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

Model Number M00564830

Device Problem Activation Failure (3270)

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

Event Date 02/15/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4).The device has been received for analysis.Upon completion of the problem 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 february 16, 2022 that an ultraflex tracheobronchial covered distal release stent was to be implanted to treat a stenosis in the right bronchus during a stent placement procedure performed on (b)(6) 2022.During the procedure, the stent was deployed; however, after deployment it was noticed under imaging that the stent did not expand.The stent was removed from the patient and the procedure was completed with another ultraflex tracheobronchial stent of a different size.There were no patient complications as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.

Manufacturer Narrative

Block b5 has been updated with additional information received on march 17, 2022.Block h6: medical device problem code a150101 captures the reportable event of stent failure to expand.Block h10: an ultraflex tracheobronchial stent was received for analysis; the delivery system was not returned.Visual examination of the returned device found the stent was fully deployed and the stent suture was broken.No other issues were noted to the stent.The damaged noted to the stent suture was most likely due to procedural factors encountered during the procedure.It may be that manipulation of the device during stent withdrawal could have led to broken stent suture.The reported event of stent failure to expand was not confirmed; the stent was received completely deployed and fully expanded.Therefore, a review and analysis of all available information indicated the most probable cause is no problem detected.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 february 16, 2022 that an ultraflex tracheobronchial covered distal release stent was to be implanted to treat a stenosis in the right bronchus during a stent placement procedure performed on (b)(6) 2022.During the procedure, the stent was deployed; however, after deployment it was noticed under imaging that the stent did not expand.The stent was removed from the patient and the procedure was completed with another ultraflex tracheobronchial stent of a different size.There were no patient complications as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.Additional information received on march 17, 2022 the stent was implanted to treat a stricture produced by a malignant neoplasm.

• 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: 13764702
• MDR Text Key: 287910768
• Report Number: 3005099803-2022-01259
• 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: Other,Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Followup
• Report Date: 04/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/11/2022
• Device Model Number: M00564830
• Device Catalogue Number: 6483
• Device Lot Number: 0025841329
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/14/2022
• Supplement Dates Manufacturer Received: 03/16/2022
• Supplement Dates FDA Received: 04/05/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/11/2020
• 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 Outcome(s): Required Intervention
• Patient Age: 63 YR
• Patient Sex: Female
• Patient Weight: 59 KG