RELAY NBS PRO THORACIC STENT-GRAFT
Report
- Report Number
- 2247858-2021-00053
- Event Type
- Death
- Date Received
- June 11, 2021
- Date of Event
- April 6, 2021
- Report Date
- October 12, 2021
- Manufacturer
- BOLTON MEDICAL, INC.
- Product Code
- MIH
- PMA / PMN Number
- P110038
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NL
- Reporter Occupation
- OTHER
Narratives
BOLTON MEDICAL IS VOLUNTARILY REPORTING AN EVENT RELATED TO A RELAY NBS PRO DEVICE. THE RELAY NBS PRO 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 IN 2012 (P110038). THE EVENT OCCURRED IN THE NETHERLANDS. EMAIL (DATED MAY 20, 2021) FROM TERUMO AORTIC CLINICAL STUDY MANAGER STATED "PLEASE BE ADVISED SITE HAVE CONFIRMED THE EVENT FOR SUBJECT 015-015 IS UNRELATED TO THE DEVICE." THIS WAS BASED ON RESPONSE PROVIDED TO THE TERUMO AORTIC CLINICAL STUDY MANAGER BY THE SITE STATING, "AFTER CONSULTING WITH DR. HOKSBERGEN, THE DEVICE RELATIONSHIP IS "UNRELATED"."
PUNCTURED LEFT VENTRICLE WITH STIFF GUIDEWIRE > VENTRICLE FIBRILLATION. THORACOTOMIA, SUTURING OF LEFT VENTRICLE, DEFIBRILLATION, 1HR COMPRESSIONS - PATIENT DEATH.
BOLTON MEDICAL IS VOLUNTARILY REPORTING AN EVENT RELATED TO A RELAY NBS PRO DEVICE. THE RELAY NBS PRO 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 IN 2012 (P110038). THE EVENT OCCURRED IN (B)(6).
PUNCTURED LEFT VENTRICLE WITH STIFF GUIDEWIRE > VENTRICLE FIBRILLATION. THORACOTOMIA, SUTURING OF LEFT VENTRICLE, DEFIBRILLATION, 1HR COMPRESSIONS - PATIENT DEATH.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 880512 | RELAY NBS PRO THORACIC STENT-GRAFT | STENT, ENDOVASCULAR GRAFT, AORTIC | MIH | BOLTON MEDICAL, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 99 YR | Death |