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

Model Number	M00514240
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/31/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to boston scientific corporation on (b)(6) 2023 that an ultraflex esophageal proximal covered stent was to be implanted in the distal esophagus to treat a 5cm malignant stenosis during a gastroscopy with stent placement procedure performed on (b)(6) 2023.The patients anatomy was not tortuous and was not dilated prior to stent placement.During the procedure, the ultraflex esophageal stent was deployed in the patient; however, the proximal end of the stent was unable to expand.An attempt to dilate the stent with endoscope was performed but the stent was still unable to expand.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.
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
Block h6: imdrf device code a150101 captures the reportable event of ultraflex esophageal stent failure to expand.Block h10: a fully expanded ultraflex esophageal proximal covered stent was received for analysis; the delivery system was not returned.Visual and microscopic inspections found the wires unraveled in the flare section.No other issues were noted to the stent.The reported event of stent failure to expand was confirmed as photo of the device provided showed the stent was unable to fully expand inside the patient's anatomy.It is most likely that procedural factors such as lesion characteristics, handling of the device, and the technique used by the physician during deployment of the stent resulted to the reported event of stent failure to expand.Additionally, the wires of the stent were found unraveled in the flare section, it is possible that the manner the device was manipulated during removal with forceps could have caused the observed event.Therefore, a review and analysis of all available information indicated 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.
Event or Problem Description
It was reported to boston scientific corporation on january 31, 2023 that an ultraflex esophageal proximal covered stent was to be implanted in the distal esophagus to treat a 5cm malignant stenosis during a gastroscopy with stent placement procedure performed on (b)(6) 2023.The patient's anatomy was not tortuous and was not dilated prior to stent placement.During the procedure, the ultraflex esophageal stent was deployed in the patient; however, the proximal end of the stent was unable to expand.An attempt to dilate the stent with endoscope was performed but the stent was still unable to expand.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.

• 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: 16379409
• Report Number: 3005099803-2023-00754
• Device Sequence Number: 5708838
• Product Code: ESW
• UDI-Device Identifier: 08714729716105
• UDI-Public: 08714729716105
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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): 03/24/2023

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: 02/16/2024
• Device Model Number: M00514240
• Device Catalogue Number: 1424
• Device Lot Number: 0028878942
• 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: 01/31/2023
• Supplement Date Received by Manufacturer: 03/09/2023
• Initial Report FDA Received Date: 02/15/2023
• Supplement Report FDA Received Date: 03/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/16/2022
• 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: Unknown