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

Model Number	M00513750
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Codes	Dysphagia/ Odynophagia (1815); Obstruction/Occlusion (2422)
Date of Event	03/23/2023
Type of Reportable Event	Serious Injury
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 patient code e2328 captures the reportable patient complication of esophageal obstruction.Imdrf patient code e1009 captures the reportable patient complication of "inability to feed" dysphagia.Imdrf device code a150101 captures the reportable event of stent failure to expand.Impact code f2202 captures the additional endoscopic procedure.Impact code f2301 is being used to capture the use of another device to remove the stent from the patient and the use of a second ultraflex esophageal stent.
Event or Problem Description
It was reported to boston scientific corporation on (b)(6), 2023, that an ultraflex esophageal ng distal release covered stent was implanted to treat esophageal neoplasm during an esophageal stent placement procedure performed on (b)(6) 2023.On (b)(6) 2023, five days post stent placement, the patient could not eat.An endoscopy was performed, and it was noted that the ultraflex esophageal stent did not expand.The stent was removed from the patient and another ultraflex esophageal stent was implanted in a satisfactory manner and the procedure was completed.The patient condition following the procedure was reported to be stable.The patient is now okay and can feed properly.Note: a photo of the complaint device was provided and showed the stent was fully deployed inside the patient; however, the stent was not fully expanded.
Event or Problem Description
It was reported to boston scientific corporation on (b)(6) 2023, that an ultraflex esophageal ng distal release covered stent was implanted to treat esophageal neoplasm during an esophageal stent placement procedure performed on (b)(6) 2023.On (b)(6) 2023, five days post stent placement, the patient could not eat.An endoscopy was performed, and it was noted that the ultraflex esophageal stent did not expand.The stent was removed from the patient and another ultraflex esophageal stent was implanted in a satisfactory manner and the procedure was completed.The patient condition following the procedure was reported to be stable.The patient is now okay and can feed properly.Note: a photo of the complaint device was provided and showed the stent was fully deployed inside the patient; however, the stent was not fully expanded.Additional information received on april 17, 2023.On (b)(6) 2023, the ultraflex esophageal stent was removed from the patient using forceps.
Additional Manufacturer Narrative
Blocks b5 and d6b (explant date) have been updated with the additional information received on april 17, 2023.Block a2: patient's exact age is unknown; however, it was reported that the patient was over the age of 18.Block h6: imdrf patient code e2328 captures the reportable patient complication of esophageal obstruction.Imdrf patient code e1009 captures the reportable patient complication of "inability to feed" dysphagia.Imdrf device code a150101 captures the reportable event of stent failure to expand.Impact code f2202 captures the additional endoscopic procedure.Impact code f2301 is being used to capture the use of another device to remove the stent from the patient and the use of a second ultraflex esophageal stent.

• Brand Name: ULTRAFLEX ESOPHAGEAL NG
• 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: 16750541
• Report Number: 3005099803-2023-01939
• Device Sequence Number: 8626910
• Product Code: ESW
• UDI-Device Identifier: 08714729649113
• UDI-Public: 08714729649113
• Combination Product (Y/N): N
• Initial Reporter Country: UY
• PMA/510(K) Number: K091816
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/09/2023

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: 08/30/2024
• Device Model Number: M00513750
• Device Catalogue Number: 1375
• Device Lot Number: 0030059637
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/27/2023
• Supplement Date Received by Manufacturer: 04/17/2023
• Initial Report FDA Received Date: 04/17/2023
• Supplement Report FDA Received Date: 05/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/31/2022
• 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