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

Model Number M00513840

Device Problem Failure to Advance (2524)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/27/2021

Event Type  malfunction  

Event Description

It was reported to boston scientific corporation that an ultraflex esophageal ng proximal release covered stent was to be implanted to treat an esophageal cancer during a stent placement procedure performed on (b)(6) 2021.The patient's anatomy was dilated prior to stent placement.During the procedure, the stent delivery system could not cross the lesion.The stent was removed and a wallflex esophageal stent was implanted to complete the procedure.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.Note: this event has been deemed an mdr reportable event based on investigation result which revealed the stent was partially deployed.

Manufacturer Narrative

Patient's exact age is unknown; however, it was reported that the patient was over the age of 18.(b)(4).An ultraflex esophageal ng proximal release covered stent and delivery system were received for analysis.Visual examination of the returned device found the stent was partially deployed.The shaft was returned bent.Functional evaluation was performed and the stent was able to be deployed by holding the delivery catheter stationary with one hand and grasping the finger ring attached to the handle with the other hand and gently pulled the finger ring to release the stent.No other problems were noted to the stent and delivery system.The reported event of delivery system difficult to cross lesion occurred during the procedure and could not be functionally/visually verified.The damages observed of the returned device were most likely due to procedural or anatomical factors encountered during the procedure.Handling and manipulation of the device during the procedure could lead to the bent shaft, difficultly of the device crossing the lesion and the partially deployed stent.Therefore, a review and analysis of all available information indicated the most probable cause is adverse event related to procedure.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.

• Brand Name: ULTRAFLEX ESOPHAGEAL NG
• Type of Device: 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: 13020825
• MDR Text Key: 284126971
• Report Number: 3005099803-2021-07753
• Device Sequence Number: 1
• Product Code: ESW
• UDI-Device Identifier: 08714729716099
• UDI-Public: 08714729716099
• Combination Product (y/n): N
• Reporter Country Code: UY
• PMA/PMN Number: K091816
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/16/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 03/12/2022
• Device Model Number: M00513840
• Device Catalogue Number: 1384
• Device Lot Number: 0025347881
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/22/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/24/2021
• Initial Date FDA Received: 12/16/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/12/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Sex: Male