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

Model Number M00513750

Device Problems Failure to Advance (2524); Activation, Positioning or Separation Problem (2906)

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

Event Date 01/20/2023

Event Type  malfunction  

Manufacturer Narrative

The initial reporter facility name (b)(6) hospital.Imdrf device code a15 captures the reportable event of stent partially deployed.

Event Description

It was reported to boston scientific corporation on february 15, 2023, that an ultraflex esophageal ng distal release covered stent was to be implanted in the esophagus to treat an invasive 9 cm stenosis due to esophageal cancer during an endoscopic esophageal stent implantation procedure performed on (b)(6) 2023.The patient's anatomy was tortuous and was not dilated prior to stent placement.During the procedure, the physician was having difficulty reaching the posterior segment of the stenosis, so the lesion was dilated with an endoscope.The ultraflex esophageal stent was then attempted to be deployed, but it could not be deployed normally despite repeatedly rotating the device.The stent was removed from the patient partially deployed on the delivery system, and another ultraflex esophageal stent was implanted to complete the procedure.There were no reported patient complications as a result of this event.The patient's condition following the procedure was reported to be stable.

Event Description

It was reported to boston scientific corporation on february 15, 2023, that an ultraflex esophageal ng distal release covered stent was to be implanted in the esophagus to treat an invasive 9 cm stenosis due to esophageal cancer during an endoscopic esophageal stent implantation procedure performed on (b)(6) 2023.The patient's anatomy was tortuous and was not dilated prior to stent placement.During the procedure, the physician was having difficulty reaching the posterior segment of the stenosis, so the lesion was dilated with an endoscope.The ultraflex esophageal stent was then attempted to be deployed, but it could not be deployed normally despite repeatedly rotating the device.The stent was removed from the patient partially deployed on the delivery system, and another ultraflex esophageal stent was implanted to complete the procedure.There were no reported patient complications as a result of this event.The patient's condition following the procedure was reported to be stable.

Manufacturer Narrative

Block e1: the initial reporter facility name is the sixth affiliated hospital of (b)(6) university.Block h6: imdrf device code a15 captures the reportable event of stent partially deployed.Block h10: the ultraflex esophageal ngf distal covered stent was returned, but the delivery system was not received for analysis.Visual inspection revealed no damage to the stent.Product analysis did not confirm the reported device malfunction of stent partially deployed because inspection of the returned stent revealed that the stent was completely deployed, and no damages were noted.Moreover, the reported malfunction of delivery system difficult to cross lesion cannot be confirmed as it occurred during the procedure and was not possible to replicate in the laboratory.Therefore, review and analysis of all available information indicated that the most probable cause is no problem detected.A product labeling review identified that the device was used per the instructions for use (ifu)/product label.

• 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: 16489410
• MDR Text Key: 310788090
• Report Number: 3005099803-2023-01148
• Device Sequence Number: 1
• Product Code: ESW
• UDI-Device Identifier: 08714729649113
• UDI-Public: 08714729649113
• 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: 05/02/2023

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: 01/25/2023
• Device Model Number: M00513750
• Device Catalogue Number: 1375
• Device Lot Number: 0026687908
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/15/2023
• Initial Date FDA Received: 03/06/2023
• Supplement Dates Manufacturer Received: 04/12/2023
• Supplement Dates FDA Received: 05/02/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/25/2021
• 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: 58 YR
• Patient Sex: Male
• Patient Weight: 75 KG