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

Model Number	M00513850
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Positioning Problem (3009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/21/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A2: the patient's exact age is unknown; however, it was reported that the patient was over the age of 18.H6: imdrf device code a1502 captures the reportable event of a stent positioning issue.
Event or Problem Description
It was reported to boston scientific corporation that an ultraflex esophageal ng proximal covered stent was to be implanted in the middle third of the esophagus to treat malignant stricture secondary to esophageal cancer during an esophageal stent implantation procedure performed on (b)(3) 2023.The patient's anatomy was tight and was not dilated prior to stent placement.During the procedure, the stent was difficult to position, and it was deployed near the pharynx.The stent was removed with forceps and another ultraflex esophageal stent was used to complete the procedure.There were no patient complications reported as a result of this event.The patient's condition following the procedure was reported to be stable.
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 a1502 captures the reportable event of a stent positioning issue.Block h10: the ultraflex esophageal ng proximal covered stent and delivery system were received for analysis.Visual investigation found that the stent was fully expanded and deployed from the delivery system, and the shaft was kinked.No other damages were noted with the stent or the delivery system.Product analysis did not confirm the reported event of the stent positioning issue because this event occurred during the procedure and was not possible to replicate in the laboratory of analysis, and there was no objective evidence or descriptive conditions to confirm the reported event.Additionally, the investigation concluded that the additional finding of shaft kinking was most likely due to procedural factors such as lesion characteristics, the handling of the device, and the technique used by the physician (force applied), which could have resulted in the damage encountered in the device.Therefore, a review and analysis of all available information indicated that the most probable cause is no problem detected.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 that an ultraflex esophageal ng proximal covered stent was to be implanted in the middle third of the esophagus to treat malignant stricture secondary to esophageal cancer during an esophageal stent implantation procedure performed on (b)(6) 2023.The patient's anatomy was tight and was not dilated prior to stent placement.During the procedure, the stent was difficult to position, and it was deployed near the pharynx.The stent was removed with forceps and another ultraflex esophageal stent was used to complete the procedure.There were no patient complications reported as a result of this event.The patient's condition following the procedure was reported to be stable.

• 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: 18367045
• Report Number: 3005099803-2023-06749
• Device Sequence Number: 7730841
• Product Code: ESW
• UDI-Device Identifier: 08714729716075
• UDI-Public: 08714729716075
• Combination Product (Y/N): N
• Initial Reporter Country: UY
• 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): 02/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/19/2024
• Device Model Number: M00513850
• Device Catalogue Number: 1385
• Device Lot Number: 0030180657
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/28/2023
• Supplement Date Received by Manufacturer: 01/10/2024
• Initial Report FDA Received Date: 12/20/2023
• Supplement Report FDA Received Date: 02/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/20/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male