ULTRAFLEX TRACHEOBRONCHIAL
Report
- Report Number
- 3005099803-2024-00480
- Event Type
- Injury
- Date Received
- February 13, 2024
- Date of Event
- September 2, 2023
- Report Date
- September 10, 2024
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- JCT
- PMA / PMN Number
- K012883
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
BLOCK H6: IMDRF DEVICE CODE A040508 CAPTURES THE REPORTABLE EVENT OF A STENT'S UNRAVELED MATERIAL. BLOCK H11: AN ULTRAFLEX TRACHEOBRONCHIAL COVERED STENT WAS RECEIVED FOR ANALYSIS; THE DELIVERY SYSTEM WAS NOT RETURNED. VISUAL INSPECTION WAS PERFORMED AND FOUND THE STENT UNRAVELED. NO OTHER DAMAGES WERE NOTED TO THE DEVICE. PRODUCT ANALYSIS CONFIRMED THE REPORTED EVENT OF STENT UNRAVELED MATERIAL. THE DAMAGE NOTED TO THE STENT WAS MOST LIKELY DUE TO PROCEDURAL FACTORS ENCOUNTERED DURING PROCEDURE. IT MIGHT THE CHARACTERISTICS OF THE LESION, HANDLING OF THE DEVICE, THE TECHNIQUES USED BY THE PHYSICIAN, AND THE AMOUNT OF FORCE APPLIED TO THE DEVICE COULD HAVE RESULTED TO STENT UNRAVELING. THEREFORE, A REVIEW AND ANALYSIS OF ALL AVAILABLE INFORMATION INDICATED THE MOST PROBABLE CAUSE IS ADVERSE EVENT RELATED TO PROCEDURE.
BLOCK H6: IMDRF DEVICE CODE A040508 CAPTURES THE REPORTABLE EVENT OF A STENT'S UNRAVELED MATERIAL.
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN UNLTRAFLEX TRACHEOBRONCHIAL COVERED STENT WAS TO BE IMPLANTED IN THE LEFT MAIN BRANCH TO TREAT A MALIGNANT 14-80 CM TRACHEAL STENOSIS DURING TRACHEAL STENT IMPLANTATION UNDER A RIGID SCOPE PROCEDURE PERFORMED ON (B)(6) 2023. THE PATIENT'S ANATOMY WAS TORTUOUS AND WAS DILATED PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, THE STENT WAS SUCCESSFULLY DEPLOYED AND EXPANDED INSIDE THE PATIENT; HOWEVER, IT WAS FOUND THAT THE EDGE OF THE STENT WAS LOOSE AND UNHOOKED. THE STENT WAS REMOVED FROM THE PATIENT WITH FORCEPS, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER ULTRAFLEX TRACHEOBRONCHIAL STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT, AND THE PATIENT'S CONDITION AFTER THE PROCEDURE WAS REPORTED TO BE STABLE.
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN UNLTRAFLEX TRACHEOBRONCHIAL COVERED STENT WAS TO BE IMPLANTED IN THE LEFT MAIN BRANCH TO TREAT A MALIGNANT 14-80 CM TRACHEAL STENOSIS DURING TRACHEAL STENT IMPLANTATION UNDER A RIGID SCOPE PROCEDURE PERFORMED ON (B)(6) 2023. THE PATIENT'S ANATOMY WAS TORTUOUS AND WAS DILATED PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, THE STENT WAS SUCCESSFULLY DEPLOYED AND EXPANDED INSIDE THE PATIENT; HOWEVER, IT WAS FOUND THAT THE EDGE OF THE STENT WAS LOOSE AND UNHOOKED. THE STENT WAS REMOVED FROM THE PATIENT WITH FORCEPS, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER ULTRAFLEX TRACHEOBRONCHIAL STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT, AND THE PATIENT'S CONDITION AFTER THE PROCEDURE WAS REPORTED TO BE STABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 813315 | ULTRAFLEX TRACHEOBRONCHIAL | PROSTHESIS, TRACHEAL, EXPANDABLE | JCT | BOSTON SCIENTIFIC CORPORATION | M00564820 | 0029796895 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 58 YR | Male | Required Intervention |