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

Model Number	M00517450
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Aspiration/Inhalation (1725); Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	04/12/2023
Type of Reportable Event	Death
Additional Manufacturer Narrative
Block h6: impact code f02 is being used to capture the reportable event of patient death.Imdrf patient code e0704 and e0506 are used to capture the reportable event of patient aspirated blood.
Event or Problem Description
It was reported to boston scientific corporation on april 13, 2023, that an agile esophageal tts fully covered stent was implanted in the esophagus to treat a 5 cm metastatic distal esophageal stricture during an esophagogastroduodenoscopy (egd) with stent placement procedure performed on (b)(6) 2023.A computerized tomography (ct) scan and magnetic resonance imaging (mri) were taken pre-procedure.During the procedure, the agile esophageal stent was successfully implanted.The patient was reported to be stable after the procedure.The patient reported that he was able to swallow and felt better post procedure and requested to have a drink.Patient was advised by the attending physician not to take any fluids post procedure to allow the stent to completely expand.At around 18:00, the patient was unable to breathe and was noted to have aspirated blood.A dnr (do not resuscitate) was in place.No further action was taken.Subsequently, the patient expired.

• 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: 16902272
• Report Number: 3005099803-2023-02527
• Device Sequence Number: 5459000
• 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
• 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): 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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 11/20/2024
• Device Model Number: M00517450
• Device Catalogue Number: 1745
• Device Lot Number: 0030573698
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/13/2023
• Initial Report FDA Received Date: 05/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/21/2022
• 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: Death
• Patient Sex: Male
• Patient Race: White