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

Model Number	M00517440
Medical Device Problem Codes	Use of Device Problem (1670); Positioning Problem (3009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/28/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.(b)(4).
Event or Problem Description
It was reported to boston scientific corporation on (b)(6) 2022, that an agile esophageal fully covered stent was to be implanted to treat a 2cm benign anastomotic stricture during a stent placement procedure performed on (b)(6) 2022.The patient's anatomy was dilated prior to stent placement.During the procedure, the agile stent was being advanced in a "bend" stricture as a result of surgical resection.When the agile stent was attempted to be pulled up 1cm proximally, the stent "jumped" pulling the bottom portion of the agile stent and the agile stent was consequently deployed above the stricture.The agile esophageal stent was removed with standard forceps and the procedure was cancelled due to another of the same device was unavailable.However, this time, the physician is going to use a 10cm agile esophageal stent instead of a 6cm agile esophageal stent due to the location of the stricture.There were no patient complications reported as a result of this event.Note: it was reported that the agile esophageal stent was to be implanted to treat a 2cm benign stricture.Per the instructions for use (ifu), "the agile esophageal fully covered stent system is intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent esophageal fistulas".The stent is not indicated for the treatment of benign stricture.

• 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: 15614287
• Report Number: 3005099803-2022-06109
• Device Sequence Number: 5983286
• Product Code: ESW
• UDI-Device Identifier: 08714729973065
• UDI-Public: 08714729973065
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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): 10/17/2022

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 Model Number: M00517440
• Device Catalogue Number: 1744
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/28/2022
• Initial Report FDA Received Date: 10/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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