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

Model Number	M00513750
Medical Device Problem Codes	Activation, Positioning or Separation Problem (2906); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/29/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation on (b)(6) 2022, that an ultraflex esophageal ng distal release covered stent was to be implanted in the esophagus to treat esophageal cancer during an esophageal self-expanding metal stent placement procedure performed on (b)(6) 2022.The patient's anatomy was not tortuous and was dilated prior to stent placement.During the procedure, the ultraflex esophageal stent did not fully deploy.The ultraflex esophageal stent was removed from the patient partially deployed on the delivery system and the procedure was completed with another ultraflex esophageal stent.There were no patient complications reported as a result of this event.The patient condition following the procedure was reported to be stable.
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
Imdrf device code a15 captures the reportable event of stent partially deployed.The ultraflex esophageal ng distal release covered stent and delivery system were returned for analysis.Visual inspection found that the stent was partially deployed on the delivery system.Visual and microscopic inspection of the deployment suture found a white strand in one of the suture knots, preventing the release of the stent deployment suture.No other damages were noted with the stent or the delivery system.Product analysis confirmed the reported event of partial stent deployment.An investigation has been initiated to address the strand found in the knot of the deployment suture and the investigation is currently ongoing.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 october 29, 2022, that an ultraflex esophageal ng distal release covered stent was to be implanted in the esophagus to treat esophageal cancer during an esophageal self-expanding metal stent placement procedure performed on (b)(6) 2022.The patient's anatomy was not tortuous and was dilated prior to stent placement.During the procedure, the ultraflex esophageal stent did not fully deploy.The ultraflex esophageal stent was removed from the patient partially deployed on the delivery system and the procedure was completed with another ultraflex esophageal stent.There were no patient complications reported as a result of this event.The patient 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: 15828264
• Report Number: 3005099803-2022-06778
• Device Sequence Number: 12301347
• Product Code: ESW
• UDI-Device Identifier: 08714729649113
• UDI-Public: 08714729649113
• 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
• Report Date (Section B): 11/06/2023

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: 03/13/2024
• Device Model Number: M00513750
• Device Catalogue Number: 1375
• Device Lot Number: 0029037260
• 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: 10/29/2022
• Supplement Date Received by Manufacturer: 10/10/2023
• Initial Report FDA Received Date: 11/18/2022
• Supplement Report FDA Received Date: 11/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/14/2022
• 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 Sex: Unknown