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

Model Number	M00516740
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/18/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block d4, h4: the complainant was unable to provide the suspect device lot number.Therefore, the manufacture and expiration dates are unknown.Block h6: imdrf device code: a0501 captures the reportable event of tip detachment of device or device component.
Event or Problem Description
It was reported to boston scientific corporation that a wallflex esophageal fully covered stent was to be implanted in the esophagus to treat an esophageal cancer during an egd (esophagogastroduodenoscopy) procedure performed on (b)(6), 2024.During the procedure, the white tip of the device was disconnected.The delivery system and tip were removed, and the procedure was completed using another wallflex esophageal stent.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Blocks d4 (lot number and expiration date), h4 (device manufacture date) were updated based on the additional information received on (b)(6), 2024.Block h6: imdrf device code a0501 captures the reportable event of tip detachment of device or device component.Block h10: a wallflex colonic stent was received for analysis.Visual examination of the returned device found the stent fully covered and the tip was not returned as it was detached.Additionally, the outer sheath was kinked, and the stainless steel handle was bent.No other damages were noted to the delivery system.The reported event of tip detachment of device or device component was confirmed as the device was returned without the tip.Taking all available information into consideration, the investigation concluded that the reported event and observed damages were likely due to factors encountered during the procedure.It is possible that the lesion characteristics, handling of the device, the technique used by the physician (force applied), limited the performance of the device and contributed to the reported event and observed problems.Therefore, the most probable cause of the reported event is adverse event related to procedure.
Event or Problem Description
It was reported to boston scientific corporation that a wallflex esophageal fully covered stent was to be implanted in the esophagus to treat an esophageal cancer during an egd (esophagogastroduodenoscopy) procedure performed on (b)(6), 2024.During the procedure, the white tip of the device was disconnected.The delivery system and tip were removed, and the procedure was completed using another wallflex esophageal stent.There were no patient complications reported as a result of this event.
Event or Problem Description
It was reported to boston scientific corporation that a wallflex esophageal fully covered stent was to be implanted in the esophagus to treat an esophageal cancer during an egd (esophagogastroduodenoscopy) procedure performed on (b)(6) 2024.During the procedure, the white tip of the device was disconnected.The delivery system and tip were removed, and the procedure was completed using another wallflex esophageal stent.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Blocks d4 (lot number and expiration date), h4 (device manufacture date) were updated based on the additional information received on april 23, 2024.Block h6: imdrf device code a0501 captures the reportable event of tip detachment of device or device component.Block h11: a wallflex esophageal stent was received for analysis.Visual examination of the returned device found the stent fully covered and the tip was not returned as it was detached.Additionally, the outer sheath was kinked, and the stainless steel handle was bent.No other damages were noted to the delivery system.The reported event of tip detachment of device or device component was confirmed as the device was returned without the tip.Taking all available information into consideration, the investigation concluded that the observed damages of outer clear sheath kinked and stainless steel handle bent were likely due to factors encountered during the procedure.It is possible that the lesion characteristics, handling of the device, the technique used by the physician (force applied), limited the performance of the device and contributed to the reported event and observed problems.The reported event of tip detached likely occurred due to factors encountered during the manufacturing process.Therefore, review and analysis of all available information indicated the most probable cause is manufacturing deficiency.A corrective and preventative action (capa) investigation was opened to further investigate these events and determine if corrective actions are warranted.

• 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: 19082251
• Report Number: 3005099803-2024-01511
• Device Sequence Number: 18200135
• Product Code: ESW
• UDI-Device Identifier: 08714729778073
• UDI-Public: 08714729778073
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/14/2025

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
• Operator of Device: Health Professional
• Device Expiration Date: 06/28/2025
• Device Model Number: M00516740
• Device Catalogue Number: 1674
• Device Lot Number: 0032927196
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/18/2024
• Supplement Date Received by Manufacturer: 04/23/2024; 12/23/2024
• Initial Report FDA Received Date: 04/10/2024
• Supplement Report FDA Received Date: 05/17/2024; 01/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/27/2023
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown