EVOLUT PRO TRANSCATHETER AORTIC VALVE
Report
- Report Number
- 2025587-2024-03131
- Event Type
- Death
- Date Received
- May 28, 2024
- Date of Event
- December 21, 2023
- Report Date
- August 13, 2024
- Manufacturer
- MEDTRONIC HEART VALVES DIVISION
- Product Code
- NPT
- PMA / PMN Number
- P130021
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BR
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
IMAGE REVIEW: INTRA PROCEDURAL FLUOROSCOPIC IMAGES WERE PROVIDED FOR REVIEW OF THE EVENT. THE PATIENT¿S EXECUTIVE SUMMARY WAS NOT PROVIDED FOR ANATOMICAL REVIEW. FLUOROSCOPIC VALVE LOAD INSPECTION WAS PROVIDED FOR REVIEW AND CONFIRMED A GOOD LOAD. JUST PRIOR TO THE POINT OF NO RECAPTURE, DEPTH ASSESSMENT WAS PERFORMED AND APPEARED TO BE APPROXIMATELY 1MM ON THE NON-CORONARY CUSP (NCC) AND 0MM ON LEFT-CORONARY CUSP (LCC). OF NOTE, MEDTRONIC RECOMMENDS A TARGET DEPTH OF 3MM. RECAPTURE IS RECOMMENDED IF DEPTH <(><<)>1MM OR >5MM. AS LISTED IN THE INSTRUCTIONS FOR USE (IFU), BIOPROSTHESIS IMPLANT DEPTH <(><<)>1 MM MAY CONTRIBUTE TO AN INCREASED RISK OF PROSTHETIC VALVE DISLODGEMENT DURING VALVE RELEASE, DELIVERY CATHETER SYSTEM (DCS) RETRIEVAL, OR POST-IMPLANT DILATATION. DESPITE THE SHALLOW DEPTH, THE VALVE WAS RELEASED BUT APPEARED STABLE IMMEDIATELY POST RELEASE. DURING THE POST IMPLANT DILATATION, THE EVOLUT APPEARED TO HAVE DISLODGED TO THE LEVEL OF THE SINUSES OF VALSALVA (SOV) MID BALLOON INFLATION. A SECOND VALVE WAS PREPPED, AND FLUOROSCOPIC VALVE LOAD INSPECTION CONFIRMED A GOOD LOAD. IT WAS REPORTED THAT A DECISION WAS MADE TO IMPLANT A LARGER VALVE SIZE AS A SECOND VALVE. THE PATIENT¿S ANATOMY IS UNKNOWN THUS IT IS NOT POSSIBLE TO VALIDATE IF THE ANATOMY WAS LARGE ENOUGH TO ACCOMMODATE A LARGER VALVE SIZE. THE DISLODGED VALVE WAS NOT SNARED AND WAS LEFT AT THE SOV AND A SECOND VALVE WAS IMPLANTED. THE FINAL ANGIOGRAM SHOWS EVIDENCE OF CORONARY FLOW. IT WAS REPORTED THAT THE PATIENT LATER DIED. CAUSE OF DEATH REMAINS UNDETERMINED. OF NOTE, AS STATED IN THE IFU, POTENTIAL RISKS ASSOCIATED WITH THE IMPLANTATION OF THE EVOLUT PRO BIOPROSTHESIS MAY INCLUDE BUT ARE NOT LIMITED TO DEATH. UPDATED: B1, B5, H6 MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.
B3: DATE OF DEATH IS UNKNOWN. CONTINUATION OF D10: PRODUCT ID ENVPRO-16 (LOT: 0011651364); PRODUCT TYPE: 0195-HEART VALVES PRODUCT ID (B)(6) (LOT: 92106966); PRODUCT TYPE: 0193-GUIDEWIRE PRODUCT ID L-ENVPRO-16 (LOT: 0011587500); PRODUCT TYPE: 0195-HEART VALVES PRODUCT ID ENVPRO-16 (LOT: 0011454396); PRODUCT TYPE: 0195-HEART VALVES PRODUCT ID EVOLUTPRO-29 (B)(6); PRODUCT TYPE: 0195-HEART VALVES; IMPLANT DATE (B)(6) 2023. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.
UPDATED H11 WITH ADDITIONAL INFORMATION RECEIVED FOR IMAGE REVIEW. IMAGE REVIEW: THE PATIENT¿S EXECUTIVE SUMMARY WAS PROVIDED FOR ANATOMICAL REVIEW. THE PATIENT¿S ANNULUS PERIMETER MEASURED 72 MM WITH A PERIMETER DERIVED DIAMETER OF 22.9 MM SUGGESTING A 26 MM VALVE. EVEN THOUGH THE SINUSES OF VALSALVA COULD ACCOMMODATE A 29 MM VALVE, THE PERIMETER MEASUREMENTS SUGGESTED A 26 MM, PER THE INSTRUCTIONS FOR USE (IFU). CORRECTED H1 TO REMOVE DEATH WHICH WAS INADVERTENTLY SELECTED IN THE SUPPLEMENTAL MEDWATCH SUBMITTED JULY 12, 2024 AS THIS IS A SERIOUS INJURY REPORT. INFORMATION PERTAINING TO THE DEATH WAS REPORTED IN MEDWATCH# 2025587-2024-03130. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.
MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.
MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.
ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THE PARAVALVULAR LEAK (PVL) WAS MODERATE.
MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, THE VALVE (B)(6) WAS SUCCESSFULLY IMPLANTED. DURING POST-DILATION, THE PATIENT EXPERIENCED EXTRASYSTOLE AND THE VALVE BECAME DISLODGED. AS THE PATIENT WAS BORDERLINE, THE PHYSICIAN HAD DECIDED TO IMPLANT THE SMALLER 26MM VALVE FIRST. AFTER THE DISLODGE OF THE FIRST VALVE, THE PHYSICIAN CHOSE TO IMPLANT A LARGER 29MM VALVE (B)(6). ON THE DAY OF THE PROCEDURE, THE PATIENT PROGRESSED WELL AND THERE WERE NO HEMODYNAMIC REPERCUSSIONS. AN UNSPECIFIED AMOUNT OF TIME AFTER THE PROCEDURE, THE PATIENT SUDDENLY DIED AT HOME OF UNKNOWN CAUSES.
MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, THE VALVE (F533643) WAS SUCCESSFULLY IMPLANTED. DURING POST-DILATION, THE PATIENT EXPERIENCED EXTRASYSTOLE AND THE VALVE BECAME DISLODGED. AS THE PATIENT WAS BORDERLINE, THE PHYSICIAN HAD DECIDED TO IMPLANT THE SMALLER 26MM VALVE FIRST. AFTER THE DISLODGE OF THE FIRST VALVE, THE PHYSICIAN CHOSE TO IMPLANT A LARGER 29MM VALVE (J012985). ON THE DAY OF THE PROCEDURE, THE PATIENT PROGRESSED WELL AND THERE WERE NO HEMODYNAMIC REPERCUSSIONS. AN UNSPECIFIED AMOUNT OF TIME AFTER THE PROCEDURE, THE PATIENT SUDDENLY DIED AT HOME OF UNKNOWN CAUSES. ADDITIONAL INFORMATION WAS RECEIVED THAT FOLLOWING THE VALVE (F533643) IMPLANT, THE PATIENT WAS RAPID PACED DURING THE BALLOON DILATATION FOR PARAVALVULAR LEAK (PVL).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 677699 | EVOLUT PRO TRANSCATHETER AORTIC VALVE | AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV | NPT | MEDTRONIC HEART VALVES DIVISION | EVOLUTPRO-26 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 84 YR | Female | Required Intervention | SEE H11... |