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

Model Number M00517470

Device Problems Break (1069); Activation, Positioning or Separation Problem (2906); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/22/2024

Event Type  malfunction  

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 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.

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 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
• 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: 19089460
• MDR Text Key: 340237928
• Report Number: 3005099803-2024-01682
• Device Sequence Number: 1
• Product Code: ESW
• UDI-Device Identifier: 08714729973096
• UDI-Public: 08714729973096
• 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: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 03/22/2024
• Initial Date FDA Received: 04/11/2024
• Supplement Dates Manufacturer Received: 04/30/2024
• Supplement Dates FDA Received: 05/24/2024
• Was Device Evaluated by Manufacturer?: Yes
• 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