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

Model Number	M00516930
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/18/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to boston scientific corporation on (b)(6) 2023, that a wallflex esophageal partially covered stent was implanted in the esophagus to treat a malignant stricture during an esophageal stenting procedure performed on (b)(6) 2023.During a scheduled check per protocol post-stent placement, the stent was noted to have migrated into the stomach.The stent was removed from the patient using forceps, and a nasojejunal (nj) tube was placed to complete the procedure.There were no reported patient complications as a result of this event.
Additional Manufacturer Narrative
Imdrf device code a010402 captures the reportable event of stent migration.Impact code f2301 captures the used of additional device to remove the stent and the placement of a nasojejunal tube.

• 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: 16902461
• Report Number: 3005099803-2023-02523
• Device Sequence Number: 6847666
• Product Code: ESW
• UDI-Device Identifier: 08714729765271
• UDI-Public: 08714729765271
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: K073266
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/10/2023

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: 04/20/2024
• Device Model Number: M00516930
• Device Catalogue Number: 1693
• Device Lot Number: 0029260083
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/18/2023
• Initial Report FDA Received Date: 05/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/21/2022
• 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