RELAY PRO THORACIC STENT-GRAFT SYSTEM
Report
- Report Number
- 2247858-2023-00240
- Event Type
- Injury
- Date Received
- September 13, 2023
- Date of Event
- August 22, 2023
- Report Date
- October 11, 2023
- Manufacturer
- BOLTON MEDICAL INC.
- Product Code
- MIH
- PMA / PMN Number
- P200045
- Adverse Event
- 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.
"ENDOLEAK (TYPE IA) INTO THE FALSE LUMEN: A RELAYPRO STENT-GRAFT (28-N4-28-104-28U, LOT# 2208020273) WAS IMPLANTED ON THE DISTAL SIDE, AND THE RELAYPRO STENT-GRAFT (28-N4-34-154-30U, LOT# 2301240067) CONCERNED WAS THEN IMPLANTED ON THE PROXIMAL SIDE. DURING FINAL ANGIOGRAPHY, A TYPE IA ENDOLEAK INTO THE FALSE LUMEN OCCURRED. THE PROCEDURE WAS COMPLETED WITHOUT ADDITIONAL TREATMENT DUE TO THE PATIENT WITH A DISSECTION. INFORMATION ON THE PATIENT'S POSTOPERATIVE CONDITION WILL BE OBTAINED LATER. OPERATION TYPE: TEVAR. NO BLOOD LOSS. ANCILLARY DEVICE USED: DRYSEAL INTRODUCER SHEATH (22 FR, GORE), LUNDERQUIST EXTRA STIFF GUIDEWIRE (0.035 INCHES, 300 CM, COOK MEDICAL). MEDICATIONS USED: HEPARIN, PROTAMINE. IMAGE WILL BE AVAILABLE. PRE-CASE PLAN WILL BE AVAILABLE. ADDITIONAL INFORMATION WILL BE ABLE TO BE OBTAINED. (TC#(B)(4))."PATIENT OUTCOME - "THE PATIENT'S CONDITION IS UNKNOWN AND WILL BE UPDATED. ADDITIONAL INFORMATION OBTAINED ON SEPTEMBER 07, 2023: -THROMBOSIS HAS PROGRESSED ONE DAY AFTER THE PROCEDURE. THE PHYSICIAN EXPECTS THAT THIS TO ELIMINATE THE ENDOLEAK. CT SCAN IS SCHEDULED AGAIN IN THREE MONTHS. NO OTHER IMAGE INFORMATION CAN BE PROVIDED."
"ENDOLEAK (TYPE IA) INTO THE FALSE LUMEN: A RELAYPRO STENT-GRAFT (28-N4-28-104-28U, LOT# 2208020273) WAS IMPLANTED ON THE DISTAL SIDE, AND THE RELAYPRO STENT-GRAFT (28-N4-34-154-30U, LOT# 2301240067) CONCERNED WAS THEN IMPLANTED ON THE PROXIMAL SIDE. DURING FINAL ANGIOGRAPHY, A TYPE IA ENDOLEAK INTO THE FALSE LUMEN OCCURRED. THE PROCEDURE WAS COMPLETED WITHOUT ADDITIONAL TREATMENT DUE TO THE PATIENT WITH A DISSECTION. *INFORMATION ON THE PATIENT'S POSTOPERATIVE CONDITION WILL BE OBTAINED LATER. OPERATION TYPE: TEVAR. NO BLOOD LOSS. ANCILLARY DEVICE USED: DRYSEAL INTRODUCER SHEATH (22 FR, GORE), LUNDERQUIST EXTRA STIFF GUIDEWIRE (0.035 INCHES, 300 CM, COOK MEDICAL). MEDICATIONS USED: HEPARIN, PROTAMINE. IMAGE WILL BE AVAILABLE. PRE-CASE PLAN WILL BE AVAILABLE. ADDITIONAL INFORMATION WILL BE ABLE TO BE OBTAINED (TC#(B)(4). PATIENT OUTCOME - "THE PATIENT'S CONDITION IS UNKNOWN AND WILL BE UPDATED. ADDITIONAL INFORMATION OBTAINED ON SEPTEMBER 07, 2023: - THROMBOSIS HAS PROGRESSED ONE DAY AFTER THE PROCEDURE. THE PHYSICIAN EXPECTS THAT THIS TO ELIMINATE THE ENDOLEAK. - CT SCAN IS SCHEDULED AGAIN IN THREE MONTHS. - NO OTHER IMAGE INFORMATION CAN BE PROVIDED."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1614915 | RELAY PRO THORACIC STENT-GRAFT SYSTEM | STENT, ENDOVASCULAR GRAFT, AORTIC | MIH | BOLTON MEDICAL INC. | 2301240067 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 62 YR | Male | Other |