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

Model Number	M00516710
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Positioning Problem (3009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/23/2024
Type of Reportable Event	Serious Injury
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 a malignant stricture during an esophagogastroduodenoscopy procedure performed on (b)(6) 2024.The patient's anatomy was not tortuous and was not dilated prior to stent placement.During the procedure, the stent was attempted to be deployed.However, the tip was noted to be detached inside the patient under fluoroscopy, and the stent was moved out of its position.The detached tip was removed using forceps.The stent was removed from the patient and the procedure was not completed.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 of device or device component.Imdrf device code a1502 captures the reportable event of stent positioning issue.
Additional Manufacturer Narrative
Block b5 was updated based on the additional information received on june 18, 2024.Block h6: imdrf device code a0501 captures the reportable event of tip detachment of device or device component.Imdrf device code a1502 captures the reportable event of stent positioning issue.
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 a malignant stricture during an esophagogastroduodenoscopy procedure performed on (b)(6) 2024.The patient's anatomy was not tortuous and was not dilated prior to stent placement.During the procedure, the stent was attempted to be deployed.However, the tip was noted to be detached inside the patient under fluoroscopy, and the stent was moved out of its position.The detached tip was removed using forceps.The stent was removed from the patient and the procedure was not completed.There were no patient complications reported as a result of this event.Additional information received on june 18, 2024.It was reported that the procedure was not completed due to no other device was available.
Additional Manufacturer Narrative
Block h6: imdrf device code a0501 captures the reportable event of tip detachment of device or device component.Imdrf device code a1502 captures the reportable event of stent positioning issue.Blocks h6 (evaluation conclusion codes), h7, and h9 were updated based on investigation findings that the complaint is part of the field action.
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 a malignant stricture during an esophagogastroduodenoscopy procedure performed on april 23, 2024.The patient's anatomy was not tortuous and was not dilated prior to stent placement.During the procedure, the stent was attempted to be deployed.However, the tip was noted to be detached inside the patient under fluoroscopy, and the stent was moved out of its position.The detached tip was removed using forceps.The stent was removed from the patient and the procedure was not completed.There were no patient complications reported as a result of this event.***additional information received on june 18, 2024*** it was reported that the procedure was not completed due to no other device was available.

• 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: 19341059
• Report Number: 3005099803-2024-02268
• Device Sequence Number: 8739998
• Product Code: ESW
• UDI-Device Identifier: 08714729778042
• UDI-Public: 08714729778042
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/22/2024

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: 07/12/2025
• Device Model Number: M00516710
• Device Catalogue Number: 1671
• Device Lot Number: 0033030432
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/24/2024
• Supplement Date Received by Manufacturer: 06/18/2024; 09/30/2024
• Initial Report FDA Received Date: 05/17/2024
• Supplement Report FDA Received Date: 07/12/2024; 10/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/11/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown