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

Model Number M00513850

Device Problems Positioning Failure (1158); Failure to Advance (2524); Material Deformation (2976)

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

Event Date 03/31/2023

Event Type  malfunction  

Manufacturer Narrative

Block a2: patient's exact age is unknown; however, it was reported that the patient was over the age of 18.Block h6: impact code f1001 is being used to capture the reportable issue of aborted/cancelled procedure.

Event Description

It was reported to boston scientific corporation on april 12, 2023, that an ultraflex esophageal ng proximal release covered stent was implanted to treat esophageal stenosis due to esophageal cancer during an esophageal stent placement procedure performed on (b)(6) 2023.The patient anatomy was tortuous and not dilated prior to stent placement, during the procedure, the device could not be advanced through the stenosis.Dilation was attempted and a new maneuver was performed to implant the stent.However, the stent was unable to cross the stenosis even after several attempts and the distal part of the delivery shaft was noted to be bent.The stent was removed from the patient fully covered by the stent deployment suture, and the procedure was not completed due to this event.There were no patient complications reported as a result of this event.The patient condition following the procedure was reported to be stable.

Manufacturer Narrative

Block a2: patient's exact age is unknown; however, it was reported that the patient was over the age of 18.Block h6: impact code f1001 is being used to capture the reportable issue of aborted/cancelled procedure.Block h10: the ultraflex esophageal ng proximal covered stent and delivery system were received for analysis.Visual inspection revealed that the stent was partially deployed, and the shaft was bent.The outer diameter of the stent delivery system was measured and was found to be within specifications.No other damage was noted to the stent or the delivery system.Product analysis confirmed the reported event of shaft bent.However, the reported event of the delivery system being difficult to cross lesion could not be confirmed because this event occurred during the procedure and was not possible to replicate in the laboratory of analysis.The investigation concluded that the reported events and the observed failure were most likely due to procedural factors, such as lesion characteristics, handling of the device, and the technique used in several attempts to cross the lesion.These procedural factors may have limited the performance of the device and contributed to stent partial deployment.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.Block h11: correction to the initial mdr in block h6 (device codes).

Event Description

It was reported to boston scientific corporation on (b)(6) 2023, that an ultraflex esophageal ng proximal release covered stent was implanted to treat esophageal stenosis due to esophageal cancer during an esophageal stent placement procedure performed on (b)(6) 2023.The patient anatomy was tortuous and not dilated prior to stent placement, during the procedure, the device could not be advanced through the stenosis.Dilation was attempted and a new maneuver was performed to implant the stent.However, the stent was unable to cross the stenosis even after several attempts and the distal part of the delivery shaft was noted to be bent.The stent was removed from the patient fully covered by the stent deployment suture, and the procedure was not completed due to this event.There were no patient complications reported as a result of this event.The patient condition following 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: 16896525
• MDR Text Key: 314852055
• Report Number: 3005099803-2023-02325
• Device Sequence Number: 1
• Product Code: ESW
• UDI-Device Identifier: 08714729716075
• UDI-Public: 08714729716075
• 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,Followup
• Report Date: 07/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M00513850
• Device Catalogue Number: 1385
• Device Lot Number: 0029916739
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/29/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/09/2022
• 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