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

Model Number	M00517440
Medical Device Problem Codes	Difficult or Delayed Positioning (1157); Device-Device Incompatibility (2919); Positioning Problem (3009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/31/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to boston scientific corporation on (b)(6) 2023, that an agile esophageal fully covered stent was to be implanted in the distal esophagus to treat a 3cm malignant stricture during an esophagogastroduodenoscopy (egd) with stent placement procedure performed on (b)(6) 2023.The patient's anatomy was tortuous and was not dilated prior to stent placement.During the procedure, the stent was partially deployed on the delivery system when the handle was fully released.The physician assumed that the stent was fully deployed and attempted to remove the delivery system; consequently, the stent became stuck in the distal tip of the scope.The stent was able to be pushed out and was deployed in an incorrect location.The stent was removed with forceps and the procedure was completed with another agile stent of a different size.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: imdrf device code a1502 captures the reportable event of stent positioning issue.

• 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: 17596793
• Report Number: 3005099803-2023-04190
• Device Sequence Number: 17749950
• Product Code: ESW
• UDI-Device Identifier: 08714729973065
• UDI-Public: 08714729973065
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 08/22/2023

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: 01/10/2025
• Device Model Number: M00517440
• Device Catalogue Number: 1744
• Device Lot Number: 0030831551
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/31/2023
• Initial Report FDA Received Date: 08/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/11/2023
• 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
• Patient Sex: Unknown