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

Model Number	M00513750
Medical Device Problem Codes	Activation, Positioning or Separation Problem (2906); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/26/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block e1: initial reporter address 1: (b)(6).Block h6: imdrf device code a15 captures the reportable event of ultraflex esophageal stent partially deployed.
Event or Problem Description
It was reported to boston scientific corporation that an ultraflex esophageal stent was to be implanted in the esophagus to treat an esophageal stricture during an esophageal stenting procedure performed on (b)(6) 2024.During the procedure, the stent was not opening and procedure got cancelled.A photo of the complaint device was provided by the complaint and showed the stent was partially deployed on the delivery system.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Blocks b5 and h6 (impact code) have been updated with additional information received on july 28, 2024.Block e1: initial reporter address 1: (b)(6).Block h6: imdrf device code a15 captures the reportable event of ultraflex esophageal stent partially deployed.
Event or Problem Description
It was reported to boston scientific corporation that an ultraflex esophageal stent was to be implanted in the esophagus to treat an esophageal stricture during an esophageal stenting procedure performed on (b)(6) 2024.During the procedure, the stent was not opening and procedure got cancelled.A photo of the complaint device was provided by the complaint and showed the stent was partially deployed on the delivery system.There were no patient complications reported as a result of this event.Additional information received on july 28, 2024: it was reported that the ultraflex esophageal stent was to be implanted in the lower esophageal sphincter.The procedure was completed with a wallflex esophageal stent.
Event or Problem Description
It was reported to boston scientific corporation that an ultraflex esophageal stent was to be implanted in the esophagus to treat an esophageal stricture during an esophageal stenting procedure performed on (b)(6) 2024.During the procedure, the stent was not opening and procedure got cancelled.A photo of the complaint device was provided by the complaint and showed the stent was partially deployed on the delivery system.There were no patient complications reported as a result of this event.Additional information received on july 28, 2024.It was reported that the ultraflex esophageal stent was to be implanted in the lower esophageal sphincter.The procedure was completed with a wallflex esophageal stent.
Additional Manufacturer Narrative
Block e1: initial reporter address 1: (b)(6).Block h6: imdrf device code a15 captures the reportable event of ultraflex esophageal stent partially deployed.Block h11: an ultraflex esophageal stent was received for analysis.The stent was returned partially deployed.Visual inspection revealed that the delivery shaft was kinked.A functional examination was performed by pulling the finger ring, and the stent was successfully deployed without any problems; no resistance was felt.Media inspection, based on the photos provided by the customer, showed that the device was inside the package with no damage noted.The observed damage was most likely due to procedural factors, such as lesion characteristics, handling of the device, the technique used by the physician, and the amount of force applied to the device, which contributed to the kink observed on the delivery system.Product analysis confirmed the reported event of the stent being partially deployed.A labeling review was performed, and based on the information available, the device was used in accordance with the instructions for use (ifu) and product label.Additionally, "stent partially deployed" is documented within the ifu as a potential adverse event associated with the use of the device.Therefore, a review and analysis of all available information indicated that the most probable cause is a known inherent risk of the device.

• 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: 19817175
• Report Number: 3005099803-2024-03523
• Device Sequence Number: 8671127
• 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,Followup
• Report Date (Section B): 01/08/2025

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: 07/12/2024
• Device Model Number: M00513750
• Device Catalogue Number: M00513750
• Device Lot Number: 0029753069
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/26/2024
• Supplement Date Received by Manufacturer: 07/28/2024; 12/09/2024
• Initial Report FDA Received Date: 07/24/2024
• Supplement Report FDA Received Date: 08/22/2024; 01/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/13/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Sex: Unknown