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

Model Number	M00516730
Medical Device Problem Codes	Difficult to Remove (1528); Positioning Problem (3009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/02/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block d4, h4: the complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.Block h6: imdrf device code a1502 captures the reportable event of stent positioning issue.Imdrf device code a150207 captures the reportable event of stent difficult to remove.Imdrf impact code f2202, and f2301 captures the additional procedure, "placement of feeding tube.".
Event or Problem Description
It was reported to boston scientific corporation that a wallflex esophageal fully covered stent was implanted to treat esophageal cancer during an esophageal stent placement procedure performed on (b)(6) 2024.The patient's anatomy was tortuous and had not been dilated prior to stent placement.During the procedure, the stent jumped upon deployment and moved into the stomach.The stent could not be removed from the patient and was left in the stomach.The procedure was rescheduled, and a feeding tube was placed.No patient complications were reported as a result of this event.Note: no further information has been obtained despite good faith efforts.
Additional Manufacturer Narrative
Blocks b5, and e1 (initial reporter's first and last name) have been updated with the additional information received on october 25, 2024.Block d4, h4: the complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.Block h6: imdrf device code a1502 captures the reportable event of stent positioning issue.Imdrf device code a150207 captures the reportable event of stent difficult to remove.Imdrf impact code f2202, and f2301 captures the additional procedure, "placement of feeding tube.".
Event or Problem Description
It was reported to boston scientific corporation that a wallflex esophageal fully covered stent was implanted to treat esophageal cancer during an esophageal stent placement procedure performed on (b)(6) 2024.The patient's anatomy was tortuous and had not been dilated prior to stent placement.During the procedure, the stent jumped upon deployment and moved into the stomach.The stent could not be removed from the patient and was left in the stomach.The procedure was rescheduled, and a feeding tube was placed.No patient complications were reported as a result of this event.Additional information was received on october 25, 2024.It was further report that the stent was placed during a distal esophageal stent placement procedure.The stent was unable to be removed due to the tightness of the structure.A rat tooth was used to push the stent into the stomach.

• 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: 20537438
• Report Number: 3005099803-2024-05409
• Device Sequence Number: 8284772
• Product Code: ESW
• UDI-Device Identifier: 08714729778066
• UDI-Public: 08714729778066
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K091510
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/19/2024

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 Model Number: M00516730
• Device Catalogue Number: 1673
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/02/2024
• Supplement Date Received by Manufacturer: 10/25/2024
• Initial Report FDA Received Date: 10/25/2024
• Supplement Report FDA Received Date: 11/19/2024
• 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