MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ULTRAFLEX TRACHEOBRONCHIAL; PROSTHESIS, TRACHEAL, EXPANDABLE

Model Number M00576590

Device Problem Activation, Positioning or Separation Problem (2906)

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

Event Date 03/02/2023

Event Type  malfunction  

Manufacturer Narrative

Initial reporter address: (b)(6).Imdrf device code a15 captures the reportable event of stent partially deployed.

Event Description

It was reported to boston scientific corporation on march 02, 2023, that an ultraflex tracheobronchial distal release covered stent was to be implanted in the trachea to relieve a 2cm airway obstruction caused by malignancy, during an airway stenting procedure performed on (b)(6) 2023.The patient's anatomy was not tortuous and was not dilated prior to stent placement.During the procedure, the stent could not be fully deployed.The stent was removed from the patient partially deployed.And the procedure was completed using another ultraflex tracheobronchial stent.There were no patient complications as a result of this event.

Event Description

It was reported to boston scientific corporation on march 02, 2023, that an ultraflex tracheobronchial distal release covered stent was to be implanted in the trachea to relieve a 2cm airway obstruction caused by malignancy during an airway stenting procedure performed on (b)(6) 2023.The patient's anatomy was not tortuous and was not dilated prior to stent placement.During the procedure, the stent could not be fully deployed.The stent was removed from the patient partially deployed and the procedure was completed using another ultraflex tracheobronchial stent.There were no patient complications as a result of this event.

Manufacturer Narrative

Block e1: initial reporter address 2: (b)(6).Block h6: imdrf device code a15 captures the reportable event of stent partially deployed.An ultraflex tracheobronchial distal release covered stent and delivery system were received for analysis.The stent was received partially deployed.Visual examination of the returned device found the shaft bent in the distal section.The deployment suture was inspected, and no damages or knots were noted.Functional examination was performed by holding the handle hub in the palm of one hand, grasping and retracting the finger ring with the other hand, and the stent was gradually deployed.No other problems were noted to the stent and delivery system.The reported event of stent partially deployed was confirmed.The investigation concluded that the reported event of stent partially deployed, and the observed failure of shaft bent were likely due to factors encountered during the procedure.It may be that lesion characteristics, how the device was handled and/or the technique used by the physician (force applied), limited the performance of the device and contributed to the reported event and the observed failure.Taking all available information into consideration, the investigation concluded that the reported event and observed failures were likely due to factors encountered during the procedure.Therefore, a review and analysis of the all the available information indicated that the most probable cause is adverse event related to procedure.

• Brand Name: ULTRAFLEX TRACHEOBRONCHIAL
• Type of Device: PROSTHESIS, TRACHEAL, EXPANDABLE
• 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: 16589505
• MDR Text Key: 311981621
• Report Number: 3005099803-2023-01442
• Device Sequence Number: 1
• Product Code: JCT
• UDI-Device Identifier: 08714729842392
• UDI-Public: 08714729842392
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K141584
• 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: 07/11/2023

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: 09/30/2023
• Device Model Number: M00576590
• Device Catalogue Number: 56598
• Device Lot Number: 0028115776
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/02/2023
• Initial Date FDA Received: 03/22/2023
• Supplement Dates Manufacturer Received: 06/26/2023
• Supplement Dates FDA Received: 07/11/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/30/2021
• 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: 56 YR
• Patient Sex: Male
• Patient Weight: 62 KG
• Patient Race: Asian