RELAY PRO THORACIC STENT-GRAFT SYSTEM
Report
- Report Number
- 2247858-2021-00132
- Event Type
- Malfunction
- Date Received
- December 28, 2021
- Date of Event
- December 14, 2021
- Report Date
- May 4, 2022
- Manufacturer
- BOLTON MEDICAL, INC.
- Product Code
- MIH
- PMA / PMN Number
- P200045
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SZ
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
BOLTON MEDICAL IS VOLUNTARILY REPORTING A DEVICE MALFUNCTION RELATED TO A CUSTOM RELAY TRIPLE BRANCH THORACIC STENT-GRAFT SYSTEM. THE CUSTOM MADE RELAY TRIPLE BRANCH THORACIC STENT- GRAFT SYSTEM USED IN THIS CASE IS NOT APPROVED FOR SALE IN THE US, HOWEVER THE DELIVERY SYSTEM IS SIMILAR TO THE RELAY PRO DELIVERY SYSTEM APPROVED FOR SALE IN THE US (P200045). THE CUSTOM RELAY TRIPLE BRANCH RELATED EVENT OCCURRED IN GERMANY.
BOLTON MEDICAL IS VOLUNTARILY REPORTING A DEVICE MALFUNCTION RELATED TO A CUSTOM RELAY TRIPLE BRANCH THORACIC STENT-GRAFT SYSTEM. THE CUSTOM MADE RELAY TRIPLE BRANCH THORACIC STENT- GRAFT SYSTEM USED IN THIS CASE IS NOT APPROVED FOR SALE IN THE US, HOWEVER THE DELIVERY SYSTEM IS SIMILAR TO THE RELAY PRO DELIVERY SYSTEM APPROVED FOR SALE IN THE US ((B)(4)). THE CUSTOM RELAY TRIPLE BRANCH RELATED EVENT OCCURRED IN (B)(6).
THE GRAFT DID NOT COME OUT OF THE OUTER SHEATH. THE DEVICE WAS POSITIONED INTO THE RIGHT POSITION IN THE DESCENDENT FOR SCREWING OUT THE GRAFT WITH THE INNER SHEATH. CONTROL WHEEL WAS ON POSITION 1 AND DR. SEELOS STARTED TO TURN THE DEPLOYMENT GRIP. WITH THE SECOND TURN A NOISE WAS HEARD (AS IF SOMETHING WAS BROKEN) COMING FROM THE DEPLOYMENT SYSTEM AND THE TIP WAS PUSHED FORWARD APPROXIMATELY 2-3 CM, BUT THE GRAFT ITSELF STAYED IN THE OUTER SHEATH IN THE HOME POSITION. WE THEN DECIDED TO DISCONTINUE THE INTERVENTION. TO GET THE DEVICE OUT OF THE PATIENT'S BODY WE TRIED TO REMOVE THE INNER SHEATH INTO THE OUTER SHEATH. WITH A LITTLE GAP BETWEEN THE END OF OUTER SHEATH AND THE TIP THE DEVICE WAS SUCCESSFULLY REMOVED. THE INNER SHEATH WAS STILL CLAMPED UNDER THE TIP CONE. DR. SEELOS REMOVED THE INNER SHEATH FROM THE TIP CONE JUST TO CHECK IF ANYTHING CAN BE MADE. WE ONLY SAW THAT THE TIP RELEASE WAS STILL IN THE ORIGINAL POSITION AND WE STOPPED THE SURGERY. PATIENT OUTCOME - "PATIENT WAS NOT HURT BECAUSE OF THIS INCIDENT, BUT ALL THE NECESSARY ACCESSES WERE PREPARED (EXPOSURE OF THE 2 GROINS AND THE 2 CAROTIDS)."
THE GRAFT DID NOT COME OUT OF THE OUTER SHEATH. THE DEVICE WAS POSITIONED INTO THE RIGHT POSITION IN THE DESCENDENT FOR SCREWING OUT THE GRAFT WITH THE INNER SHEATH. CONTROL WHEEL WAS ON POSITION 1 AND DR. SEELOS STARTED TO TURN THE DEPLOYMENT GRIP. WITH THE SECOND TURN A NOISE WAS HEARD (AS IF SOMETHING WAS BROKEN) COMING FROM THE DEPLOYMENT SYSTEM AND THE TIP WAS PUSHED FORWARD APPROXIMATELY 2-3 CM, BUT THE GRAFT ITSELF STAYED IN THE OUTER SHEATH IN THE HOME POSITION. WE THEN DECIDED TO DISCONTINUE THE INTERVENTION. TO GET THE DEVICE OUT OF THE PATIENT'S BODY WE TRIED TO REMOVE THE INNER SHEATH INTO THE OUTER SHEATH. WITH A LITTLE GAP BETWEEN THE END OF OUTER SHEATH AND THE TIP THE DEVICE WAS SUCCESSFULLY REMOVED. THE INNER SHEATH WAS STILL CLAMPED UNDER THE TIP CONE. DR. SEELOS REMOVED THE INNER SHEATH FROM THE TIP CONE JUST TO CHECK IF ANYTHING CAN BE MADE. WE ONLY SAW THAT THE TIP RELEASE WAS STILL IN THE ORIGINAL POSITION AND WE STOPPED THE SURGERY. PATIENT OUTCOME - "PATIENT WAS NOT HURT BECAUSE OF THIS INCIDENT, BUT ALL THE NECESSARY ACCESSES WERE PREPARED (EXPOSURE OF THE 2 GROINS AND THE 2 CAROTIDS)."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1989466 | RELAY PRO THORACIC STENT-GRAFT SYSTEM | STENT, ENDOVASCULAR GRAFT, AORTIC | MIH | BOLTON MEDICAL, INC. | 2111100121 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 62 YR | Male |