RELAY NBS THORACIC STENT-GRAFT WITH PLUS DELIVERY SYSTEM
Report
- Report Number
- 2247858-2023-00072
- Event Type
- Malfunction
- Date Received
- March 22, 2023
- Date of Event
- February 21, 2023
- Report Date
- June 8, 2023
- Manufacturer
- BOLTON MEDICAL, INC.
- Product Code
- MIH
- PMA / PMN Number
- P110038
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
BOLTON MEDICAL IS VOLUNTARILY REPORTING AN EVENT RELATED TO A RELAY NBS THORACIC STENT-GRAFT WITH PLUS DELIVERY SYSTEM. THE RELAY NBS PLUS DEVICE IS NOT MARKETED IN THE US, HOWEVER IT IS SIMILAR TO THE RELAY THORACIC STENT GRAFT WITH PLUS DELIVERY SYSTEM APPROVED FOR SALE IN THE US (P110038). THE EVENT OCCURRED IN CHINA.
BOLTON MEDICAL IS VOLUNTARILY REPORTING AN EVENT RELATED TO A RELAY NBS THORACIC STENT-GRAFT WITH PLUS DELIVERY SYSTEM. THE RELAY NBS PLUS DEVICE IS NOT MARKETED IN THE US, HOWEVER IT IS SIMILAR TO THE RELAY THORACIC STENT GRAFT WITH PLUS DELIVERY SYSTEM APPROVED FOR SALE IN THE US (P110038). THE EVENT OCCURRED IN CHINA.
PREPARATION OF THE PROCEDURE WAS ALL NORMAL. WHEN THE DELIVERY SYSTEM WAS INSERTED INTO THE ARTERY VESSEL, THE TIP COLLAPSED FROM THE STEEL AND DETACHED WITH THE DELIVERY SYSTEM. THE TIP WAS REMOVED BY SURGERY. PATIENT OUTCOME - "UNKNOWN.".
PREPARATION OF THE PROCEDURE WAS ALL NORMAL. WHEN THE DELIVERY SYSTEM WAS INSERTED INTO THE ARTERY VESSEL, THE TIP COLLAPSED FROM THE STEEL AND DETACHED WITH THE DELIVERY SYSTEM. THE TIP WAS REMOVED BY SURGERY. PATIENT OUTCOME - "UNKNOWN."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 828021 | RELAY NBS THORACIC STENT-GRAFT WITH PLUS DELIVERY SYSTEM | STENT, ENDOVASCULAR GRAFT, AORTIC | MIH | BOLTON MEDICAL, INC. | B210710012 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 62 YR | Female | Required Intervention |