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

Model Number	M00517730
Medical Device Problem Codes	Activation Failure (3270); Migration (4003)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/27/2024
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 manufacture and expiration dates are unknown.Block h6: imdrf device code a010402 captures the reportable event of stent migration imdrf device code a150101 captures the reportable event of stent failure to expand.Imdrf patient code e2401 captures the reportable event of patient not doing well.Imdrf impact code f2301 captures the reportable event of the physician then used a retrieval loop to pull the stent 5cm up towards the mouth.Imdrf impact code f2202 captures the reportable event of the stent was noted to have migrated and did not expand under endoscopic visualization.
Event or Problem Description
It was reported to boston scientific corporation that an agile esophageal partially covered otw stent was implanted to treat an esophageal cancer during a stent placement procedure performed on an (b)(6) 2024.During the procedure, the stent was able to be deployed.However, post stent placement, chest xray revealed that the stent had not fully expanded.The patient was not doing well and was brought back for emergent follow up.Under endoscopic visualization, it was noted that the stent had migrated and did not expand.The physician then used a retrieval loop to pull the stent 5cm up towards the mouth.The stent remains implanted, and the physician scheduled a removal or revision of the stent on (b)(6) 2024.A wallflex partially covered esophageal stent is scheduled to be placed.

• Brand Name: AGILE ESOPHAGEAL OTW
• 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: 20335992
• Report Number: 3005099803-2024-04717
• Device Sequence Number: 9603056
• Product Code: ESW
• UDI-Device Identifier: 00191506006600
• UDI-Public: 00191506006600
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K211960
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 09/30/2024

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: M00517730
• Device Catalogue Number: 1773
• 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: 09/03/2024
• Initial Report FDA Received Date: 09/30/2024
• 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