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

Model Number M00517400

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Migration (4003)

Patient Problems Fistula (1862); Discomfort (2330)

Event Date 03/08/2021

Event Type  Injury  

Manufacturer Narrative

The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.However, the complainant reported that the device was not expired.(b)(4).The complainant indicated that the device was disposed and will not be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.

Event Description

It was reported to boston scientific corporation on (b)(6) 2021 that an agile esophageal fully covered stent was implanted to treat a less than 6cm malignant stricture in the esophagus during an esophagogastroduodenoscopy (egd) with stent placement procedure performed on (b)(6) 2020.Post-stent placement the patient underwent radiation.Reportedly, the patient's anatomy was tortuous and was not dilated prior to stent placement.On (b)(6) 2021, during emergent follow-up, the patient presented with tracheoesophageal fistula (tef) and discomfort.The tef started at the distal end of the stent.Consequently, the stent was removed from the patient using rat-tooth forceps and a non-bsc device was implanted over the tef to complete the procedure.In the physician's assessment the discomfort and the tef were related to the distal end of the stent and the radiation treatment.

Manufacturer Narrative

Block d4, h4: the complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.However, the complainant reported that the device was not expired.Block h6: patient code e2314 captures the reportable patient issue of a tracheoesophageal fistula.Patient code e2311 captures the reportable patient issue of discomfort.Impact code f2301 captures the additional intervention of stent removal during emergent follow-up and placement of a different device.Imdrf device code a010402 captures the reportable event of stent migration.

Event Description

It was reported to boston scientific corporation on march 15, 2021 that an agile esophageal fully covered stent was implanted to treat a less than 6cm malignant stricture in the esophagus during an esophagogastroduodenoscopy (egd) with stent placement procedure performed on (b)(6) 2020.Post-stent placement the patient underwent radiation.Reportedly, the patient's anatomy was tortuous and was not dilated prior to stent placement.On march 08, 2021, during emergent follow-up, the patient presented with tracheoesophageal fistula (tef) and discomfort.The tef started at the distal end of the stent.Consequently, the stent was removed from the patient using rat-tooth forceps and a non-bsc device was implanted over the tef to complete the procedure.In the physician's assessment the discomfort and the tef were related to the distal end of the stent and the radiation treatment.It was reported that an image showed that the agile esophageal stent migrated in the airway.

• 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: 11627301
• MDR Text Key: 246429741
• Report Number: 3005099803-2021-01521
• Device Sequence Number: 1
• Product Code: ESW
• UDI-Device Identifier: 08714729973027
• UDI-Public: 08714729973027
• 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,Followup
• Report Date: 02/28/2023

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
• Device Operator: Health Professional
• Device Model Number: M00517400
• Device Catalogue Number: 1740
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/15/2021
• Initial Date FDA Received: 04/07/2021
• Supplement Dates Manufacturer Received: 02/09/2023
• Supplement Dates FDA Received: 02/28/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Required Intervention