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

Model Number	M00513750
Medical Device Problem Code	Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/20/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported to boston scientific corporation on november 04, 2022, that an ultraflex esophageal ng distal release covered stent was to be implanted in the esophagus to treat esophageal cancer during a stent implantation procedure performed on (b)(6) 2022.The patient's anatomy was tight and was not dilated prior to stent placement.During the procedure, the black stent deployment suture got stuck and the ultraflex esophageal stent was unable to be fully deployed.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.
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 a stent implantation procedure performed on(b)(6) 2022.The patient's anatomy was tight and was not dilated prior to stent placement.During the procedure, the black stent deployment suture got stuck and the ultraflex esophageal stent was unable to be fully deployed.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
Block h6: imdrf device code a15 captures the reportable event of stent partially deployed.Block h10: the ultraflex esophageal ng covered stent and delivery system were received for analysis.Visual inspection of the returned device found the stent was partially deployed and the shaft was slightly bent.The deployment suture was also inspected, and no damages or knots were noted.Functional inspection was performed by holding the hub handle in the palm of one hand, grasping and retracting the finger ring with the other hand.By retracting the finger ring, the crocheted suture that binds to the delivery shaft gradually released the stent from the delivery system.No other issues were noted to the stent and delivery system.Product analysis confirmed the reported event of stent partially deployed.The damage noted to the delivery system was most likely due to procedural factors encountered during procedure.It may be that the lesion characteristics, the technique used by the user, and normal procedural difficulties encountered during the procedure, limited the performance of the device and contributed to the kinking of the delivery shaft and could have caused the stent to partially deploy.Therefore, a review and analysis of all available information indicated the most probable cause adverse event related to procedure a product labeling review identified that the device was used per the directions for use (dfu)/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: 15837942
• Report Number: 3005099803-2022-06901
• Device Sequence Number: 14752589
• Product Code: ESW
• UDI-Device Identifier: 08714729649113
• UDI-Public: 08714729649113
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 01/24/2023

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: 11/16/2022
• Device Model Number: M00513750
• Device Catalogue Number: 1375
• Device Lot Number: 0026367068
• 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: 11/04/2022
• Supplement Date Received by Manufacturer: 01/09/2023
• Initial Report FDA Received Date: 11/21/2022
• Supplement Report FDA Received Date: 01/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/16/2020
• 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: 40 YR
• Patient Sex: Male
• Patient Weight: 56 KG