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

Model Number M00517770

Device Problems Difficult to Remove (1528); Use of Device Problem (1670)

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

Event Date 01/04/2023

Event Type  malfunction  

Manufacturer Narrative

Imdrf device code a150207 captures the reportable event of delivery system difficult to remove.

Event Description

Note: this report pertains to one of the two devices used on the same patient.Refer to manufacturer report number 3005099803-2023-00078 for the associated device information.It was reported to boston scientific corporation on (b)(6) 2023, that an agile esophageal otw fully covered stent was to be implanted in the esophagus to treat an esophageal tear during an esophagogastroduodenoscopy (egd) 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 agile esophageal otw fully covered stent (the subject of mfr.Report number 3005099803-2023-00078) was deployed using fluoroscopic imaging by pulling the distal catheter all the way to the proximal handle until it reached the target white radiopaque marker.During removal, technician was having difficulty removing the delivery catheter as two cells of the stent got stuck on the delivery catheter which caused the stent to be pulled together with the delivery catheter.A second agile esophageal otw fully covered stent (the subject of this report) was deployed; however, during the removal of the delivery system, the second agile esophageal stent was again got stuck in the delivery system.The technician waited for two minutes to allow the second agile esophageal stent to expand and then wiggled the catheter to disengage the stent from the delivery catheter.The procedure was cancelled despite the patient under general anesthesia because another agile esophageal stent was not available.On (b)(6) 2023, the patient was brought in for follow-up procedure.There were no patient complications reported as a result of this event.Note: it was reported that the agile esophageal otw fully covered stent was implanted in the lower esophagus to treat an esophageal tear.Per the agile esophageal fully covered otw stent system instructions for use (ifu), the stent 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 agile esophageal otw stent is not indicated for esophageal tear.It was reported that a 0.035mm bsc guidewire was used.However, per agile esophageal fully covered otw stent system instructions for use, a stiff bodied 0.038 in (0.97mm) guidewire with a floppy tip is recommended to facilitate passage through tortuous anatomy.The user did not use the required guidewire for the procedure.

• 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: 16227647
• MDR Text Key: 308014026
• Report Number: 3005099803-2023-00079
• Device Sequence Number: 1
• Product Code: ESW
• UDI-Device Identifier: 00191506006648
• UDI-Public: 00191506006648
• 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: 01/23/2023

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 Expiration Date: 04/04/2024
• Device Model Number: M00517770
• Device Catalogue Number: 1777
• Device Lot Number: 0029169175
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/04/2023
• Initial Date FDA Received: 01/23/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/05/2022
• 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 Age: 45 YR
• Patient Sex: Male
• Patient Weight: 91 KG