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

Model Number	M00517240
Medical Device Problem Code	Wrong Label (4073)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/01/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to boston scientific corporation on february 02, 2023 that an agile esophageal partially covered stent was to be implanted to treat a 7cm malignant stricture in the lower esophagus during an esophagogastroduodenoscopy (egd) with stent placement procedure performed on (b)(6) 2023.The patient's anatomy was not tortuous and was not dilated prior to stent placement.During the procedure, the agile esophageal stent was successfully placed inside the patient; however, it was noticed that the stent was unable to provide the needed coverage.Subsequently, the agile esophageal stent was removed with forceps and the procedure was rescheduled.Upon checking, it was noticed that the 10mm x 6cm agile esophageal stent was incorrectly labeled as 18mm x 12.5cm agile esophageal stent.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Patient's exact age is unknown; however, it was reported that the patient was over the age of 18.Imdrf device code a210106 captures the reportable event of label incorrect one used.
Additional Manufacturer Narrative
Block a2: patient's exact age is unknown; however, it was reported that the patient was over the age of 18.Block h6: imdrf device code a210106 captures the reportable event of label incorrect one used.Block h10: an agile esophageal partially covered stent was received for analysis; the delivery system was not returned.The stent was visually inspected and no problems were noted.The outer diameter (od) of the stent was measured and found to be within specification.Product analysis did not confirm the reported event of label incorrect one used as the stent's measurement corresponds to the reported upn.There is no indication of what the customer reported because the stent was within specification during dimensional inspection.Therefore, a review and analysis of all available information indicated the most probable cause is no problem detected.A product labeling review identified that the device was used per the instructions for use (ifu) / product label.
Event or Problem Description
It was reported to boston scientific corporation on february 02, 2023 that an agile esophageal partially covered stent was to be implanted to treat a 7cm malignant stricture in the lower esophagus during an esophagogastroduodenoscopy (egd) with stent placement procedure performed on (b)(6) 2023.The patient's anatomy was not tortuous and was not dilated prior to stent placement.During the procedure, the agile esophageal stent was successfully placed inside the patient; however, it was noticed that the stent was unable to provide the needed coverage.Subsequently, the agile esophageal stent was removed with forceps and the procedure was rescheduled.Upon checking, a 10mm x 6cm agile esophageal stent was incorrectly labeled as 18mm x 12.5cm agile esophageal stent.There were no patient complications reported as a result of this event.

• Brand Name: AGILE ESOPHAGEAL
• 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: 16436213
• Report Number: 3005099803-2023-00858
• Device Sequence Number: 3151088
• Product Code: ESW
• UDI-Device Identifier: 08714729972945
• UDI-Public: 08714729972945
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K180144
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 03/24/2023

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: 09/29/2024
• Device Model Number: M00517240
• Device Catalogue Number: 1724
• Device Lot Number: 0030251667
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/02/2023
• Supplement Date Received by Manufacturer: 03/09/2023
• Initial Report FDA Received Date: 02/24/2023
• Supplement Report FDA Received Date: 03/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/30/2022
• 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: Male