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

Model Number M00564520

Device Problems Positioning Failure (1158); Material Deformation (2976)

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

Event Date 01/28/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).An ultraflex tracheobroncial covered distal release stent and delivery system were received for analysis.Visual examination of the returned device found the stent was partially deployed and the stent wire was damaged.The shaft was returned damage near the proximal section of the deployment suture and was kinked in two sections near the tip.Functional evaluation was performed and the shaft bowed.No other issues with the stent and delivery system were noted.The reported event of stent failure to deploy was confirmed as the stent was received partially deployed.The investigation concluded that the reported event and the observed failures were likely due to factors encountered during the procedure.It may be that the interaction with the bronchoscope, the technique used by the user and/or the patient anatomy (malignancy) could have caused the physician to feel some resistance, limited the performance of the device and contributed to stent partially deployed and stent damage.Also, the kink and the damage in the shaft could have been due to the attempted deployment and for this reason the stent could not deployed during the procedure.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.

Event Description

It was reported to boston scientific corporation that an ultraflex tracheobronchial uncovered distal release stent was to be implanted to treat a malignant stenosis in the middle segment of the bronchus during a stent placement procedure performed on (b)(6) 2021.Reportedly, the patient's anatomy was not tortuous and was not dilated prior to stent placement.It was reported that during the procedure, the stent could not deploy.Reportedly, the stent was fully covered by the stent deployment suture 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: this event has been deemed an mdr reportable event based on investigation result which revealed the stent wire was damaged.

• 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: 11602019
• MDR Text Key: 243403123
• Report Number: 3005099803-2021-01409
• 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: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/10/2021
• Device Model Number: M00564520
• Device Catalogue Number: 6452
• Device Lot Number: 0023326608
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/10/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/11/2019
• 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: 45 YR
• Patient Weight: 66