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

Model Number M00517450

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Aspiration/Inhalation (1725); Hemorrhage/Bleeding (1888)

Event Date 04/12/2023

Event Type  Death  

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 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
• Type of Device: 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
• MDR Text Key: 314905715
• Report Number: 3005099803-2023-02527
• Device Sequence Number: 1
• Product Code: ESW
• UDI-Device Identifier: 08714729973072
• UDI-Public: 08714729973072
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K180144
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• 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
• Initial Date Manufacturer Received: 04/13/2023
• Initial Date FDA Received: 05/10/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/21/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Sex: Male
• Patient Race: White