MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION WALLFLEX ESOPHAGEAL; PROSTHESIS, ESOPHAGEAL

Model Number M00516920

Device Problems Use of Device Problem (1670); Activation, Positioning or Separation Problem (2906); Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/29/2023

Event Type  Injury  

Event Description

It was reported to boston scientific corporation on (b)(6) 2023, that a wallflex esophageal partially covered stent was to be implanted to treat an esophageal stenosis during an esophageal stenting procedure performed on april 29, 2023.During the procedure, the tip detached when the device was advanced through the esophagus.The device was removed from the patient and the procedure was not completed.There were no patient complications as a result of this event.A photo of the device provided by the complainant shows that the stent was partially deployed, and the tip was detached.

Manufacturer Narrative

Block h6: imdrf device code a0501 captures the reportable event of tip detached.Imdrf device code a15 captures the reportable event of stent partially deployed.

Manufacturer Narrative

Blocks b5, d7, e1, e2, e3, h6 (impact codes and device codes) and h8 have been updated with the additional information received on may 23, 2023, may 24, 2023, and may 29, 2023.Imdrf device code a0501 captures the reportable event of tip detached.Imdrf device code a15 captures the reportable event of stent partially deployed.

Event Description

It was reported to boston scientific corporation on april 29, 2023, that a wallflex esophageal partially covered stent was to be implanted to treat an esophageal stenosis during an esophageal stenting procedure performed on (b)(6) 2023.During the procedure, the tip detached when the device was advanced through the esophagus.The device was removed from the patient and the procedure was not completed.There were no patient complications as a result of this event.A photo of the device provided by the complainant shows that the stent was partially deployed, and the tip was detached.Additional information received on may 23, 2023, may 24, 2023, and may 29, 2023.It was reported that the wallflex esophageal partially covered stent was to be implanted to treat a benign esophageal stenosis.During the procedure, the tip detached inside the patient's upper esophageal sphincter.The tip was removed together with the sg dilator metal guidewire.The patient's anatomy was not tortuous and was not dilated prior to stent placement.Note: it was reported that the stent was attempted to be implanted to treat a benign esophageal stricture.However, per the 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.The stent is not indicated to be placed for a benign esophageal stricture.

Event Description

It was reported to boston scientific corporation on (b)(6) 2023, that a wallflex esophageal partially covered stent was to be implanted to treat an esophageal stenosis during an esophageal stenting procedure performed on (b)(6) 2023.During the procedure, the tip detached when the device was advanced through the esophagus.The device was removed from the patient and the procedure was not completed.There were no patient complications as a result of this event.A photo of the device provided by the complainant shows that the stent was partially deployed, and the tip was detached.Additional information received on may 23, 2023, may 24, 2023, and may 29, 2023: it was reported that the wallflex esophageal partially covered stent was to be implanted to treat a benign esophageal stenosis.During the procedure, the tip detached inside the patient's upper esophageal sphincter.The tip was removed together with the sg dilator metal guidewire.The patient's anatomy was not tortuous and was not dilated prior to stent placement.Note: it was reported that the stent was attempted to be implanted to treat a benign esophageal stricture.However, per the 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.The stent is not indicated to be placed for a benign esophageal stricture.

Manufacturer Narrative

Block h6: imdrf device code a0501 captures the reportable event of tip detached.Imdrf device code a15 captures the reportable event of stent partially deployed.Block h10: a wallflex esophageal stent and delivery system were received for analysis.Visual examination of the returned device found the stent fully deployed and expanded.The tip was detached and was not returned.The delivery system was also kinked in two sections and the outer sheath was buckled.Microscopic inspection was performed, and the inner sheath showed evidence of adhesive.A media inspection was performed of a photo provided by the complainant, and it was observed that the stent was partially deployed, and the tip was detached.No other problems were noted to the stent and delivery system.The reported events of stent partially deployed, and tip detached were confirmed.A labeling review was performed and from the information available, this device was used in a manner inconsistent per the instructions for use (ifu)/product label.The ifu states, "the wallflex esophageal partially covered stent system is indicated for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent esophageal fistulas." the stent is not indicated to be placed for a benign esophageal stricture.Taking all available information into consideration, the investigation concluded that the reported events and observed failures were likely due to factors encountered during the procedure.It may be that lesion characteristics, how the device was handled, and/or the technique used by the physician (force applied), limited the performance of the device and contributed to the reported events and observed failures.Therefore, a review and analysis of the all the available information indicated that the most probable cause is adverse event related to procedure.

• Brand Name: WALLFLEX ESOPHAGEAL
• Type of Device: PROSTHESIS, ESOPHAGEAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 16984404
• MDR Text Key: 315760496
• Report Number: 3005099803-2023-02630
• Device Sequence Number: 1
• Product Code: ESW
• UDI-Device Identifier: 08714729765264
• UDI-Public: 08714729765264
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K073266
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 10/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/20/2023
• Device Model Number: M00516920
• Device Catalogue Number: 56453
• Device Lot Number: 0027347666
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/02/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/20/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 55 YR
• Patient Sex: Male