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

Model Number	M00513840
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Unspecified Tissue Injury (4559)
Date of Event	11/09/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a04 captures the reportable event of tip damaged/defective.
Event or Problem Description
It was reported to boston scientific corporation that an ultraflex esophageal proximal covered stent was used to treat a 5.6cm esophageal cancer during a stent placement procedure performed on (b)(6) 2024.The patient's anatomy was tortuous and was dilated prior to stent placement.During the procedure, the stent was advanced through the throat along with the guidewire; however, the stent deployment suture was rubbed on the lesion site, causing a bleed.The stent was then withdrawn, re-smeared with couplant, and placed again at the lesion site, but the same problem occurred.Upon removing the device, it was noted that the tip of the stent was kinked.The procedure was completed with another ultraflex esophageal stent.The patient's condition following the procedure was reported to be stable.
Additional Manufacturer Narrative
Block h6: imdrf device code a04 captures the reportable event of tip damaged/defective.Block h11: an ultraflex esophageal proximal covered delivery system was received for analysis; the stent was not returned.Visual inspection found that the tip was kinked.No other problems were noted with the delivery system.Product analysis confirmed the reported event of tip damaged/defective.The reported event was most likely due to procedural factors such as lesion characteristics, handling of the device, and the technique used by the physician (force applied).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 proximal covered stent was used to treat a 5.6cm esophageal cancer during a stent placement procedure performed on (b)(6) 2024.The patient's anatomy was tortuous and was dilated prior to stent placement.During the procedure, the stent was advanced through the throat along with the guidewire; however, the stent deployment suture was rubbed on the lesion site, causing a bleed.The stent was then withdrawn, re-smeared with couplant, and placed again at the lesion site, but the same problem occurred.Upon removing the device, it was noted that the tip of the stent was kinked.The procedure was completed with another ultraflex esophageal stent.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: 20896729
• Report Number: 3005099803-2024-06199
• Device Sequence Number: 9053701
• Product Code: ESW
• UDI-Device Identifier: 08714729716099
• UDI-Public: 08714729716099
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K130004
• 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): 01/16/2025

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: 11/13/2024
• Device Model Number: M00513840
• Device Catalogue Number: M00513840
• Device Lot Number: 0030530444
• 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: 11/13/2024
• Supplement Date Received by Manufacturer: 12/26/2024
• Initial Report FDA Received Date: 12/10/2024
• Supplement Report FDA Received Date: 01/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/14/2022
• 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: 78 YR
• Patient Sex: Female
• Patient Weight: 61 KG