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

Model Number M00517760

Device Problems Difficult or Delayed Positioning (1157); Positioning Problem (3009); Migration (4003)

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

Event Date 03/16/2022

Event Type  Injury  

Event Description

It was reported to boston scientific corporation on (b)(6)2022 that an agile esophageal otw fully covered stent was implanted to treat a 5cm malignant stricture in the distal esophagus during an esophagogastroduodenoscopy (egd) with stent placement procedure performed on (b)(6)2022.Reportedly, the patient's anatomy was tortuous and was dilated prior to stent placement.During the procedure, the stent was difficult to deploy and was fully deployed more distal.The stent was successfully repositioned into its correct position with forceps and the procedure was completed.However, a day after stent placement, it was noted that the stent migrated into the stomach.The stent was removed and a competitor's percutaneous endoscopic gastrostomy (peg) tube and a replacement gastrostomy tube were placed for palliative care.There were no patient complications reported as a result of this event.In the physician's assessment, the patient's anatomy and progression of disease state contributed to the difficult deployment.In the physician's assessment, the stent migrated due to the stent dilating the stricture.

Manufacturer Narrative

(b)(4).The complainant indicated that the device was disposed and will not be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.

• 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: 14025129
• MDR Text Key: 288701642
• Report Number: 3005099803-2022-01755
• Device Sequence Number: 1
• Product Code: ESW
• UDI-Device Identifier: 00191506006631
• UDI-Public: 00191506006631
• 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: 04/06/2022

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: 02/25/2024
• Device Model Number: M00517760
• Device Catalogue Number: 1776
• Device Lot Number: 0028938651
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/16/2022
• Initial Date FDA Received: 04/06/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/25/2022
• 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