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

Model Number	M00513740
Medical Device Problem Code	Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2024
Type of Reportable Event	Malfunction
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 8 cm esophageal stricture during a metal stenting procedure performed on (b)(6) 2024.The patient's anatomy was not tortuous and was dilated prior to stent placement.During the procedure, the stent could not be deployed, even after multiple attempts at pulling the deployment suture.The stent was removed from the patient partially deployed on the delivery system, and the procedure was completed with a different model of esophageal stent.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block a2: the patient's exact age is unknown; however, it was reported that the patient was over the age of 18.Block h6: imdrf device code a15 captures the reportable event of a stent's partial deployment.
Additional Manufacturer Narrative
Block a2: the patient's exact age is unknown; however, it was reported that the patient was over the age of 18.Block h6: imdrf device code a15 captures the reportable event of a stent's partial deployment.Bock h11: an ultraflex esophageal distal release stent was received for analysis.The stent was returned partially deployed.Visual inspection was performed and found the shaft was bent.Functional examination was performed by pulling the finger ring and the stent was deployed without resistance felt.No other damages were noted to the stent and delivery system.Product analysis confirmed the reported event of stent partially deployed.The damages noted were most likely due to procedural factors encountered during the procedure.It may be the characteristics of the lesion, the techniques used by the physician, or the amount of force applied to the device during use resulted to the damages observed.Therefore, a review and analysis of all available information indicated the most probable cause is adverse event related to procedure.
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 8 cm esophageal stricture during a metal stenting procedure performed on (b)(5) 2024.The patient's anatomy was not tortuous and was dilated prior to stent placement.During the procedure, the stent could not be deployed, even after multiple attempts at pulling the deployment suture.The stent was removed from the patient partially deployed on the delivery system, and the procedure was completed with a different model of esophageal stent.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: 18540239
• Report Number: 3005099803-2024-00076
• Device Sequence Number: 9163367
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/28/2024

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: 11/28/2024
• Device Model Number: M00513740
• Device Catalogue Number: 1374
• Device Lot Number: 0030616076
• 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: 01/01/2024
• Supplement Date Received by Manufacturer: 08/01/2024
• Initial Report FDA Received Date: 01/18/2024
• Supplement Report FDA Received Date: 08/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/29/2022
• 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