TO SEAL A PERFORATION. HOWEVER, PER WALLFLEX ESOPHAGEAL PARTIALLY COVERED STENT SYSTEM DIRECTIONS FOR USE, THE STENT IS INDICATED FOR MAINTAINING ESOPHAGEAL LUMINAL PATENCY IN ESOPHAGEAL STRICTURES CAUSED BY INTRINSIC AND/OR EXTRINSIC MALIGNANT TUMORS, AND OCCLUSION OF CONCURRENT ESOPHAGEAL FISTULAS.

  Patient problems: No Code Available

  MAUDE report 8529115 ↗
• InjuryFeb 1, 2019Positioning Problem; Positioning Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON JANUARY 7, 2019 THAT A WALLFLEX ESOPHAGEAL PARTIALLY COVERED STENT WAS IMPLANTED TO TREAT A 6 CM MALIGNANT STRICTURE IN THE GASTROESOPHAGEAL JUNCTION DURING A STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2018. REPORTEDLY, THE PATIENT'S DISTAL ESOPHAGUS WAS TORTUOUS. ACCORDING TO THE COMPLAINANT, THE PATIENT PRESENTED BACK ON (B)(6) 2019 WITH PAIN FROM THE STENT. THE PHYSICIAN REPOSITIONED THE STENT TO HELP ELIMINATE DYSPHAGIA AND PAIN. ON (B)(6) 2019, THE STENT WAS REMOVED FROM THE PATIENT DURING AN ESOPHAGOGASTRODUODENOSCOPY PROCEDURE. REPORTEDLY, DYSPHAGIA AND PAIN WERE CONSIDERED RESOLVED. THE PATIENT'S CONDITION FOLLOWING THE PROCEDURE WAS REPORTED TO BE FINE. REPORTEDLY, THE PATIENT WILL CONTINUE THE CHEMOTHERAPY PER PROTOCOL.

  Patient problems: Dysphagia/ Odynophagia; Pain

  MAUDE report 8296801 ↗
• InjuryFeb 21, 2018Positioning Problem; Positioning Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2018 THAT A WALLFLEX ESOPHAGEAL PARTIALLY COVERED STENT WAS TO BE USED TO TREAT A 12CM MALIGNANT LESION DUE TO CANCER IN THE ESOPHAGUS DURING A STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2018. REPORTEDLY, THE PATIENT'S ANATOMY WAS NOT TORTUOUS. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE STENT WAS SUCCESSFULLY DEPLOYED. HOWEVER, THE PHYSICIAN WAS ABLE TO OBSERVE THROUGH THE SCOPE THAT THE STENT HAD MOVED OUT OF POSITION. IT WAS NOTED THAT THE DISTAL TIP OF THE STENT FAILED TO COVER THE LESION. THE PHYSICIAN REMOVED THE STENT USING FORCEPS AND PLANNED TO PERFORM ANOTHER STENT PLACEMENT PROCEDURE ON AN UNKNOWN DATE. 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.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7287349 ↗
• InjuryJan 3, 2018Break; Positioning Problem; Break; Positioning Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(4) 2017 THAT A WALLFLEX PARTIALLY COVERED ESOPHAGEAL STENT WAS IMPLANTED TO TREAT AN APPROXIMATELY 8CM ESOPHAGEAL MALIGNANT STRICTURE DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) WITH STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2017. REPORTEDLY, THE PATIENT'S ANATOMY WAS TIGHT AND WAS NOT DILATED PRIOR TO STENT PLACEMENT. ACCORDING TO THE COMPLAINANT, DURING PROCEDURE, THE PHYSICIAN MARKED THE STRICTURE SITE EXTERNALLY WITH MARKERS AND THE STENT WAS PLACED AT THE EXTERNAL MARKERS BUT MIGRATED DISTALLY AFTER DEPLOYMENT. THE PHYSICIAN ATTEMPTED TO REPOSITION THE STENT USING RAT TOOTH FORCEPS BUT THE SUTURE COULD NOT BE GRABBED DUE TO THE STRICTURE. A PEDIATRIC SCOPE AND PEDIATRIC BIOPSY FORCEPS WERE USED TO CAPTURE THE SUTURE. HOWEVER, AFTER THE SUTURE WAS GRABBED AND REPOSITION WAS ATTEMPTED, THE STENT SUTURE BROKE. THE PROCEDURE WAS COMPLETED BY IMPLANTING ANOTHER ESOPHAGEAL STENT TO BRIDGE THE STRICTURE SUCCESSFULLY. 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.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7160307 ↗
• InjuryMay 18, 2017Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON APRIL 28, 2017 THAT A WALLFLEX ESOPHAGEAL STENT WAS TO BE USED IN THE ESOPHAGUS DURING AN UNKNOWN PROCEDURE PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, A PART OF THE STENT GOT DETACHED BEFORE DEPLOYMENT AND WAS BLOCKING THE ESOPHAGUS. THE PATIENT WAS INTUBATED UNDER ANESTHESIA AND THE DETACHED PART WAS REMOVED. THE PROCEDURE WAS COMPLETED WITH ANOTHER WALLFLEX ESOPHAGEAL STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THIS EVENT HAVE BEEN UNSUCCESSFUL TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6577535 ↗
• InjuryMar 28, 2017Migration or Expulsion of Device; Migration or Expulsion of Device

  NOTE: THIS MANUFACTURER REPORT PERTAINS TO ONE OF TWO DEVICES USED IN THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT # 3005099803-2017-00856 AND 3005099803-2017-00972 FOR THE ASSOCIATED DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX PARTIALLY COVERED ESOPHAGEAL STENT AND A CRE WIREGUIDED BALLOON WERE USED IN A PATIENT WITH AN APPROXIMATELY 8CM LENGTH MALIGNANT LESION IN THE GASTRO ESOPHAGEAL JUNCTION DURING A GASTROSCOPY PROCEDURE IN THE DISTAL ESOPHAGUS PERFORMED ON (B)(6) 2017. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE STRICTURE WAS DILATED USING A CRE WIREGUIDED BALLOON (THE SUBJECT OF MFR REPORT# 3005099803-2017-00972) PRIOR TO STENT PLACEMENT AND A WALLFLEX PARTIALLY COVERED ESOPHAGEAL STENT (THE SUBJECT OF MFR REPORT# 3005099803-2017-00856) WAS IMPLANTED WITHOUT ISSUE. ON (B)(6) 2017, DURING AN X-RAY, THE WALLFLEX PARTIALLY COVERED ESOPHAGEAL STENT WAS NOTED TO HAVE MIGRATED DISTALLY IN THE ESOPHAGUS AND A PERFORATION WAS NOTED. THE STENT WAS REMOVED USING A SNARE AND A NEW WALLFLEX ESOPHAGEAL STENT WAS IMPLANTED, WHICH THE PHYSICIAN NOTED WAS ALSO TO TREAT THE PERFORATION. ACCORDING TO THE COMPLAINANT, IN THE PHYSICIAN¿S

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6440489 ↗