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

Model Number	M00517470
Medical Device Problem Codes	Break (1069); Activation, Positioning or Separation Problem (2906); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/22/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block d4, h4: the complainant was unable to provide the suspect device lot number.Therefore, the manufacture and expiration dates are unknown.Block h6: imdrf device code a15 captures the reportable event of stent partially deployed.
Event or Problem Description
It was reported to boston scientific corporation that an agile esophageal tts fuly covered stent was to be implanted in the esophagus to treat a malignant stricture during an esophagogastroduodenoscopy (egd) with stent placement procedure performed on (b)(6) 2024.During the procedure, the sheath broke during attempted deployment.The stent was removed from the patient partially deployed and another agile esophageal stent was used to complete the procedure.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
Block d4, h4: the complainant was unable to provide the suspect device lot number.Therefore, the manufacture and expiration dates are unknown.Block h6: imdrf device code a15 captures the reportable event of stent partially deployed.Block h10: an agile esophageal stent and delivery system were received for analysis.Visual examination of the returned device found the stent partially deployed, the outer sheath detached and the inner sheath and stainless steel kinked.No other problems were noted to the stent and delivery system.The reported events of stent partially deployed and sheath break can be confirmed.Taking all available information into consideration, the investigation concluded that the reported events and the observed damages were likely due to factors encountered during the procedure.It may be that lesion characteristics, handling of the device and the technique used by the physician (force applied), limited the performance of the device and contributed to the reported events and observed damages.Therefore, a review and analysis of the all the available information indicated that the most probable cause is adverse event related to procedure.
Event or Problem Description
It was reported to boston scientific corporation that an agile esophageal tts fuly covered stent was to be implanted in the esophagus to treat a malignant stricture during an esophagogastroduodenoscopy (egd) with stent placement procedure performed on (b)(6) 2024.During the procedure, the sheath broke during attempted deployment.The stent was removed from the patient partially deployed and another agile esophageal stent was used to complete the procedure.There were no patient complications 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: 19089460
• Report Number: 3005099803-2024-01682
• Device Sequence Number: 7576262
• Product Code: ESW
• UDI-Device Identifier: 08714729973096
• UDI-Public: 08714729973096
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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,Followup
• Report Date (Section B): 05/24/2024

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 Model Number: M00517470
• Device Catalogue Number: 1747
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/10/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/22/2024
• Supplement Date Received by Manufacturer: 04/30/2024
• Initial Report FDA Received Date: 04/11/2024
• Supplement Report FDA Received Date: 05/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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