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

Model Number	M00513850
Medical Device Problem Codes	Break (1069); Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/17/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Imdrf device code a15 captures the reportable event of an ultraflex esophageal proximal covered stent partially deployed.
Event or Problem Description
It was reported to boston scientific corporation on 2023 that an ultraflex esophageal proximal covered stent was used to treat a 7cm malignant middle esophageal carcinoma during a stent placement procedure performed on (b)(6) 2023.The patient's anatomy was not tortuous and was dilated prior to stent placement procedure.During the procedure, the black deployment suture stopped unravelling and the stent was unable to fully deploy.The stent was partially deployed when it was removed from the patient.The procedure was cancelled and was rescheduled after a week.There were no patient complications reported as a result of this event.
Event or Problem Description
It was reported to boston scientific corporation on march 18, 2023 that an ultraflex esophageal proximal covered stent was used to treat a 7cm malignant middle esophageal carcinoma during a stent placement procedure performed on march 17, 2023.The patient's anatomy was not tortuous and was dilated prior to stent placement procedure.During the procedure, the black deployment suture stopped unravelling and the stent was unable to fully deploy.The stent was partially deployed when it was removed from the patient.The procedure was cancelled and was rescheduled after a week.There were no patient complications reported as a result of this event.**additional information received on october 10, 2023 and october 15, 2023** the stent was partially released and the black deployment suture was broken.
Additional Manufacturer Narrative
Blocks b5 and h6 (device codes) have been updated with additional information received on october 10, 2023 and october 15, 2023.Block h6: imdrf device code a15 captures the reportable event of an ultraflex esophageal proximal covered stent partially deployed.Imdrf device code a0401 captures the reportable event of an ultraflex esophageal proximal covered stent deployment suture break.Block h10: an ultraflex esophageal proximal covered stent and delivery system were received for analysis.The stent was received fully deployed and expanded.Visual inspection found the shaft bent in different sections.The deployment suture was also returned unraveled with the device.No other problems with the stent and delivery system were noted.The reported event of stent partially deployed was not confirmed because the stent was received fully deployed and expanded.Additionally, the reported event of stent deployment suture break was not confirmed as the deployment suture was received unraveled with no problems.It is most likely that procedural factors such as lesion characteristics, handling of the device, and the technique used by the physician (force applied) could have contributed to the observed event of shaft bent.However, there is no indication of what the customer reported because the stent was received fully deployed and no problems were noted in the deployment suture.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.

• 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: 16657213
• Report Number: 3005099803-2023-01703
• Device Sequence Number: 1700552
• Product Code: ESW
• UDI-Device Identifier: 08714729716075
• UDI-Public: 08714729716075
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/28/2023
• Device Model Number: M00513850
• Device Catalogue Number: 1385
• Device Lot Number: 0028283233
• 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: 03/18/2023
• Supplement Date Received by Manufacturer: 10/03/2023
• Initial Report FDA Received Date: 03/31/2023
• Supplement Report FDA Received Date: 10/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/28/2021
• 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
• Patient Age: 57 YR
• Patient Sex: Male
• Patient Race: Asian