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

Model Number M00564750

Device Problems Activation, Positioning or Separation Problem (2906); Material Deformation (2976); Appropriate Term/Code Not Available (3191)

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

Event Date 04/14/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.

Event Description

It was reported to boston scientific corporation on (b)(6) 2021 that an ultraflex tracheobronchial covered distal release stent was to be implanted to treat a malignant stenosis in the left principal bronchus during a transbronchoscopic bronchial stent implantation procedure performed on (b)(6) 2021.Reportedly, the patient's anatomy was not tortuous and was not dilated prior to stent placement.During the procedure, the black deployment suture became knotted and the stent could not fully deploy.The stent was partially covered by the deployment suture when it was removed from the patient.The procedure was cancelled due to device availability.Additionally, the patient chose to be treated at a different facility.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.

Event Description

It was reported to boston scientific corporation on (b)(6) 2021 that an ultraflex tracheobronchial covered distal release stent was to be implanted to treat a malignant stenosis in the left principal bronchus during a transbronchoscopic bronchial stent implantation procedure performed on (b)(6), 2021.Reportedly, the patient's anatomy was not tortuous and was not dilated prior to stent placement.During the procedure, the black deployment suture became knotted and the stent could not fully deploy.The stent was partially covered by the deployment suture when it was removed from the patient.The procedure was cancelled due to device availability.Additionally, the patient chose to be treated at a different facility.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.

Manufacturer Narrative

Block h6: medical device problem a27 is being used to capture the reportable issue of aborted/cancelled procedure.Block h10: an ultraflex tracheobronchial covered distal release delivery system was received for analysis; the stent was not returned.Visual inspection was performed and the shaft was found damaged and the stent deployment suture was knotted.No other issues with the delivery system were noted.The reported event of stent deployment suture knotted was confirmed via visual inspection; however, the reported event of stent partially deployed could not be confirmed as the stent was not returned.It is possible that the factors encountered during the procedure, the technique used by the physician, and/or the patient's anatomy caused the reported failure of black deployment suture knotted, contributing to the stent partial deployment.Also, it is possible that the interaction with the bronchoscope caused the damage noted in the shaft.Therefore, a review and analysis of all available information indicated the most probable cause is adverse event related to procedure.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.A labeling review was performed and, from the information available, this device was used per the instructions for use (ifu) / product label.

• Brand Name: ULTRAFLEX TRACHEOBRONCHIAL
• Type of Device: PROSTHESIS, TRACHEAL, EXPANDABLE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 11777475
• MDR Text Key: 249282121
• Report Number: 3005099803-2021-02038
• Device Sequence Number: 1
• Product Code: JCT
• Combination Product (y/n): N
• PMA/PMN Number: K012883
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 06/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/10/2022
• Device Model Number: M00564750
• Device Catalogue Number: 6475
• Device Lot Number: 0025581663
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/06/2021
• Date Manufacturer Received: 05/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 71 YR
• Patient Weight: 69