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

Model Number M00517820

Device Problem Activation Failure (3270)

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

Event Date 07/28/2023

Event Type  Injury  

Manufacturer Narrative

Block h6: imdrf device code a150101 captures the reportable event of stent failure to expand.

Event Description

It was reported to boston scientific corporation on (b)(6) 2023, that an agile esophageal otw stent was to be implanted in the esophagus to treat a 5cm stenosis during an esophageal stenting procedure performed on (b)(6), 2023.The patient's anatomy was not tortuous and was not dilated prior to stent placement.During the procedure, the stent was noted to have collapsed inside the patient's anatomy.The stent was removed using forceps, and a different stent was used to complete the procedure.There were no patient complications reported as a result of this event.Note: a photo of the complaint device was provided by the complainant and showed that the stent was fully deployed inside the patient.The stent appears to have collapsed and shaped like an hourglass.

Manufacturer Narrative

Block h6: imdrf device code a150101 captures the reportable event of stent failure to expand.Block h10: the agile esophageal fully covered rmv stent was received for analysis.The delivery system was not returned for analysis.Visual inspection found that the stent cover was damaged (holes), and the retention suture was detached from one of the flares.Media analysis of the photo provided found the stent was not fully expanded inside the patient's anatomy.No other damages were noted with the stent.Product analysis confirmed the reported event of stent failure to expand; as per media inspection, the stent did not fully expand inside the patient's anatomy.The additional investigation findings of stent cover damage and stent suture break were most likely due to procedural factors encountered during the procedure.It might be that the handling of the device, the technique used by the physician during the removal of the device with forceps limited the performance of the device and contributed to the observed failures.The investigation concluded that the reported event of stent failure to expand was due to anatomical factors.It is most likely that the patient's stenosis could have caused the stent not fully expand during the stent placement.Therefore, a review and analysis of all available information indicated that the most probable cause is adverse event related to patient condition.A product labeling review identified that the device was used per the instructions for use (ifu)/product label.

Event Description

It was reported to boston scientific corporation on (b)(6) 2023, that an agile esophageal otw stent was to be implanted in the esophagus to treat a 5cm stenosis during an esophageal stenting procedure performed on (b)(6) 2023.The patient's anatomy was not tortuous and was not dilated prior to stent placement.During the procedure, the stent was noted to have collapsed inside the patient's anatomy.The stent was removed using forceps, and a different stent was used to complete the procedure.There were no patient complications reported as a result of this event.Note: a photo of the complaint device was provided by the complainant and showed that the stent was fully deployed inside the patient.The stent appears to have collapsed and shaped like an hourglass.

• Brand Name: AGILE ESOPHAGEAL OTW
• 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: 17603531
• MDR Text Key: 321742471
• Report Number: 3005099803-2023-04512
• Device Sequence Number: 1
• Product Code: ESW
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: K211960
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/28/2023

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
• Device Operator: Health Professional
• Device Expiration Date: 03/01/2024
• Device Model Number: M00517820
• Device Catalogue Number: 1782
• Device Lot Number: 0028968102
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/02/2023
• Initial Date FDA Received: 08/23/2023
• Supplement Dates Manufacturer Received: 09/06/2023
• Supplement Dates FDA Received: 09/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/02/2022
• 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
• Patient Outcome(s): Required Intervention