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

Device Problems Break (1069); Off-Label Use (1494); Device-Device Incompatibility (2919); Positioning Problem (3009)

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

Event Date 03/01/2024

Event Type  Injury  

Manufacturer Narrative

Block b3: approximated based on the date the manufacturer became aware of the event.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 a1502 captures the reportable event of stent positioning issue.Imdrf device code a0401 captures the reportable event of stent suture break.

Event Description

It was reported to boston scientific corporation that an agile esophageal stent was to be implanted in the esophagus during an esophageal stent placement and suture stent fixation (overstitch) procedure performed on an unknown date.During the procedure, the stent was successfully deployed.However, the physician was not able to remove the scope and overstitch device due to the sutures being entangled.The scope was removed by pulling on both the overstitch suture and the stent purse string at which both sutures broke, which also caused the stent to be dislodged.The stent remains implanted, and the procedure was completed.There were no patient complications reported as a result of this event and the patient condition after the procedure was reported to be stable.Note: it was reported that during an esophageal stent placement procedure an agile stent and overstitch suture fixation device were to be used.However, per the agile esophageal 23mm otw project e0644, there is sufficient published evidence in the literature to support that the use of standard clips, endoscopic suturing, and over-the-scope clip decreases stent migration but does not eliminate it.

• 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: 19175078
• MDR Text Key: 340954597
• Report Number: 3005099803-2024-01739
• Device Sequence Number: 1
• Product Code: ESW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K211960
• 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
• Report Date: 04/24/2024

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/26/2024
• Initial Date FDA Received: 04/24/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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