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

Model Number M00516260

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

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

Event Date 12/29/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported to boston scientific corporation on (b)(6) 2023 that a wallflex fully covered esophageal rmv stent was used to treat a benign esophageal stricture during a stent placement procedure performed on (b)(6) 2022.The patient's anatomy prior to the lesion was not tortuous and was not dilated prior to stent placement.During the procedure, the device was advanced through the scope; however, prior to advancing the device through the lesion, the white tip got detached from the delivery system.Consequently, the white tip was removed with rescue forceps and another wallflex esophageal stent was used to complete the procedure.There were no patient complications reported as a result of this event.

Manufacturer Narrative

Block h6: imdrf device code a0501 captures the reportable event of tip detached.Block h10: a wallflex fully covered esophageal stent and delivery system were received for analysis.Visual inspection found the tip of the device detached and not returned.The outer clear sheath was kinked.Microscopic inspection found residues of adhesive to the inner sheath.No other issues were noted to the stent and delivery system.Product analysis confirmed the reported event of tip detachment of device or device component.It is most likely that procedural factors such as lesion characteristics, handling of the device, and the technique used by the physician during the procedure resulted to the reported event of tip detached and the observed event of outer clear sheath kinked.Therefore, a review and analysis of all available information indicated the most probable cause is adverse event related to procedure.A product labeling review identified that the device was used per the instructions for use (ifu) / product label.

Event Description

It was reported to boston scientific corporation on (b)(6) 2023 that a wallflex fully covered esophageal rmv stent was used to treat a benign esophageal stricture during a stent placement procedure performed on (b)(6) 2022.The patient's anatomy prior to the lesion was not tortuous and was not dilated prior to stent placement.During the procedure, the device was advanced through the scope; however, prior to advancing the device through the lesion, the white tip got detached from the delivery system.Consequently, the white tip was removed with rescue forceps and another wallflex esophageal stent was used to complete the procedure.There were no patient complications reported as a result of this event.

Event Description

It was reported to boston scientific corporation on january 18, 2023 that a wallflex fully covered esophageal rmv stent was used to treat a benign esophageal stricture during a stent placement procedure performed on (b)(6) 2022.The patient's anatomy prior to the lesion was not tortuous and was not dilated prior to stent placement.During the procedure, the device was advanced through the scope; however, prior to advancing the device through the lesion, the white tip got detached from the delivery system.Consequently, the white tip was removed with rescue forceps and another wallflex esophageal stent was used to complete the procedure.There were no patient complications reported as a result of this event.Update based on review on april 10, 2023: it was reported that the delivery system was advanced through the scope.However, per the wallflex esophageal fully covered rmv stent instructions for use (ifu), "after placing the guidewire, remove the endoscope from the patient leaving the guidewire in place.Reinsert the endoscope alongside the guidewire if direct visualization of stent deployment is desired." the device is not indicated to be placed through the working channel of a scope.

Manufacturer Narrative

Block h6: imdrf device code a0501 captures the reportable event of tip detached.Block h10: a wallflex fully covered esophageal stent and delivery system were received for analysis.Visual inspection found the tip of the device detached and not returned.The outer clear sheath was kinked.Microscopic inspection found residues of adhesive to the inner sheath.No other issues were noted to the stent and delivery system.Product analysis confirmed the reported event of tip detachment of device or device component.It is most likely that procedural factors such as lesion characteristics, handling of the device, and the technique used by the physician during the procedure resulted to the reported event of tip detached and the observed event of outer clear sheath kinked.Therefore, a review and analysis of all available information indicated the most probable cause is adverse event related to procedure.A product labeling review identified that the device was used per the instructions for use (ifu) / product label.

Manufacturer Narrative

Block h6: imdrf device code a0501 captures the reportable event of tip detached.Block h10: a wallflex fully covered esophageal stent and delivery system were received for analysis.Visual inspection found the tip of the device detached and not returned.The outer clear sheath was kinked.Microscopic inspection found residues of adhesive to the inner sheath.No other issues were noted to the stent and delivery system.Product analysis confirmed the reported event of tip detachment of device or device component.It is most likely that procedural factors such as lesion characteristics, handling of the device, and the technique used by the physician during the procedure resulted to the reported event of tip detached and the observed event of outer clear sheath kinked.Therefore, a review and analysis of all available information indicated the most probable cause is adverse event related to procedure.A product labeling review identified that the device was used in a manner inconsistent with the ifu (instructions for use) / product label.The ifu cited: "after placing the guidewire, remove the endoscope from the patient leaving the guidewire in place.Reinsert the endoscope alongside the guidewire if direct visualization of stent deployment is desired." the device is not indicated to be placed through the working channel of a scope.

Event Description

It was reported to boston scientific corporation on january 18, 2023 that a wallflex fully covered esophageal rmv stent was used to treat a benign esophageal stricture during a stent placement procedure performed on (b)(6), 2022.The patient's anatomy prior to the lesion was not tortuous and was not dilated prior to stent placement.During the procedure, the device was advanced through the scope; however, prior to advancing the device through the lesion, the white tip got detached from the delivery system.Consequently, the white tip was removed with rescue forceps and another wallflex esophageal stent was used to complete the procedure.There were no patient complications reported as a result of this event.Update based on review on april 10, 2023.It was reported that the delivery system was advanced through the scope.However, per the wallflex esophageal fully covered rmv stent instructions for use (ifu), "after placing the guidewire, remove the endoscope from the patient leaving the guidewire in place.Reinsert the endoscope alongside the guidewire if direct visualization of stent deployment is desired." the device is not indicated to be placed through the working channel of a scope.

• 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: 16316024
• MDR Text Key: 309007662
• Report Number: 3005099803-2023-00371
• Device Sequence Number: 1
• Product Code: ESW
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: SIMILAR
• 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,Followup
• Report Date: 05/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/14/2024
• Device Model Number: M00516260
• Device Catalogue Number: 1626
• Device Lot Number: 0030146718
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/18/2023
• Initial Date FDA Received: 02/07/2023
• Supplement Dates Manufacturer Received: 02/22/2023; 04/10/2023; 05/02/2023
• Supplement Dates FDA Received: 03/08/2023; 05/01/2023; 05/17/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/14/2022
• 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