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

Model Number M00513840

Device Problems Activation, Positioning or Separation Problem (2906); Material Twisted/Bent (2981)

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

Event Date 12/06/2023

Event Type  malfunction  

Event Description

It was reported to boston scientific corporation that an ultraflex esophageal covered proximal release stent was to be implanted in the middle and lower esophagus to treat a malignant stenosis during esophageal stent placement procedure performed on (b)(6) 2023.The patient's anatomy was tortuous and was not dilated prior to stent placement.During the procedure, the proximal end has been deployed.However, the distal end of the stent could not be deployed.The 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 as a result of this event and the patient condition after the procedure was reported to be stable.

Manufacturer Narrative

Block h6: imdrf device code a15 captures the reportable event of stent partially deployed.

Manufacturer Narrative

Block d4 was updated based on the additional information received on january 15, 2024.Block h6: imdrf device code a15 captures the reportable event of stent partially deployed.Block h10: an ultraflex esophageal stent and delivery system were received for analysis.Visual inspection revealed that the stent was partially deployed.Functional testing related to the deployment of the stent was performed, by pulling the finger ring without problems and no resistance was felt.No other problems were noted with the stent or delivery system.A product labeling review identified that the device was used per the instructions for use (ifu) / product label.Based on the information available, the investigation concluded that the reported event of stent partially deployed can be confirmed.Most likely procedural factors such as lesion characteristics, handling of the device, and the technique used by the physician (force applied), could have resulted in the damages encountered in the device.Therefore, a review and analysis of all available information indicated that the most probable cause is adverse event related to procedure.

Event Description

It was reported to boston scientific corporation that an ultraflex esophageal covered proximal release stent was to be implanted in the middle and lower esophagus to treat a malignant stenosis during esophageal stent placement procedure performed on (b)(6) 2023.The patient's anatomy was tortuous and was not dilated prior to stent placement.During the procedure, the proximal end has been deployed.However, the distal end of the stent could not be deployed.The 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 as a result of this event and the patient 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: 18409733
• MDR Text Key: 331717286
• Report Number: 3005099803-2023-06935
• Device Sequence Number: 1
• Product Code: ESW
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/06/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/18/2023
• Device Model Number: M00513840
• Device Catalogue Number: 1384
• Device Lot Number: 0026990742
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/15/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/18/2021
• 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: 72 KG