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

Model Number	M00513740
Medical Device Problem Codes	Failure to Advance (2524); Activation, Positioning or Separation Problem (2906); Material Deformation (2976); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a15 captures the reportable event of stent partially deployed.
Event or Problem Description
It was reported to boston scientific corporation that an ultraflex esophageal ng distal covered stent was to be implanted in the esophagus to treat a malignant 5 cm esophageal obstruction during an esophageal stenting 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 advancing the delivery system across the lesion, and the shaft was kinked.The whole delivery system was removed and re-inserted, but the same problem occurred.The stent was attempted to be deployed, but the shaft ultimately bowed, and the distal part of the stent automatically deployed partially.The stent was removed from the patient, and another ultraflex esophageal stent was used to complete the procedure.There were no patient complications reported as a result of this event.
Event or Problem Description
It was reported to boston scientific corporation that an ultraflex esophageal ng distal covered stent was to be implanted in the esophagus to treat a malignant 5 cm esophageal obstruction during an esophageal stenting 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 advancing the delivery system across the lesion, and the shaft was kinked.The whole delivery system was removed and re-inserted, but the same problem occurred.The stent was attempted to be deployed, but the shaft ultimately bowed, and the distal part of the stent automatically deployed partially.The stent was removed from the patient, and another ultraflex esophageal stent was used to complete the procedure.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: imdrf device code a15 captures the reportable event of stent partially deployed.Block h10: the ultraflex esophageal ng distal covered stent and delivery system were received for analysis.Visual and media analyses found that the stent was partially deployed on the delivery system.Functional analysis related to the deployment of the stent was performed by pulling the finger ring, but the shaft bowed because of the kink noted on the shaft.Therefore, the black deployment suture, which was distal to the delivery handle, was directly pulled, and the stent was released.No other damages were noted with the stent or the delivery system.Product analysis confirmed the reported events of stent partial deployment and shaft kinking and bending; however, the reported event of stent difficulty crossing the lesion occurred during the procedure and was not possible to replicate in the laboratory of analysis.Also, the device met all the manufacturing requirements, and it passed dimensional inspections during the product analysis.The investigation concluded that the reported events of stent partial deployment and shaft kinking and bending were most likely due to procedural factors such as lesion characteristics, the handling of the device, and the technique used by the physician trying to cross the lesion, which could have resulted in the damages noted in the device, and these damages could have prevented the stent from completely deploying during the procedure.Therefore, a review and analysis of all available information indicated that 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.

• 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: 17789291
• Report Number: 3005099803-2023-05056
• Device Sequence Number: 7750262
• Product Code: ESW
• UDI-Device Identifier: 08714729716167
• UDI-Public: 08714729716167
• 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): 04/10/2024

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: 02/09/2024
• Device Model Number: M00513740
• Device Catalogue Number: 1374
• Device Lot Number: 0028834337
• 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: 09/01/2023
• Supplement Date Received by Manufacturer: 03/19/2024
• Initial Report FDA Received Date: 09/21/2023
• Supplement Report FDA Received Date: 04/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/09/2022
• 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: 67 YR
• Patient Sex: Female
• Patient Weight: 64 KG
• Patient Race: Asian