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

Model Number M00564780

Device Problems Break (1069); Use of Device Problem (1670); Activation, Positioning or Separation Problem (2906)

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

Event Date 06/26/2023

Event Type  malfunction  

Event Description

It was reported to boston scientific corporation on (b)(6) 2023 that an ultraflex tracheobronchial covered distal stent was to be implanted to treat a benign stenosis in the left main bronchus during a stent placement procedure performed on (b)(6) 2023.The patient's anatomy was tortuous and was dilated prior to stent placement.During the procedure, the black deployment suture broke and the stent was unable to deploy.The stent was partially deployed on the delivery system when it was removed from the patient.The procedure was completed with another ultraflex tracheobronchial stent.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.Note: it was reported that the ultraflex tracheobronchial covered distal stent was to be implanted to treat a benign stenosis.However, per the ultraflex tracheobronchial stent system instructions for use (ifu), the stent is indicated for use in the treatment of tracheobronchial strictures produced by malignant neoplasms.The device is not indicated for the treatment of benign stenosis.

Manufacturer Narrative

Block e1: the initial reporter's address is (b)(6).Block h6: imdrf device code a15 captures the reportable event of stent partially deployed.

Manufacturer Narrative

Block e1: the initial reporter's address is (b)(6).Block h6: imdrf device code a15 captures the reportable event of stent partially deployed.Block h10: an ultraflex tracheobronchial covered distal stent was received for analysis; the delivery system was not returned.The stent was received fully deployed and expanded.Visual inspection was performed and no problems were noted to the stent.Product analysis did not confirm the reported events of stent partially deployed and stent deployment suture.A product labeling review identified that the device was not used in accordance with the instructions for use (ifu) / product label.The complainant reported that the ultraflex tracheobronchial stent was to be implanted to treat a benign stenosis.However, the ifu states, "the stent is indicated for use in the treatment of tracheobronchial strictures produced by malignant neoplasms." there is no indication of what the customer reported because only the stent was received completely deployed.Therefore, a review and analysis of all available information indicated the most probable cause is no problem detected.

Event Description

It was reported to boston scientific corporation on june 30, 2023 that an ultraflex tracheobronchial covered distal stent was to be implanted to treat a benign stenosis in the left main bronchus during a stent placement procedure performed on (b)(6) 2023.The patient's anatomy was tortuous and was dilated prior to stent placement.During the procedure, the black deployment suture broke and the stent was unable to deploy.The stent was partially deployed on the delivery system when it was removed from the patient.The procedure was completed with another ultraflex tracheobronchial stent.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.Note: it was reported that the ultraflex tracheobronchial covered distal stent was to be implanted to treat a benign stenosis.However, per the ultraflex tracheobronchial stent system instructions for use (ifu), the stent is indicated for use in the treatment of tracheobronchial strictures produced by malignant neoplasms.The device is not indicated for the treatment of benign stenosis.

• 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: 17368168
• MDR Text Key: 320074887
• Report Number: 3005099803-2023-03893
• Device Sequence Number: 1
• Product Code: JCT
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K012883
• 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: 09/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M00564780
• Device Catalogue Number: 6478
• Device Lot Number: 0030021007
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/25/2022
• 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
• Patient Age: 47 YR
• Patient Sex: Male
• Patient Weight: 60 KG