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

Model Number	M00517450
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Dysphasia (2195)
Date of Event	05/18/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Medical device problem code (b)(4) captures the reportable event of stent migration.Impact code (b)(4) is being used to capture the additional intervention of egd procedure to remove the migrated stent.The complainant indicated that the device was disposed and will not be returned for evaluation; therefore, a problem analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.
Event or Problem Description
Iit was reported to boston scientific corporation on (b)(6) 2022 that an agile esophageal stent was implanted to treat a 2 cm malignant, tight, pinhole stricture in the mid esophagus due to an esophageal squamous cell carcinoma during an esophagogastroduodenoscopy (egd) procedure performed on (b)(6) 2022.On (b)(6) 2022, post stent placement, during a normal follow-up, the patient presented with dysphasia.Imaging was performed and showed the stent had migrated proximally above the stricture.Another egd procedure was performed, the stent was removed from the patient with rat tooth forceps and another wallflex esophageal stent was implanted to complete the procedure.There was no other intervention or treatment required to address the patient's dysphasia.There were no patient complications reported as a result of this event.

• Brand Name: AGILE 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: 14654762
• Report Number: 3005099803-2022-03116
• Device Sequence Number: 20044140
• Product Code: ESW
• UDI-Device Identifier: 08714729973072
• UDI-Public: 08714729973072
• Combination Product (Y/N): N
• Initial Reporter State: VT
• Initial Reporter Country: US
• PMA/510(K) Number: K180144
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• 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): 06/10/2022

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: 10/26/2023
• Device Model Number: M00517450
• Device Catalogue Number: 1745
• Device Lot Number: 0028267595
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/18/2022
• Initial Report FDA Received Date: 06/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/26/2021
• 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