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

Model Number	M00513750
Medical Device Problem Codes	Positioning Failure (1158); Failure to Advance (2524); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/17/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation on (b)(6) 2023 that an ultraflex esophageal distal covered stent was used in the esophagus to treat an 8cm malignant stricture during a stent placement procedure performed on (b)(6) 2023.The patient's anatomy was tortuous and was dilated prior to stent placement.During the procedure, there was difficulty in crossing the stricture.Subsequently, the shaft broke and the stent was unable to deploy.The stent was fully covered by the deployment suture when it was removed from the patient.The procedure was cancelled due to device availability.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: impact code f1001 is being used to capture the reportable issue of aborted/cancelled procedure.
Additional Manufacturer Narrative
Block h6: impact code f1001 is being used to capture the reportable issue of aborted/cancelled procedure.Block h10: an ultraflex esophageal distal covered stent and delivery system were received for analysis.The stent was received partially deployed.Visual inspection found the shaft kinked and damaged (smashed).During functional inspection, it was not possible to deploy the stent by pulling the finger ring due to the kink noted on the shaft; however, the stent was able to be deployed by pulling the black deployment suture distal to the delivery handle.The outer diameter (od) of the stent was measured and found to be within specification.No other problems were noted with the stent and delivery system.The reported event of delivery system difficult to cross lesion could not be confirmed as this occurred during the procedure and is not possible to replicate in the laboratory of analysis, while the reported event of shaft detachment of device or device component was not confirmed because the shaft was received in whole without detachments.The reported event of stent failure to deploy can be confirmed because the stent was received partially deployed.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 resulted in the observed events of shaft kinked and damaged which then caused the stent to be partially deployed.Therefore, a review and analysis of all available information indicated the most probable cause is adverse event related to procedure.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 may 18, 2023 that an ultraflex esophageal distal covered stent was used in the esophagus to treat an 8cm malignant stricture during a stent placement procedure performed on (b)(6) 2023.The patient's anatomy was tortuous and was dilated prior to stent placement.During the procedure, there was difficulty in crossing the stricture.Subsequently, the shaft broke and the stent was unable to deploy.The stent was fully covered by the deployment suture when it was removed from the patient.The procedure was cancelled due to device availability.There were no patient complications reported as a result of this event.

• 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: 17065239
• Report Number: 3005099803-2023-02971
• Device Sequence Number: 6129407
• Product Code: ESW
• UDI-Device Identifier: 08714729649113
• UDI-Public: 08714729649113
• 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): 09/26/2023

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: 12/13/2024
• Device Model Number: M00513750
• Device Catalogue Number: 1375
• Device Lot Number: 0030708253
• 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: 05/18/2023
• Supplement Date Received by Manufacturer: 09/07/2023
• Initial Report FDA Received Date: 06/05/2023
• Supplement Report FDA Received Date: 09/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/14/2022
• 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
• Patient Age: 75 YR
• Patient Sex: Female