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

Model Number M00564850

Device Problems Break (1069); Unraveled Material (1664); Activation Failure (3270)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/02/2020

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 (b)(6) 2020, that an ultraflex tracheobronchial covered distal release stent was to be implanted to treat an airway stenosis during an airway dilatation with stent placement procedure performed on (b)(6) 2020.According to the complainant, during the procedure, the black deployment suture was fractured and the stent unraveled.The stent 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.A photo of the device was provided by the complainant after the procedure, and it shows the stent was not fully expanded, the green retention stent suture fell off of the stent, and the stent wire unraveled.

Event Description

It was reported to boston scientific corporation on september 02, 2020, that an ultraflex tracheobronchial covered distal release stent was to be implanted to treat an airway stenosis during an airway dilatation with stent placement procedure performed on (b)(6) 2020.According to the complainant, during the procedure, the black deployment suture was fractured and the stent unraveled.The stent 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.A photo of the device was provided by the complainant after the procedure, and it shows the stent was not fully expanded, the green retention stent suture fell off of the stent, and the stent wire unraveled.

Manufacturer Narrative

Block h6: problem code 1664 captures the reportable event of stent unraveled and stent suture fell off of the stent.Problem code 3270 captures the reportable event of stent failure to expand.Block h10: an ultraflex tracheobronchial covered stent was received for analysis; the delivery system was not returned.Visual examination of the returned device found the stent not fully expanded.The stent suture was returned unraveled.The green suture was detached and was not returned.The length of the stent was out of specification due to the unraveled condition.The outer diameter (od) of the stent was measured and was found to be within specification.No other issues were noted to the stent.The reported event of stent unraveled material and stent failure to expand were confirmed.The stent was returned unraveled and not fully expanded.The reported event of stent deployment suture break was not confirmed; the delivery system was not returned.The investigation concluded that the reported events and the observed failures were most likely due to factors encountered during the procedure.It may be how the device was handled or manipulated, the technique used by the physician and/ or the anatomy of the patient, limited the performance of the device and contributed to stent unraveled and stent failure to expand.Therefore, a review and analysis of all available information indicated the most probable cause is adverse event related to the 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 directions for use (dfu) / 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: 10589553
• MDR Text Key: 208629023
• Report Number: 3005099803-2020-04208
• 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: 10/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/02/2020
• Device Model Number: M00564850
• Device Catalogue Number: 6485
• Device Lot Number: 0022743117
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2020
• Date Manufacturer Received: 10/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 58 YR
• Patient Weight: 120