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

Model Number M00516730

Device Problems Use of Device Problem (1670); Detachment of Device or Device Component (2907); Material Deformation (2976)

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

Event Date 03/06/2024

Event Type  malfunction  

Manufacturer Narrative

Blocks d4, h4: the complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.Block h6: imdrf device code a0501 captures the reportable event of tip detached.

Event Description

It was reported to boston scientific corporation that a wallflex esophageal fully covered stent was used in the gastroesophageal junction to treat a post-surgical leak during an esophagogastroduodenoscopy (egd) with 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, while loading the stent over the guidewire, the white rubber cone at the end of the stent was detached.The procedure was completed with another wallflex esophageal stent.There were no patient complications reported as a result of this event.Note: it was reported that the wallflex esophageal stent was used to treat a post-surgical leak.However, per the wallflex esophageal fully covered stent system instructions for use (ifu), the stent is intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent esophageal fistulas.The device is not indicated for the treatment of leakage.

Event Description

It was reported to boston scientific corporation that a wallflex esophageal fully covered stent was used in the gastroesophageal junction to treat a post-surgical leak during an esophagogastroduodenoscopy (egd) with 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, while loading the stent over the guidewire, the white rubber cone at the end of the stent was detached.The procedure was completed with another wallflex esophageal stent.There were no patient complications reported as a result of this event.Note: it was reported that the wallflex esophageal stent was used to treat a post-surgical leak.However, per the wallflex esophageal fully covered stent system instructions for use (ifu), the stent is intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent esophageal fistulas.The device is not indicated for the treatment of leakage.

Manufacturer Narrative

Blocks d4, h4: the complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.Block h6: imdrf device code a0501 captures the reportable event of tip detached.Block h10: a wallflex esophageal fully covered stent and delivery system were received for analysis.The stent was received fully covered and undeployed.Visual inspection found the tip detached and was not returned.The outer sheath was kinked, and the stainless steel was bent.No other problems were noted with the stent and delivery system.Product analysis confirmed the reported event of tip detachment of device or device component.A product labeling review identified that the device was not used in accordance with the instructions for use (ifu) / product label.It was reported that the wallflex esophageal stent was used to treat a post-surgical leak.However, the ifu states, "the stent is intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent esophageal fistulas." it is most likely that procedural factors such as lesion characteristics, handling of the device, and the technique used by the physician (force applied) may have resulted in the reported event of tip detached and observed events of outer clear sheath kinked and stainless steel bent.Therefore, a review and analysis of all available information indicated 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: 18986098
• MDR Text Key: 338753642
• Report Number: 3005099803-2024-01249
• Device Sequence Number: 1
• Product Code: ESW
• UDI-Device Identifier: 08714729778066
• UDI-Public: 08714729778066
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K091510
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M00516730
• Device Catalogue Number: 1673
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/07/2024
• Initial Date FDA Received: 03/27/2024
• Supplement Dates Manufacturer Received: 05/03/2024
• Supplement Dates FDA Received: 05/22/2024
• Was Device Evaluated by Manufacturer?: Yes
• 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