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

Model Number M00513740

Device Problems Failure to Advance (2524); Activation, Positioning or Separation Problem (2906); Material Deformation (2976); Material Twisted/Bent (2981)

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

Event Date 12/13/2022

Event Type  malfunction  

Manufacturer Narrative

Initial reporter's address1: (b)(6).

Event Description

It was reported to boston scientific corporation on (b)(6) 2022, that an ultraflex esophageal ng distal release stent was to be implanted to treat an 8 cm malignant esophageal stricture during an esophageal stent placement procedure performed on (b)(6) 2022.The patient anatomy was tortuous and was dilated prior to stent placement.During the procedure, the stent delivery system had difficulty crossing the stricture, and the delivery shaft got bent.The black stent deployment suture became stuck, and the stent could not be deployed.The ultrafex esophageal stent was removed from the patient partially deployed on the delivery system.The procedure was complete with a different device.There were no patient complications reported as a result of this event.The patient condition at the conclusion of the procedure was reported to be fine.

Manufacturer Narrative

E1: (b)(6).H6: imdrf device code a15 captures the reportable event of ultraflex esophageal stent partially deployed.H10: an ultraflex esophageal distal covered stent and delivery system were received for analysis.The stent was received partially deployed.Visual inspection found the shaft slightly bent.The deployment suture was inspected and no problems or knots were noted.The outer diameter of the stent was measured and found to be within specification.Functional inspection revealed that it was possible to deploy the stent by holding the handle hub in the palm of one hand, grasping and retracting the finger ring with the other hand.No other problems were noted to the stent and delivery system.Product analysis confirmed the reported events of stent partially deployed and shaft bent; however, the reported event of stent deployment suture knotted was not confirmed as no problems were noted during visual inspection.The reported event of delivery system difficult to cross lesion could not be confirmed as this occurred during the procedure and is not possible to replicate in the laboratory of analysis.It may be that the patient's tortuous anatomy contributed to the difficulty in crossing the stricture and the shaft being bent which then resulted to the stent being partially deployed.Therefore, a review and analysis of all available information indicated the most probable cause is adverse event related to patient condition.A product labeling review identified that the device was used per the instructions for use (ifu) / product label.

Event Description

It was reported to boston scientific corporation on december 13, 2022, that an ultraflex esophageal ng distal release stent was to be implanted to treat an 8 cm malignant esophageal stricture during an esophageal stent placement procedure performed on (b)(6) 2022.The patient anatomy was tortuous and was dilated prior to stent placement.During the procedure, the stent delivery system had difficulty crossing the stricture, and the delivery shaft got bent.The black stent deployment suture became stuck, and the stent could not be deployed.The ultrafex esophageal stent was removed from the patient partially deployed on the delivery system.The procedure was complete with a different device.There were no patient complications reported as a result of this event.The patient condition at the conclusion of the procedure was reported to be fine.

• 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: 16090642
• MDR Text Key: 306845758
• Report Number: 3005099803-2022-07866
• Device Sequence Number: 1
• Product Code: ESW
• UDI-Device Identifier: 08714729716167
• UDI-Public: 08714729716167
• Combination Product (y/n): N
• Reporter Country Code: IN
• 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,Followup
• Report Date: 06/06/2023

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
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2023
• Device Model Number: M00513740
• Device Catalogue Number: 1374
• Device Lot Number: 0028468771
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/13/2022
• Initial Date FDA Received: 01/03/2023
• Supplement Dates Manufacturer Received: 05/18/2023
• Supplement Dates FDA Received: 06/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/30/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 76 YR
• Patient Sex: Male