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

Model Number M00564870

Device Problem Activation Failure (3270)

Patient Problem Hypoxia (1918)

Event Date 08/09/2023

Event Type  Injury  

Manufacturer Narrative

Block e1: initial reporter facility name: (b)(6) hospital.Block h6: imdrf device code a150101 captures the reportable event of stent failure to expand.Imdrf patient code e0726 captures the reportable event of hypoxia.Imdrf impact code f23 captures the reportable event of "rescue" performed to address the patient complication.

Event Description

It was reported to boston scientific corporation that an ultraflex tracheobronchial distal release covered stent was to be implanted in the main airway to treat a trachea fistula due to a malignant tumor during a stent implantation procedure performed on (b)(6) 2023.The patient's anatomy was not tortuous and was dilated prior to stent placement.During the procedure, the stent was fully deployed; however, the stent did not expand.The stent was removed from the patient using biopsy forceps.The patient experienced a significant decrease in oxygen levels and a "rescue" was performed after the stent was removed.The procedure was completed with another ultraflex tracheobronchial stent.The patient's condition at the conclusion of the procedure was reported to be stable.A photo of the device provided by the complainant shows that the stent did not 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: 17592011
• MDR Text Key: 321621565
• Report Number: 3005099803-2023-04485
• 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
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/24/2024
• Device Model Number: M00564870
• Device Catalogue Number: 6487
• Device Lot Number: 0029277973
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/11/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/25/2022
• 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: 57 YR
• Patient Sex: Male
• Patient Weight: 70 KG