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

Model Number	M00517450
Medical Device Problem Codes	Use of Device Problem (1670); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Erosion (1750); Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	09/30/2023
Type of Reportable Event	Death
Additional Manufacturer Narrative
Block h6: imdrf patient code e2006 captures the reportable event of erosion.Imdrf patient code e0506 captures the reportable events of hemorrhage, major and blood loss.Imdrf impact code f2303 captures the administration of epinephrine to address the bleeding.Imdrf impact code f08 captures the patient's hospitalization due to bleeding.Imdrf impact code f23 captures the removal of the stent.Imdrf impact code f02 captures the reportable event of death.
Event or Problem Description
It was reported to boston scientific corporation that an agile esophageal fully covered stent was implanted in the esophagus to treat a benign stricture during an esophagogastroduodenoscopy (egd) with stent placement procedure performed on (b)(6) 2023.The patient's anatomy was tortuous.On (b)(6) 2023, during emergent follow-up, the patient presented with bleeding around the distal flange of the stent.The physician believed that the distal flange of the stent eroded the mucosa which resulted in bleeding requiring hospitalization.Subsequently, the stent was removed, and epinephrine was administered to stop the bleeding.Later that day, recurrence of bleeding occurred; however, the patient refused additional care.On the same date, the patient passed away due to blood loss.In the physician's assessment, the relationship between the stent and the patient's death is unknown.Note: it was reported that the agile esophageal stent was implanted to treat a benign stricture.However, per the agile esophageal fully covered stent system instructions for use (ifu), the stent is intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent esophageal fistulas.The device is not indicated for the treatment of a benign stricture.

• 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: 18004270
• Report Number: 3005099803-2023-05732
• Device Sequence Number: 6643378
• Product Code: ESW
• UDI-Device Identifier: 08714729973072
• UDI-Public: 08714729973072
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K180144
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/25/2023

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: 05/09/2025
• Device Model Number: M00517450
• Device Catalogue Number: 1745
• Device Lot Number: 0031587899
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/04/2023
• Initial Report FDA Received Date: 10/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/10/2023
• 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; Hospitalization; Death
• Patient Sex: Female