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

Model Number	M00517760
Medical Device Problem Codes	Difficult or Delayed Positioning (1157); Positioning Problem (3009); Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/16/2022
Type of Reportable Event	Serious Injury
Event or Problem 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.
Additional 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
• Common Device Name: 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
• Report Number: 3005099803-2022-01755
• Device Sequence Number: 11405861
• Product Code: ESW
• UDI-Device Identifier: 00191506006631
• UDI-Public: 00191506006631
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K211960
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: 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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/16/2022
• Initial Report FDA Received Date: 04/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/25/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown