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

Model Number M00517760

Device Problems Use of Device Problem (1670); Device-Device Incompatibility (2919); Positioning Problem (3009)

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

Event Date 03/08/2024

Event Type  Injury  

Manufacturer Narrative

Block a2: patient's exact age is unknown; however, it was reported that the patient was over the age of 18.Block h6: imdrf device code a1502 captures the reportable event of stent positioning issue.

Event Description

It was reported to boston scientific corporation that an agile esophageal otw fully covered stent was to be implanted in the esophagus to treat a 3cm malignant stricture during an upper gastrointestinal (gi) endoscopy with stent placement procedure performed on (b)(6) 2024.The patient's anatomy was tortuous and was not dilated prior to stent placement.During the procedure, the stent was deployed; however, it was moved out of its position as the needle driver of the apollo overstitch device became stuck in the stent during suture fixation.Subsequently, the stent was removed using forceps and a wallflex esophageal stent was used to complete the procedure.There were no patient complications reported as a result of this event.

Event Description

It was reported to boston scientific corporation that an agile esophageal otw fully covered stent was to be implanted in the esophagus to treat a 3cm malignant stricture during an upper gastrointestinal (gi) endoscopy with stent placement procedure performed on (b)(6) 2024.The patient's anatomy was tortuous and was not dilated prior to stent placement.During the procedure, the stent was deployed; however, it was moved out of its position as the needle driver of the apollo overstitch device became stuck in the stent during suture fixation.Subsequently, the stent was removed using forceps and a wallflex esophageal stent was used to complete the procedure.There were no patient complications reported as a result of this event.Update based on review on may 13, 2024: it was reported that during an upper gastrointestinal with stent placement procedure, an agile esophageal otw fully covered stent was to be implanted; however, an overstitch suture fixation device was also used, even though this technique is not indicated in the instructions for use (ifu).Per the agile esophageal 23mm otw project (b)(4), there is sufficient published evidence in the literature to support that the use of standard clips, endoscopic suturing, and over-the-scope clips decreases stent migration but does not eliminate it.

Manufacturer Narrative

Block a2: patient's exact age is unknown; however, it was reported that the patient was over the age of 18.Block h6: imdrf device code a1502 captures the reportable event of stent positioning issue.Block h11: correction to the initial mdr in blocks b5 and h6 (device codes).

• 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: 19075624
• MDR Text Key: 339776223
• Report Number: 3005099803-2024-01524
• 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,Followup
• Report Date: 05/29/2024

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
• Device Expiration Date: 05/30/2024
• Device Model Number: M00517760
• Device Catalogue Number: 1776
• Device Lot Number: 0029499270
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/18/2024
• Initial Date FDA Received: 04/09/2024
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/29/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/31/2022
• 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