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

Model Number	M00516730
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Dysphagia/ Odynophagia (1815)
Date of Event	07/17/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block a2: patient's exact age is unknown; however, it was reported that the patient was over the age of 18.Blocks d4, h4: the complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.Block e1: the stent was repositioned by dr.(b)(6).Block h6: imdrf patient code e1009 captures the reportable event of dysphagia.Imdrf impact code f23 is being used to capture the additional intervention of repositioning the migrated stent.Imdrf device code a010402 captures the reportable event of stent migration.
Event or Problem Description
It was reported to boston scientific corporation that a wallflex esophageal fully covered stent was implanted in the esophagus to treat a malignant stricture during an upper gastrointestinal (gi) endoscopy with stent placement procedure performed on (b)(6) 2023.The patient's anatomy was tortuous and was dilated prior to stent placement procedure.On (b)(6) 2023, the patient presented with worsening dysphagia, which had started two weeks prior to the procedure.Upon checking, it was noted that the stent had distal partial migration due to stricture resolution.Subsequently, the stent was repositioned, and the procedure was completed.On (b)(6) 2023, the patient passed away.The clinical cause of the patient's death was a malignant esophageal neoplasm.

• 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: 18821342
• Report Number: 3005099803-2024-00792
• Device Sequence Number: 4499849
• Product Code: ESW
• UDI-Device Identifier: 08714729778066
• UDI-Public: 08714729778066
• Combination Product (Y/N): N
• Initial Reporter State: NH
• Initial Reporter Country: US
• PMA/510(K) Number: K091510
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/01/2024

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): Initial
• Initial Date Received by Manufacturer: 02/06/2024
• Initial Report FDA Received Date: 03/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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