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

Model Number	M00517780
Medical Device Problem Codes	Use of Device Problem (1670); Migration (4003)
Health Effect - Clinical Codes	Abdominal Pain (1685); Dysphagia/ Odynophagia (1815); Vomiting (2144)
Date of Event	02/09/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block a2: the patient was born in 1960.Block a4: the patient's weight is 104.3 kg.Block e1: the stent was repositioned and removed by dr.(b)(6).Block h6: imdrf device code a010402 captures the reportable event of stent migration.Imdrf impact code f23 captures the additional intervention of stent repositioning and suturing.Imdrf impact code f2301 captures the use of graspers to remove the stent.
Event or Problem Description
It was reported to boston scientific corporation that an agile esophageal otw fully covered stent was implanted to treat a 1.1cm x 15cm malignant stenosis during an esophagogastroduodenoscopy (egd) with stent placement procedure performed on (b)(6) 2024.Post-stent placement, on (b)(6) 2024, the patient presented to the emergency department with dysphagia, middle to left upper abdominal pain, and vomiting.It was then noted that the stent had completely migrated proximal to the stomach.The stent was repositioned and sutured to secure its position in the esophagus.However, on (b)(6) 2024, the patient returned to the emergency department with the same symptoms.Consequently, the stent was removed with graspers and the procedure was completed.Note: it was reported that an agile esophageal otw fully covered stent was sutured to secure its position.Per the agile esophageal 23mm otw project e0644, 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.

• 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: 19480735
• Report Number: 3005099803-2024-02607
• Device Sequence Number: 15488668
• Product Code: ESW
• UDI-Device Identifier: 00191506006655
• UDI-Public: 00191506006655
• Combination Product (Y/N): N
• Initial Reporter State: NH
• Initial Reporter Country: US
• PMA/510(K) Number: K211960
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/06/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/12/2024
• Device Model Number: M00517780
• Device Catalogue Number: 1778
• Device Lot Number: 0030136290
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/13/2024
• Initial Report FDA Received Date: 06/06/2024
• Date Device Manufactured: 09/13/2022
• 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 Age: 63 YR
• Patient Sex: Male
• Patient Race: White