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

Model Number	M00517770
Medical Device Problem Codes	Use of Device Problem (1670); Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/17/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
Note: this report pertains to one of the two devices used on the same patient.Refer to manufacturer report# 3005099803-2022-07928 for the associated device information.It was reported to boston scientific corporation on december 29, 2022, that an agile esophageal otw fully covered stent was implanted in the lower esophagus to treat a perforation during an esophagogastroduodenoscopy (egd) procedure performed on (b)(6) 2022.The patient's anatomy was not tortuous and was not dilated prior to stent placement.The patient was regularly monitored with imaging after stent placement.On (b)(6) 2022, during a routine follow-up, imaging showed the agile esophageal otw fully covered stent (the subject of this report) had migrated.Egd with stent replacement procedure was performed and the agile esophageal otw fully covered stent was removed from the patient with forceps.A second agile esophageal otw fully covered stent (the subject of mfr.Report # 3005099803-2022-07928) was deployed; however, during removal of the delivery system, the second agile esophageal stent got caught on the delivery catheter and the stent was removed together with the delivery system.The procedure was completed with another agile esophageal stent.There were no patient complications reported as a result of this event.Note: it was reported that the agile esophageal otw fully covered stent was implanted in the lower esophagus to treat a perforation.Per the agile esophageal fully covered otw stent system instructions for use (ifu), "the stent is intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent esophageal fistulas." the agile esophageal otw stent is not indicated for perforation.
Event or Problem Description
Note: this report pertains to one of the two devices used on the same patient.Refer to manufacturer report# 3005099803-2022-07928 and 005099803-2022-07929 for the associated device information.It was reported to boston scientific corporation on december 29, 2022, that an agile esophageal otw fully covered stent was implanted in the lower esophagus to treat a perforation during an esophagogastroduodenoscopy (egd) procedure performed on (b)(6) 2022.The patient's anatomy was not tortuous and was not dilated prior to stent placement.The patient was regularly monitored with imaging after stent placement.On december 17, 2022, during a routine follow-up, imaging showed the agile esophageal otw fully covered stent (the subject of this report) had migrated.Egd with stent replacement procedure was performed and the agile esophageal otw fully covered stent was removed from the patient with forceps.A second agile esophageal otw fully covered stent (the subject of mfr.Report # 3005099803-2022-07928) was deployed; however, during removal of the delivery system, the second agile esophageal stent got caught on the delivery catheter and the stent was removed together with the delivery system.The procedure was completed with another agile esophageal stent.There were no patient complications reported as a result of this event.Note: it was reported that the agile esophageal otw fully covered stent was implanted in the lower esophagus to treat a perforation.Per the agile esophageal fully covered otw stent system instructions for use (ifu), "the stent is intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent esophageal fistulas." the agile esophageal otw stent is not indicated for perforation.It was reported that after a complete deployment of the second agile esophageal stent (the subject of mfr.Report # 3005099803-2022-07928), a bsc clip broke.The physician grabbed the stent retrieval suture when trying to grab the clip.The stent was then pulled out from the patient while retrieving the broken clip.In the physician's assessment, there was no alleged malfunction against the second agile esophageal stent.Note: it was reported that the guidewire used during the procedure was a.025 short wire.Per the agile esophageal fully covered otw ifu, the required guidewire to use is a 0.038 in (0.97 mm), stiff-bodied 260 cm guidewire with floppy tip.The user did not follow the required guidewire for the procedure.
Additional Manufacturer Narrative
Block b5 has been updated with additional information received on january 13, 2023.Block h6: imdrf device code a010402 captures the reportable event of stent migration.

• 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: 16136819
• Report Number: 3005099803-2022-07929
• Device Sequence Number: 6704623
• Product Code: ESW
• UDI-Device Identifier: 00191506006648
• UDI-Public: 00191506006648
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/30/2023

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: 04/04/2024
• Device Model Number: M00517770
• Device Catalogue Number: 1777
• Device Lot Number: 0029169175
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/29/2022
• Supplement Date Received by Manufacturer: 01/13/2023
• Initial Report FDA Received Date: 01/11/2023
• Supplement Report FDA Received Date: 01/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/05/2022
• 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: 62 YR
• Patient Sex: Unknown
• Patient Weight: 84 KG