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

Model Number	M00516730
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/03/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block h6: imdrf device code a0501 captures the reportable event of tip detached.
Event or Problem Description
It was reported to boston scientific corporation that a wallflex esophageal fully covered stent was used to treat an anastomotic leak in the esophagus, mid-distal at the anastomotic site during an esophagogastroduodenoscopy (egd) with esophageal stent placement procedure performed on (b)(6) 2024.A portion of the patient's anatomy was tortuous, although not severely, and was not dilated prior to stent placement.During the procedure, the physician encountered resistance while advancing the device over the guidewire.Fluoroscopy revealed that the distal tip had detach from the delivery system.Consequently, the stent was removed, and the detached tip was also successfully removed using retrieval forceps.The procedure was completed with another of the same device.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: imdrf device code a0501 captures the reportable event of tip detached.Block h11: a wallflex esophageal fully covered stent was returned for analysis.The stent was returned fully covered and undeployed, and the tip was not returned; it was detached.Visual examination of the returned delivery system found the outer sheath kinked.Functional examination was performed, and the guidewire could advance without any problems.No other damages were noted to the stent and the delivery system.Product analysis confirmed the reported event of tip detached as the tip was not returned, it was detached.Functional inspection confirmed the guidewire could advance without any issues/problems.Taking all available information into consideration, the overall root cause of the reported event is manufacturing deficiency in (b)(6) 2024, boston scientific initiated a non-conforming events prevention (ncep) investigation to further analyze an increase in "tip detachment of device or device component" complaints associated with the wallflex esophageal stents product family.The investigation found that the observed increase in complaints included devices manufactured from (b)(6) 2023 through (b)(6) 2024.A comprehensive review of the manufacturing process was conducted as part of the investigation to determine if factors within the manufacturing process (i.E., process changes, maintenance routines, calibration activity, materials, personnel, environment, and manufacturing work instructions) could have contributed to overall tip adhesion performance.Although a definitive root cause was not identified, overall manufacturing variation was reduced by modifying maintenance routines associated with process inputs (pad change in tip bond fixture), implementing a material change (glue), and reinforcing training/review of manufacturing work instructions.As a result of this investigation, boston scientific placed a ship hold on all impacted wallflex esophageal stent system products manufactured from (b)(6) 2023 through (b)(6) 2024.Boston scientific also initiated a voluntary medical device removal of impacted batches (i.E., products manufactured between (b)(6) 2023 and (b)(6) 2024) of the wallflex esophageal stent system in (b)(6) 2024 (boston scientific ref.(b)(4)).A corrective and preventative action (capa) investigation has been opened to further investigate these events and determine if additional corrective actions are warranted to further enhance/optimize product performance.This investigation is currently in process.
Event or Problem Description
It was reported to boston scientific corporation that a wallflex esophageal fully covered stent was used to treat an anastomotic leak in the esophagus, mid-distal at the anastomotic site during an esophagogastroduodenoscopy (egd) with esophageal stent placement procedure performed on (b)(6) 2024.A portion of the patient's anatomy was tortuous, although not severely, and was not dilated prior to stent placement.During the procedure, the physician encountered resistance while advancing the device over the guidewire.Fluoroscopy revealed that the distal tip had detach from the delivery system.Consequently, the stent was removed, and the detached tip was also successfully removed using retrieval forceps.The procedure was completed with another of the same device.There were no patient complications reported as a result of this event.

• Brand Name: WALLFLEX ESOPHAGEAL
• Common Device Name: 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: 19868399
• Report Number: 3005099803-2024-03410
• Device Sequence Number: 15110049
• Product Code: ESW
• UDI-Device Identifier: 08714729778066
• UDI-Public: 08714729778066
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: K091510
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 10/03/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 07/16/2025
• Device Model Number: M00516730
• Device Catalogue Number: 1673
• Device Lot Number: 0033064555
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/04/2024
• Supplement Date Received by Manufacturer: 09/05/2024
• Initial Report FDA Received Date: 07/30/2024
• Supplement Report FDA Received Date: 10/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/15/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 97244619-FA
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male