RELAY PRO NBS THORACIC STENT-GRAFT SYSTEM
Report
- Report Number
- 2247858-2024-00038
- Event Type
- Malfunction
- Date Received
- February 16, 2024
- Date of Event
- January 22, 2024
- Report Date
- May 17, 2024
- Manufacturer
- BOLTON MEDICAL, INC.
- Product Code
- MIH
- PMA / PMN Number
- P200045
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
BOLTON MEDICAL, INC. (D/B/A TERUMO AORTIC), HEREIN KNOWN AS THE "COMPANY", IS SUBMITTING THIS REPORT PURSUANT TO 21 CFR PART 803, HAS MADE REASONABLE EFFORTS TO OBTAIN COMPLETE INFORMATION, AND HAS PROVIDED AS MUCH AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT IS BASED ON INFORMATION OBTAINED BY THE COMPANY, WHICH MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE REGULATIONS. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN, UNAVAILABLE, OR NOT APPLICABLE. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY ANYONE THAT THE DEVICE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE A LEGAL ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY DEFECTS OR HAS MALFUNCTIONED, AS DEFINED FROM A LEGAL STANDPOINT. THESE WORDS ARE INCLUDED IN THE REPORT AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE CERTAIN REGULATIONS, TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REPORTING PURSUANT TO PART 803. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT.
BOLTON MEDICAL, INC. (D/B/A TERUMO AORTIC), HEREIN KNOWN AS THE "COMPANY", IS SUBMITTING THIS REPORT PURSUANT TO 21 CFR PART 803, HAS MADE REASONABLE EFFORTS TO OBTAIN COMPLETE INFORMATION, AND HAS PROVIDED AS MUCH AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT IS BASED ON INFORMATION OBTAINED BY THE COMPANY, WHICH MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE REGULATIONS. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN, UNAVAILABLE, OR NOT APPLICABLE. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY ANYONE THAT THE DEVICE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE A LEGAL ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY DEFECTS OR HAS MALFUNCTIONED, AS DEFINED FROM A LEGAL STANDPOINT. THESE WORDS ARE INCLUDED IN THE REPORT AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE CERTAIN REGULATIONS, TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REPORTING PURSUANT TO PART 803. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT.
"UNABLE TO DEPLOY THE STENT GRAFT: AFTER THE INNER SHEATH WAS ADVANCED OUT OF THE OUTER SHEATH AT CONTROLLER POSITION "1", THE POSITION OF THE RELAYPRO WAS FINALIZED. WHEN THE DEPLOYMENT GRIP WAS ROTATED COUNTERCLOCKWISE TO PULL DOWN THE INNER SHEATH AT CONTROLLER POSITION "2", THE INNER SHEATH COULD NOT BE PULLED DOWN AND THE STENT GRAFT WAS NOT DEPLOYED. THE INNER SHEATH APPEARED TO STILL BE ENGAGED IN THE DELIVERY SYSTEM TIP, AND THE TIP EXHIBITED A MOTION AS IF IT WAS BENDING INTO A CHEVRON SHAPE. AFTER RE-CONFIRMING THAT THE CONTROLLER POSITION WAS "2", ATTEMPTS WERE MADE TO PULL DOWN THE INNER SHEATH BY MOVING THE ENTIRE DELIVERY SYSTEM CENTRALLY AND PERIPHERALLY, AND BY SLIDING THE DEPLOYMENT GRIP FORWARD, BUT THE INNER SHEATH COULD NOT BE PULLED DOWN. AFTER THAT, THE DEPLOYMENT GRIP WAS ROTATED AGAIN TO DEPLOY THE STENT GRAFT, AND THE INNER SHEATH COULD BE RELEASED ALLOWING THE STENT GRAFT TO BE DEPLOYED. ALTHOUGH THERE WERE DEPLOYMENT DIFFICULTIES, THE STENT GRAFT WAS SUCCESSFULLY IMPLANTED IN THE INTENDED POSITION, AND THE PROCEDURE WAS COMPLETED AS USUAL WITH NO ADDITIONAL TREATMENT. OPERATION TYPE: TEVAR. BLOOD LOSS: AMOUNT IS SMALL IF ANY. IMAGE AVAILABLE. PRE-CASE PLAN AVAILABLE. NO ADDITIONAL INFORMATION AVAILABLE. (TC# (B)(4))" PATIENT OUTCOME: "NO HEALTH DAMAGE TO THE PATIENT."
"UNABLE TO DEPLOY THE STENT GRAFT: AFTER THE INNER SHEATH WAS ADVANCED OUT OF THE OUTER SHEATH AT CONTROLLER POSITION "1", THE POSITION OF THE RELAYPRO WAS FINALIZED. WHEN THE DEPLOYMENT GRIP WAS ROTATED COUNTERCLOCKWISE TO PULL DOWN THE INNER SHEATH AT CONTROLLER POSITION "2", THE INNER SHEATH COULD NOT BE PULLED DOWN AND THE STENT GRAFT WAS NOT DEPLOYED. THE INNER SHEATH APPEARED TO STILL BE ENGAGED IN THE DELIVERY SYSTEM TIP, AND THE TIP EXHIBITED A MOTION AS IF IT WAS BENDING INTO A CHEVRON SHAPE. AFTER RE-CONFIRMING THAT THE CONTROLLER POSITION WAS "2", ATTEMPTS WERE MADE TO PULL DOWN THE INNER SHEATH BY MOVING THE ENTIRE DELIVERY SYSTEM CENTRALLY AND PERIPHERALLY, AND BY SLIDING THE DEPLOYMENT GRIP FORWARD, BUT THE INNER SHEATH COULD NOT BE PULLED DOWN. AFTER THAT, THE DEPLOYMENT GRIP WAS ROTATED AGAIN TO DEPLOY THE STENT GRAFT, AND THE INNER SHEATH COULD BE RELEASED ALLOWING THE STENT GRAFT TO BE DEPLOYED. ALTHOUGH THERE WERE DEPLOYMENT DIFFICULTIES, THE STENT GRAFT WAS SUCCESSFULLY IMPLANTED IN THE INTENDED POSITION, AND THE PROCEDURE WAS COMPLETED AS USUAL WITH NO ADDITIONAL TREATMENT. OPERATION TYPE: TEVAR; BLOOD LOSS: AMOUNT IS SMALL IF ANY. IMAGE AVAILABLE. PRE-CASE PLAN AVAILABLE. NO ADDITIONAL INFORMATION AVAILABLE (B)(4). PATIENT OUTCOME: "NO HEALTH DAMAGE TO THE PATIENT."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 386761 | RELAY PRO NBS THORACIC STENT-GRAFT SYSTEM | STENT, ENDOVASCULAR GRAFT, AORTIC | MIH | BOLTON MEDICAL, INC. | 2311150403 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other |