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

Model Number M00513730

Device Problems Activation, Positioning or Separation Problem (2906); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 11/15/2023

Event Type  malfunction  

Manufacturer Narrative

Block h6: imdrf device code a15 captures the reportable event of stent partial deployment.

Event Description

It was reported to boston scientific corporation that an ultraflex esophageal ng distal covered stent was to be implanted in the esophagus to treat esophageal stenosis during an esophageal stricture dilatation procedure performed on (b)(6) 2023.The patient's anatomy was not tortuous and was dilated prior to stent placement.During the procedure, the stent could not be deployed inside the patient.The stent was removed from the patient partially deployed on the delivery system, and a different device was used to complete the procedure.There were no patient complications reported as a result of this event, and the patient's condition after the procedure was reported to be stable.

Manufacturer Narrative

Block h6: imdrf device code a15 captures the reportable event of stent partial deployment.Block h10: the ultraflex esophageal ng distal covered stent and delivery system were received for analysis.Visual inspection found that the stent was partially deployed on the delivery system, and the shaft was kinked.Functional inspection related to the deployment of the stent was performed by pulling the finger ring, and it was found that there was no resistance felt.No other damages were noted with the stent or the delivery system.Product analysis confirmed the reported event of partial stent deployment.The investigation concluded that the reported event and the additional investigation finding of shaft kinking were most likely procedural factors such as lesion characteristics, the handling of the device, and the technique used by the physician (force applied), which could have resulted in the damages encountered in the device and prevented the stent from fully deploying during the procedure.Therefore, a review and analysis of all available information indicated that the most probable cause is adverse event related to procedure.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 that an ultraflex esophageal ng distal covered stent was to be implanted in the esophagus to treat esophageal stenosis during an esophageal stricture dilatation procedure performed on (b)(6) 2023.The patient's anatomy was not tortuous and was dilated prior to stent placement.During the procedure, the stent could not be deployed inside the patient.The stent was removed from the patient partially deployed on the delivery system, and a different device was used to complete the procedure.There were no patient complications reported as a result of this event, and the patient's condition after the procedure was reported to be stable.

• 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: 18285879
• MDR Text Key: 329967507
• Report Number: 3005099803-2023-06515
• Device Sequence Number: 1
• Product Code: ESW
• UDI-Device Identifier: 08714729716150
• UDI-Public: 08714729716150
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 01/16/2024

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: 12/17/2023
• Device Model Number: M00513730
• Device Catalogue Number: 1373
• Device Lot Number: 0028575591
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/16/2023
• Initial Date FDA Received: 12/07/2023
• Supplement Dates Manufacturer Received: 12/22/2023
• Supplement Dates FDA Received: 01/16/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/17/2021
• 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 Age: 59 YR
• Patient Sex: Male
• Patient Weight: 80 KG