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

Model Number	M00516940
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/17/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block h6: imdrf device code a0501 captures the reportable event of tip detachment.Imdrf patient code e2008 captures the device fragment inside the patient.
Event or Problem Description
It was reported to boston scientific corporation that a wallflex esophageal partially covered stent was implanted in the esophagus to treat a malignant stricture due to an esophageal tumor during the insertion of an esophageal stent procedure performed on (b)(6) 2024.The patient's anatomy was not tortuous and was dilated prior to stent placement.During the procedure, the stent was deployed successfully; however, it was noticed in the fluoroscopy that the olive tip separated from the delivery system.A gastroscope was inserted to attempt the removal of the detached olive tip, but it could not be removed.The detached olive tip was left in situ with the hope that it would dislodge on its own.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 detachment.Imdrf patient code e2008 captures the device fragment inside the patient.Block h11: the wallflex esophageal stent was not returned for analysis; therefore, a technical analysis could not be performed.However, media analysis was performed and found the detached tip was inside the patient.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 01 november 2023 through 25 january 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 01 november 2023 through 25 january 2024.Boston scientific also initiated a voluntary medical device removal of impacted batches (i.E., products manufactured between 01 november 2023 and 25 january 2024) of the wallflex esophageal stent system in august 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 partially covered stent was implanted in the esophagus to treat a malignant stricture due to an esophageal tumor during the insertion of an esophageal stent procedure performed on (b)(6) 2024.The patient's anatomy was not tortuous and was dilated prior to stent placement.During the procedure, the stent was deployed successfully; however, it was noticed in the fluoroscopy that the olive tip separated from the delivery system.A gastroscope was inserted to attempt the removal of the detached olive tip, but it could not be removed.The detached olive tip was left in situ with the hope that it would dislodge on its own.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: 19269916
• Report Number: 3005099803-2024-02119
• Device Sequence Number: 7411747
• Product Code: ESW
• UDI-Device Identifier: 08714729765288
• UDI-Public: 08714729765288
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K073266
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 09/05/2024

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: 12/01/2025
• Device Model Number: M00516940
• Device Catalogue Number: 1694
• Device Lot Number: 0032759900
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/17/2024
• Supplement Date Received by Manufacturer: 08/12/2024
• Initial Report FDA Received Date: 05/08/2024
• Supplement Report FDA Received Date: 09/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2023
• 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: FA 97244619
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown