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); Activation Failure (3270)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/24/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).An ultraflex tracheobronchial covered distal release stent and delivery system were received for analysis.The stent was received partially deployed.Visual examination of the returned device found the stent was not fully expanded ,and was deformed in the proximal section.The finger ring was detached from the crocheted suture.Functional evaluation revealed that it was possible to deploy the stent by holding the handle hub in the palm of one hand, grasping the crocheted suture that binds to the delivery system shaft and gradually releasing the stent from the delivery system.The outer diameter (od) of the stent ad the stent length were measured, and were found to be within specification.No other issues were noted to the stent and delivery system.The reported event of stent partially deployed was confirmed.The investigation concluded that the reported event, and the observed failures were likely due to factors encountered during the procedure.It may be that how the device was handled, or manipulated during the procedure, the rotation of the stent during the deployment and/or the anatomy of the patient, limited the performance of the device and contributed to the stent partial deployment, stent deformed, and stent failure to expand.Also, it is possible that excessive force was applied to the device during deployment, and caused the detachment of the finger ring from the crocheted suture.Therefore, a review and analysis of all available information indicated the most probable cause is adverse event related to procedure.A review of the device history record (dhr) was performed, and confirmed that this device met all material, assembly, and performance specifications at the time of release for distribution.A labeling review was performed, and from the information available, this device was used per the directions for use (dfu) / product label.

Event Description

It was reported to boston scientific corporation that an ultraflex tracheobronchial covered distal release stent was to be implanted in the lung to treat a gastric cancer that invaded the trachea, and caused a fistula during a tracheoesophageal fistula with stent placement procedure performed on (b)(6) 2020.According to the complainant, during the procedure, 70% of the black stent deployment suture was pulled out, and the stent was partially released.Reportedly, the remaining 30% of the deployment suture could not be pulled.The stent was removed from the patient partially deployed on the delivery system, and the procedure was completed with a different device.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 a reportable event based on the investigation finding of stent deformed and stent failure to expand.

• 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: 10683840
• MDR Text Key: 211487696
• Report Number: 3005099803-2020-04644
• 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: 10/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/02/2020
• Device Model Number: M00564750
• Device Catalogue Number: 6475
• Device Lot Number: 0022598270
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/09/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/23/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/03/2018
• 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: 63 YR
• Patient Weight: 75