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

Device Problems Difficult to Remove (1528); Use of Device Problem (1670); Material Deformation (2976)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 12/08/2023

Event Type  Injury  

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 a150207 captures the reportable event of delivery system difficult to remove.Imdrf patient code e0506 captures the reportable event of major hemorrhage.Imdrf impact code f19 captures the reportable event of patient was sent to surgery.

Event Description

It was reported to boston scientific corporation that an agile biliary stent was to be implanted to treat emergent bleeding that was coming through a fistulous cavity possibly due to a splenic artery pseudoaneurysm during a procedure performed on (b)(6), 2023.The patient's anatomy was extremely tortuous.During the procedure, the stent delivery system got stuck on the proximal flange of the stent.The physician attempted to wiggle the catheter, however, the stent suture got caught on the catheter and the delivery system could not be removed.The stent delivery system was eventually removed.The patient was sent to surgery to treat the emergent bleeding.Note: it was reported that the agile stent was attempted to be implanted to treat a bleeding.However, per the agile esophageal partially covered and fully covered stent systems directions for use, the stent is indicated for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent esophageal fistula.The device is not indicated for bleeding.

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 b5 was updated based on the additional information received on december 28, 2023.Block h6: imdrf device code a150207 captures the reportable event of delivery system difficult to remove.Imdrf patient code e0506 captures the reportable event of major hemorrhage.Imdrf impact code f19 captures the reportable event of patient was sent to surgery.

Event Description

It was reported to boston scientific corporation that an agile biliary stent was to be implanted to treat emergent bleeding that was coming through a fistulous cavity possibly due to a splenic artery pseudoaneurysm during a procedure performed on (b)(6) 2023.The patient's anatomy was extremely tortuous.During the procedure, the stent delivery system got stuck on the proximal flange of the stent.The physician attempted to wiggle the catheter, however, the stent suture got caught on the catheter and the delivery system could not be removed.The stent delivery system was eventually removed.The patient was sent to surgery to treat the emergent bleeding.Note: it was reported that the agile stent was attempted to be implanted to treat a bleeding.However, per the agile esophageal partially covered and fully covered stent systems directions for use, the stent is indicated for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent esophageal fistula.The device is not indicated for bleeding.The stent was to be implanted in the gastroesophageal (ge) junction.It was reported that there was no altered anatomy from gastric bypass and gastric sleeve.The emergency surgery was performed on the same day the agile stent was attempted to be implanted and the patient was reported to have recovered from the blood loss.

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 a150207 captures the reportable event of delivery system difficult to remove.Imdrf patient code e0506 captures the reportable event of major hemorrhage.Imdrf impact code f19 captures the reportable event of patient was sent to surgery.Block h11: block b5 has been corrected.

Event Description

It was reported to boston scientific corporation that an agile esophageal stent was to be implanted to treat emergent bleeding that was coming through a fistulous cavity possibly due to a splenic artery pseudoaneurysm during a procedure performed on (b)(6) 2023.The patient's anatomy was extremely tortuous.During the procedure, the stent delivery system got stuck on the proximal flange of the stent.The physician attempted to wiggle the catheter, however, the stent suture got caught on the catheter and the delivery system could not be removed.The stent delivery system was eventually removed.The patient was sent to surgery to treat the emergent bleeding.Note: it was reported that the agile stent was attempted to be implanted to treat a bleeding.However, per the agile esophageal partially covered and fully covered stent systems directions for use, the stent is indicated for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent esophageal fistula.The device is not indicated for bleeding.Additional information received on december 28, 2023: the stent was to be implanted in the gastroesophageal (ge) junction.There was no malignance, however, the patient had altered anatomy due to the reversal of gastric bypass & gastric sleeve procedures.The emergency surgery was performed on the same day the agile stent was attempted to be implanted and the patient was reported to have recovered from the blood loss.

• 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: 18438449
• MDR Text Key: 331831300
• Report Number: 3005099803-2023-06945
• 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,Followup
• Report Date: 04/08/2024

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: 12/08/2023
• Initial Date FDA Received: 01/03/2024
• Supplement Dates Manufacturer Received: 12/28/2023; 03/25/2024
• Supplement Dates FDA Received: 01/19/2024; 04/08/2024
• 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
• Patient Sex: Female