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

Model Number	M00517450
Medical Device Problem Codes	Difficult to Remove (1528); Positioning Problem (3009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/18/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).(b)(4).
Event or Problem Description
It was reported to boston scientific corporation on (b)(6) 2022 that an agile esophageal stent was to be implanted in the esophagus to treat an approximately 4-5 cm esophageal tumor during an esophagogastroduodenoscopy (egd) procedure performed on (b)(6) 2022.The patient's anatomy was not tortuous and was not dilated prior to stent placement.During the procedure, the agile esophageal stent was successfully deployed under fluoroscopic guide.Upon removal of the agile delivery system, the stent suture loop got caught on the delivery system and the agile esophageal stent moved out from the target location.The agile esophageal stent was removed together with the delivery system through the patient's mouth.The procedure was completed with another agile esophageal stent.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: 15384976
• Report Number: 3005099803-2022-05116
• Device Sequence Number: 5613886
• Product Code: ESW
• UDI-Device Identifier: 08714729973072
• UDI-Public: 08714729973072
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K180144
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/13/2024
• Device Model Number: M00517450
• Device Catalogue Number: 1745
• Device Lot Number: 0029225826
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/18/2022
• Initial Report FDA Received Date: 09/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/14/2022
• 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
• Patient Sex: Unknown