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

Model Number	M00516730
Medical Device Problem Codes	Premature Activation (1484); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/23/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The initial reporter's facility name is institution dr (b)(6).Block h6: imdrf device code a150103 captures the reportable event of stent premature deployment.
Event or Problem Description
It was reported to boston scientific corporation that a wallflex esophageal fully covered stent was to be implanted to treat esophageal stenosis during a stent placement procedure performed on (b)(6) 2024.During the procedure, upon deploying the stent, it was noted that there was no mesh inside the delivery catheter.Subsequently, there was no prosthesis after the release process.There were no patient complications reported as a result of this event.Note: no further information has been obtained despite good faith efforts.
Additional Manufacturer Narrative
Block e1: the initial reporter's facility name is instituto dr (b)(6).The initial reporter's address is (b)(6).Block h6: imdrf device code a150103 captures the reportable event of stent premature deployment.Block h11: a wallflex esophageal delivery system was received for analysis; the stent was not returned.Visual inspection found that the outer clear and blue sheaths were kinked.Media inspection was performed on the photos provided and no problems were noted.No other problems were noted with the delivery system.Product analysis did not confirm the reported event of stent premature deployment.The observed events of outer clear sheath and outer blue sheath kinked were most likely due to procedural factors such as lesion characteristics, handling of the device, and the technique used by the physician (force applied).There is no indication on the reported event of stent premature deployment because the stent was not received, and this event occurred during the procedure and is not possible to replicate in the laboratory of analysis.Therefore, a review and analysis of all available information indicated the most probable cause is no problem detected.
Event or Problem Description
It was reported to boston scientific corporation that a wallflex esophageal fully covered stent was to be implanted to treat esophageal stenosis during a stent placement procedure performed on (b)(6) 2024.During the procedure, upon deploying the stent, it was noted that there was no mesh inside the delivery catheter.Subsequently, there was no prosthesis after the release process.There were no patient complications reported as a result of this event.Note: no further information has been obtained despite good faith efforts.

• 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: 19522752
• Report Number: 3005099803-2024-02785
• Device Sequence Number: 14960129
• Product Code: ESW
• UDI-Device Identifier: 08714729778066
• UDI-Public: 08714729778066
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/02/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/25/2025
• Device Model Number: M00516730
• Device Catalogue Number: 1673
• Device Lot Number: 0032703902
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/23/2024
• Supplement Date Received by Manufacturer: 11/08/2024
• Initial Report FDA Received Date: 06/12/2024
• Supplement Report FDA Received Date: 12/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/24/2023
• 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