EVOLUT PRO TRANSCATHETER AORTIC VALVE
Report
- Report Number
- 2025587-2024-03130
- 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
- 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: 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.
B2: DATE OF DEATH IS UNKNOWN. CONTINUATION OF D10: PRODUCT ID ENVPRO-16 (LOT: 0011651364), PRODUCT TYPE: 0195-HEART VALVES; PRODUCT ID: GWBC30, (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-26, (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.
CORRECTED DATA: IMAGE REVIEW: CORRECTED TO INCLUDE THE FOLLOWING: PATIENT¿S EXECUTIVE SUMMARY WAS PROVIDED FOR ANATOMICAL REVIEW. PATIENT¿S ANNULUS PERIMETER MEASURED 72 MILLIMETER (MM) WITH A PERIMETER DERIVED DIAMETER OF 22.9MM SUGGESTING A 26MM EVOLUT. EVEN THOUGH THE SINUSES OF VALSALVA COULD ACCOMMODATE A 29MM EVOLUT, THE PERIMETER MEASUREMENTS SUGGESTED A 26MM, PER THE INSTRUCTIONS FOR USE (IFU). UPDATED DATA: H6 CONCLUSION: THE DEVICE HISTORY RECORD WAS REVIEWED AND SHOWED THIS PRODUCT MET ALL MANUFACTURING SPECIFICATIONS FOR PRODUCT RELEASED FOR DISTRIBUTION. NO ISSUES WERE IDENTIFIED THAT WOULD HAVE IMPACTED THIS EVENT. THE REPORT OF PATIENT DEATH UNSPECIFIED AMOUNT OF TIME POST IMPLANT DID NOT PROVIDE SPECIFIC CAUSE. IT IS UNKNOWN IF AN AUTOPSY WAS NOT PERFORMED. WITH THE LIMITED INFORMATION AVAILABLE, A RELATIONSHIP BETWEEN THE DEVICE AND THE DEATH COULD NOT BE ESTABLISHED. THERE IS NO INFORMATION TO SUGGEST A DEVICE QUALITY DEFICIENCY THAT MAY HAVE CAUSED OR CONTRIBUTED TO THIS EVENT. 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 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.
UPDATED DATA: B5 - SECOND PARAGRAPH 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. 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 (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. ADDITIONAL INFORMATION WAS RECEIVED THAT FOLLOWING THE VALVE (B)(6) 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 |
|---|---|---|---|---|---|---|---|
| 651743 | EVOLUT PRO TRANSCATHETER AORTIC VALVE | AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV | NPT | MEDTRONIC HEART VALVES DIVISION | EVOLUTPRO-29 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 84 YR | Female | Required Intervention| D |