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

Model Number	M00513730
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/10/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to boston scientific corporation on april 11, 2023 that an ultraflex esophageal distal covered stent was implanted to treat a 6cm stricture in the distal end of esophagus during a stent placement procedure performed on (b)(6) 2023.The patient's anatomy was tortuous and was dilated prior to stent placement.During the procedure, the stent was fully deployed; however, it was noticed that the stent was unable to open properly in the stricture and was inverted from behind.The stent was removed with forceps and a different device was used to complete the procedure.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: imdrf device code a150101 captures the reportable event of stent failure to expand.
Event or Problem Description
It was reported to boston scientific corporation on april 11, 2023 that an ultraflex esophageal distal covered stent was implanted to treat a 6cm stricture in the distal end of esophagus during a stent placement procedure performed on (b)(6) 2023.The patient's anatomy was tortuous and was dilated prior to stent placement.During the procedure, the stent was fully deployed; however, it was noticed that the stent was unable to open properly in the stricture and was inverted from behind.The stent was removed with forceps and a different device was used to complete the procedure.There were no patient complications reported as a result of this event.**additional information received on april 28, 2023** the stent was implanted to treat a 6cm malignant stricture.
Additional Manufacturer Narrative
Block b5 has been updated with additional information received on april 28, 2023.Block h6: imdrf device code a150101 captures the reportable event of stent failure to expand.
Event or Problem Description
It was reported to boston scientific corporation on (b)(6) 2023 that an ultraflex esophageal distal covered stent was implanted to treat a 6cm stricture in the distal end of esophagus during a stent placement procedure performed on (b)(6) 2023.The patient's anatomy was tortuous and was dilated prior to stent placement.During the procedure, the stent was fully deployed; however, it was noticed that the stent was unable to open properly in the stricture and was inverted from behind.The stent was removed with forceps and a different device was used to complete the procedure.There were no patient complications reported as a result of this event.Additional information received on april 28, 2023.The stent was implanted to treat a 6cm malignant stricture.
Additional Manufacturer Narrative
Block h6: imdrf device code a150101 captures the reportable event of stent failure to expand.Block h10: an ultraflex esophageal distal covered stent and delivery system were received for analysis.The stent was received fully deployed and expanded.Visual and microscopic inspections found a knot on the retention suture in the flare.The shaft was noted to be in good condition.No other problems were noted with the stent and delivery system.Product analysis did not confirm the reported event of stent failure to expand because the stent was received fully deployed and expanded.It is most likely that the observed event of stent retention suture knotted could have contributed to the stent being unable to expand during the procedure; however, there is not an objective evidence or descriptive conditions to confirm the reported event.No problems were found that could have been related to the reported event during the manufacturing documentation review.Additionally, there are in-process controls such as applying green suture, stent prep, autocrochet, and final inspection work stent that detect problems related to the application and condition of the green retention suture in ultraflex stents.It is not known how the retention suture became looped around the incorrect stent loop.The investigation findings do not lead to a clear conclusion about the cause of the reported event, therefore the most probable cause was unable to be established.A labeling review was performed and, from the information available, this device was used per the instructions for use (ifu) / product label.

• 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: 16845071
• Report Number: 3005099803-2023-02236
• Device Sequence Number: 15168698
• 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,Followup
• Report Date (Section B): 01/05/2024

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: 03/28/2024
• Device Model Number: M00513730
• Device Catalogue Number: 1373
• Device Lot Number: 0029126541
• 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: 04/11/2023
• Supplement Date Received by Manufacturer: 04/11/2023; 12/12/2023
• Initial Report FDA Received Date: 05/01/2023
• Supplement Report FDA Received Date: 05/02/2023; 01/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/29/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown
• Patient Race: Asian