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

Model Number	M00513730
Medical Device Problem Codes	Activation, Positioning or Separation Problem (2906); Material Deformation (2976); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/19/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block e1: the initial reporter address: (b)(6).Block h6: imdrf device code a15 captures the reportable event of stent partial deployment.
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 mid esophagus to treat a malignant 5 cm esophageal stricture during an esophageal self-expanding metal stent (sems) implantation procedure performed on (b)(6) 2023.The patient's anatomy was not tortuous and was dilated prior to stent placement.During the procedure, there was resistance while pulling the deployment suture for several times and it could not be released.The delivery system was removed from the patient, and it was noted the deployment suture was tangled and the stent was partially on the deployed on the delivery system.The procedure was completed with another ultraflex esophageal stent.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 mid esophagus to treat a malignant 5 cm esophageal stricture during an esophageal self-expanding metal stent (sems) implantation procedure performed on (b)(6) 2023.The patient's anatomy was not tortuous and was dilated prior to stent placement.During the procedure, there was resistance while pulling the deployment suture for several times and it could not be released.The delivery system was removed from the patient, and it was noted the deployment suture was tangled and the stent was partially on the deployed on the delivery system.The procedure was completed with another ultraflex esophageal stent.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block e1: the initial reporter address is mission (b)(6).Block h6: imdrf device code a15 captures the reportable event of stent partial deployment.Block h11: an ultraflex esophageal stent was received for analysis.Visual examination found the stent was returned partially deployed.The stent deployment suture was found broken, without knots.No other damages noted to the stent and delivery system.Product analysis confirmed the reported event of stent partially deployed; however, stent deployment suture knotted was not confirmed.The damages noted were most likely due to procedural factors encountered during the procedure.It might be the characteristics of the lesion, handling of the device, the technique used by the physician (force applied), could have resulted in the damages encountered in the device.Therefore, a review and analysis of all available information indicated the most probable cause is adverse event related to 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: 18093526
• Report Number: 3005099803-2023-06074
• Device Sequence Number: 20552201
• Product Code: ESW
• UDI-Device Identifier: 08714729716150
• UDI-Public: 08714729716150
• 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): 09/17/2024

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: 09/18/2024
• Device Model Number: M00513730
• Device Catalogue Number: 1373
• Device Lot Number: 0030170746
• 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: 10/19/2023
• Supplement Date Received by Manufacturer: 08/23/2024
• Initial Report FDA Received Date: 11/08/2023
• Supplement Report FDA Received Date: 09/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/19/2022
• 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 Sex: Male
• Patient Race: Asian