RELAY PLUS THORACIC STENT-GRAFT SYSTEM
Report
- Report Number
- 2247858-2024-00248
- Event Type
- Malfunction
- Date Received
- September 27, 2024
- Date of Event
- August 30, 2024
- Report Date
- February 21, 2025
- Manufacturer
- BOLTON MEDICAL, INC.
- Product Code
- MIH
- UDI-DI
- 08435761002192
- PMA / PMN Number
- P110038
- 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 ADVANCE THE INNER SHEATH: THE DELIVERY SYSTEM WAS ADVANCED INTO THE ARTERY AND THEN THE INNER SHEATH WAS ATTEMPTED TO BE ADVANCED OUT OF THE OUTER SHEATH. HOWEVER, THE INNER SHEATH WAS UNABLE TO PASS THROUGH THE UPPER PART OF THE CURVATURE OF THE AORTIC ARCH. PUSH-PULL MANIPULATION AND ROTATIONAL TORQUE WERE APPLIED, BUT THE INNER SHEATH WAS UNABLE TO BE PASSED THROUGH. THE PHYSICIAN CONSIDERED PERFORMING A PULL-THROUGH TECHNIQUE WITH THE DELIVERY SYSTEM KEPT IN THE AORTA, BUT DECIDED NOT TO PROCEED FURTHER AS IT WAS OBSERVED THAT THE INNER SHEATH HAD ALREADY BEEN PULLED DOWN SLIGHTLY, ALTHOUGH THE PROXIMAL STENT HAD NOT YET BEEN RELEASED. THE DELIVERY SYSTEM WAS ABLE TO BE SUCCESSFULLY REMOVED FROM THE PATIENT WITH THE AID OF THE LARGE ACCESS VESSEL, ALTHOUGH THE INNER SHEATH HAD ALREADY BEEN ADVANCED OUT OF THE OUTER SHEATH. OBSERVATION OF THE REMOVED DELIVERY SYSTEM REVEALED THAT THE INNER SHEATH HAD BEEN PULLED DOWN SLIGHTLY AND THE BARE STENT WAS EXPOSED, AS SPECULATED. AS THE DESCENDING AORTA WAS SIGNIFICANTLY TORTUOUS IN AN S-SHAPE AND THE UPPER PART OF THE CURVED AORTIC ARCH WAS QUITE NARROW, A PULL-THROUGH TECHNIQUE WAS PERFORMED TO ALLOW THE DELIVERY SYSTEM OF THE RELAY PRO NBS (28-M4-34-145-30U) TO PASS THROUGH THE AORTA AND REACH THE TARGET POSITION. THE RELAY PRO NBS WAS SUCCESSFULLY PLACED. SUBSEQUENTLY, THE PROCEDURE WAS COMPLETED SUCCESSFULLY. OPERATION TYPE: TEVAR. BLOOD LOSS: AMOUNT IS UNKNOWN. NO IMAGE AVAILABLE DUE TO HOSPITAL POLICY. PRE-CASE PLAN AVAILABLE. NO ADDITIONAL INFORMATION AVAILABLE DUE TO HOSPITAL POLICY. DELIVERY SYSTEM WAS DISCARDED BY USER: ANCILLARY DEVICES USED: STIFF GUIDEWIRE: LUNDERQUIST EXTRA-STIFF WIRE GUIDE, COOK MEDICAL. (TC#: (B)(4). PATIENT OUTCOME: "NO HARM TO THE PATIENT'S HEALTH."
"UNABLE TO ADVANCE THE INNER SHEATH: THE DELIVERY SYSTEM WAS ADVANCED INTO THE ARTERY AND THEN THE INNER SHEATH WAS ATTEMPTED TO BE ADVANCED OUT OF THE OUTER SHEATH. HOWEVER, THE INNER SHEATH WAS UNABLE TO PASS THROUGH THE UPPER PART OF THE CURVATURE OF THE AORTIC ARCH. PUSH-PULL MANIPULATION AND ROTATIONAL TORQUE WERE APPLIED, BUT THE INNER SHEATH WAS UNABLE TO BE PASSED THROUGH. THE PHYSICIAN CONSIDERED PERFORMING A PULL-THROUGH TECHNIQUE WITH THE DELIVERY SYSTEM KEPT IN THE AORTA, BUT DECIDED NOT TO PROCEED FURTHER AS IT WAS OBSERVED THAT THE INNER SHEATH HAD ALREADY BEEN PULLED DOWN SLIGHTLY, ALTHOUGH THE PROXIMAL STENT HAD NOT YET BEEN RELEASED. THE DELIVERY SYSTEM WAS ABLE TO BE SUCCESSFULLY REMOVED FROM THE PATIENT WITH THE AID OF THE LARGE ACCESS VESSEL, ALTHOUGH THE INNER SHEATH HAD ALREADY BEEN ADVANCED OUT OF THE OUTER SHEATH. OBSERVATION OF THE REMOVED DELIVERY SYSTEM REVEALED THAT THE INNER SHEATH HAD BEEN PULLED DOWN SLIGHTLY AND THE BARE STENT WAS EXPOSED, AS SPECULATED. AS THE DESCENDING AORTA WAS SIGNIFICANTLY TORTUOUS IN AN S-SHAPE AND THE UPPER PART OF THE CURVED AORTIC ARCH WAS QUITE NARROW, A PULL-THROUGH TECHNIQUE WAS PERFORMED TO ALLOW THE DELIVERY SYSTEM OF THE RELAY PRO NBS (28-M4-34-145-30U) TO PASS THROUGH THE AORTA AND REACH THE TARGET POSITION. THE RELAY PRO NBS WAS SUCCESSFULLY PLACED. SUBSEQUENTLY, THE PROCEDURE WAS COMPLETED SUCCESSFULLY. OPERATION TYPE: TEVAR BLOOD LOSS: AMOUNT IS UNKNOWN. NO IMAGE AVAILABLE DUE TO HOSPITAL POLICY PRE-CASE PLAN AVAILABLE NO ADDITIONAL INFORMATION AVAILABLE DUE TO HOSPITAL POLICY DELIVERY SYSTEM WAS DISCARDED BY USER ANCILLARY DEVICES USED: STIFF GUIDEWIRE: LUNDERQUIST EXTRA-STIFF WIRE GUIDE, COOK MEDICAL (TC# (B)(4)" PATIENT OUTCOME: "NO HARM TO THE PATIENT'S HEALTH."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1433216 | RELAY PLUS THORACIC STENT-GRAFT SYSTEM | STENT, ENDOVASCULAR GRAFT, AORTIC | MIH | BOLTON MEDICAL, INC. | 2107090030 | 08435761002192 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other |