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

Model Number	M00514210
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/28/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported to boston scientific corporation on (b)(6) 2022, that an ultraflex esophageal ng distal release covered stent was to be implanted to treat a 33cm-44cm malignant esophageal stricture during an esophagogastroduodenoscopy (egd) procedure performed on (b)(6) 2021.The patient's anatomy was tortuous and was not dilated prior to stent placement.During the procedure, the ultraflex esophageal stent did not fully expand.The ultraflex esophageal stent was successfully removed from the patient with forceps.There were no patient complications reported as a result of this event.The patient's condition after the procedure was reported be unchanged.
Additional Manufacturer Narrative
Block b5 has been updated with the additional information received on january 13, 2023.Block h6: imdrf device code a150101 captures the reportable event of stent failure to expand.
Event or Problem Description
It was reported to boston scientific corporation on december 19, 2022, that an ultraflex esophageal ng distal release covered stent was to be implanted to treat a 33cm-44cm malignant esophageal stricture during an esophagogastroduodenoscopy (egd) procedure performed on (b)(6) 2021.The patient's anatomy was tortuous and was not dilated prior to stent placement.During the procedure, the ultraflex esophageal stent did not fully expand.The ultraflex esophageal stent was successfully removed from the patient with forceps.There were no patient complications reported as a result of this event.The patient's condition after the procedure was reported be unchanged.It was reported that another ultraflex esophageal stent was implanted to complete the procedure.

• 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: 16139408
• Report Number: 3005099803-2022-08025
• Device Sequence Number: 6516569
• Product Code: ESW
• UDI-Device Identifier: 08714729121206
• UDI-Public: 08714729121206
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K091816
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/06/2023

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: 04/12/2023
• Device Model Number: M00514210
• Device Catalogue Number: 1421
• Device Lot Number: 0027121311
• 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: 12/19/2022
• Supplement Date Received by Manufacturer: 01/13/2023
• Initial Report FDA Received Date: 01/11/2023
• Supplement Report FDA Received Date: 02/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/12/2021
• 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