CUSTOM-MADE RELAY PLUS NBS (TRIPLE BRANCH) THORACIC STENT-GRAFT
Report
- Report Number
- 2247858-2024-00105
- Event Type
- Death
- Date Received
- May 7, 2024
- Date of Event
- April 11, 2024
- Report Date
- October 10, 2024
- Manufacturer
- BOLTON MEDICAL, INC.
- Product Code
- MIH
- PMA / PMN Number
- P110038
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- 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 IS VOLUNTARILY REPORTING AN EVENT RELATED TO A RELAY PLUS CUSTOM-MADE DEVICE. THE CUSTOM MADE RELAY PLUS DEVICES ARE NOT MARKETED IN THE US, HOWEVER THEY ARE SIMILAR TO THE RELAY THORACIC STENT GRAFT WITH PLUS DELIVERY SYSTEM APPROVED FOR SALE IN THE US (P110038). THE EVENT OCCURRED IN GERMANY.
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 IS VOLUNTARILY REPORTING AN EVENT RELATED TO A RELAY PLUS CUSTOM-MADE DEVICE. THE CUSTOM MADE RELAY PLUS DEVICES ARE NOT MARKETED IN THE US, HOWEVER THEY ARE SIMILAR TO THE RELAY THORACIC STENT GRAFT WITH PLUS DELIVERY SYSTEM APPROVED FOR SALE IN THE US (P110038). THE EVENT OCCURRED IN GERMANY.
"PHYSICIAN ADVANCED THE DEVICE THROUGH THE EXTERNAL ILIACS. DURING ADVANCEMENT THERE WAS ALREADY A MISMATCH BETWEEN THE D MARKER AND THE WINDOW MARKER RECOGNIZED. THE D MARKER WAS ON THE OPPOSITE SITE OF THE PROX AND DIST WINDOW MARKER OF THE FENESTRATION. IN THE DESCENDING THE PHYSICIAN ALIGNED (70° LAO) THE WINDOW MARKER ON THE OUTER CURVE. D MARKER STILL MISMATCHED. THEN THE PHYSICIAN ADVANCED THE INNERSHEATH INTO THE ARCH RECOGNIZING A TWIST OF THE STENT-GRAFT DURING ADVANCEMENT WITH DOWNWARDS FACING WINDOW UND UPWARDS FACING D-MARKER. DURING THE MANIPULATION TO REDUCE THE TWIST THE PATIENT STARTED TO GET UNSTABLE AND IT WAS NESSESSARY TO REANIMATE. PHYSICAN DO NOT WANT TO DEPLOY IN THE ASCENDING AND DEPLOYED THE STENT-GRAFT IN THE DESCENDING. PATIENT REMAINED UNSTABLE. PHYSICIANS WERE NOT ABLE STOP THE INTERNAL BLEEDING." PATIENT OUTCOME: "ANEURYSM RUPTURED DURING IMPLANTATION. PATIENT DIED."
"PHYSICIAN ADVANCED THE DEVICE THROUGH THE EXTERNAL ILIACS. DURING ADVANCEMENT THERE WAS ALREADY A MISMATCH BETWEEN THE D MARKER AND THE WINDOW MARKER RECOGNIZED. THE D MARKER WAS ON THE OPPOSITE SITE OF THE PROX AND DIST WINDOW MARKER OF THE FENESTRATION. IN THE DESCENDING THE PHYSICIAN ALIGNED (70° LAO) THE WINDOW MARKER ON THE OUTER CURVE. D MARKER STILL MISMATCHED. THEN THE PHYSICIAN ADVANCED THE INNERSHEATH INTO THE ARCH RECOGNIZING A TWIST OF THE STENT-GRAFT DURING ADVANCEMENT WITH DOWNWARDS FACING WINDOW AND UPWARDS FACING D-MARKER. DURING THE MANIPULATION TO REDUCE THE TWIST THE PATIENT STARTED TO GET UNSTABLE AND IT WAS NECESSARY TO REANIMATE. PHYSICIAN DO NOT WANT TO DEPLOY IN THE ASCENDING AND DEPLOYED THE STENT-GRAFT IN THE DESCENDING. PATIENT REMAINED UNSTABLE. PHYSICIANS WERE NOT ABLE STOP THE INTERNAL BLEEDING." PATIENT OUTCOME:"ANEURYSM RUPTURED DURING IMPLANTATION. PATIENT DIED."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 641854 | CUSTOM-MADE RELAY PLUS NBS (TRIPLE BRANCH) THORACIC STENT-GRAFT | STENT, ENDOVASCULAR GRAFT, AORTIC | MIH | BOLTON MEDICAL, INC. | 2312130457 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Female | Death| R |