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

Model Number M00564860

Device Problems Break (1069); Unraveled Material (1664); Positioning Problem (3009)

Patient Problems Injury (2348); Insufficient Information (4580)

Event Date 12/22/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).The device has been received for analysis.Upon 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 december 23, 2020 that an ultraflex tracheobronchial distal release covered stent was to be implanted to treat a malignant airway tumor in the main trachea during a tracheal stent implantation procedure performed on (b)(6) 2020.Reportedly, the patient's anatomy was not tortuous prior to stent placement.According to the complainant, during the procedure, the stent was fully deployed inside the patient but in an incorrect location.The physician pulled the green retention suture to adjust the position of the stent but the stent suture broke and the stent unraveled.The stent was removed from the patient and the procedure was rescheduled.Reportedly, the patient was hospitalized for observation 1 to 2 weeks until another procedure was performed and a non-bsc device was implanted.Reportedly, the patient had minor airway mucosa damage that did not require any medical intervention.The patient's condition at the conclusion of the procedure was reported to be stable.

Manufacturer Narrative

Block h6: medical device problem code a0401 captures the reportable event of stent suture break.Medical device problem code a1502 captures the reportable event of stent positioning issue.Medical device problem code a040508 captures the reportable event of stent unraveled material.Block h10: a deployed ultraflex tracheobronchial covered stent and deployment suture were received for analysis; the delivery system was not returned.Visual examination of the returned device found the stent was returned unraveled and the green suture was broken.The stent length was measured and was found not to be within specification as the stent was returned unraveled.No other issues with the stent was noted.The reported event of stent suture break and stent unraveled material were confirmed during visual examination.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 technique used by the user and the incorrect location of the deployed stent could have contributed to the stent suture to break and the stent to unravel when the physician likely pulled the green retention suture to adjust the position of the stent 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.A labeling review was performed, and from the information available, this device was used per the instructions for use (ifu)/ product label.

Event Description

It was reported to boston scientific corporation on (b)(6) 2020 that an ultraflex tracheobronchial distal release covered stent was to be implanted to treat a malignant airway tumor in the main trachea during a tracheal stent implantation procedure performed on (b)(6) 2020.Reportedly, the patient's anatomy was not tortuous prior to stent placement.According to the complainant, during the procedure, the stent was fully deployed inside the patient but in an incorrect location.The physician pulled the green retention suture to adjust the position of the stent but the stent suture broke and the stent unraveled.The stent was removed from the patient and the procedure was rescheduled.Reportedly, the patient was hospitalized for observation 1 to 2 weeks until another procedure was performed and a non-bsc device was implanted.Reportedly, the patient had minor airway mucosa damage that did not require any medical intervention.The patient's condition at the conclusion of the procedure was reported to be stable.Additional information received on january 13, 2021: according to the complainant, the patient was hospitalized prior to the stent placement procedure and remained in the hospital for 1 to 2 weeks where routine observation was performed until another procedure was performed to implant a non-bsc device.

• 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: 11166917
• MDR Text Key: 226741986
• Report Number: 3005099803-2021-00099
• 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: 02/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/28/2022
• Device Model Number: M00564860
• Device Catalogue Number: 6486
• Device Lot Number: 0025542731
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2021
• Date Manufacturer Received: 01/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 57 YR
• Patient Weight: 84