EVOLUT FX DCS
Report
- Report Number
- 2025587-2024-04581
- Event Type
- Death
- Date Received
- August 14, 2024
- Date of Event
- August 8, 2024
- Report Date
- June 6, 2025
- Manufacturer
- MEDTRONIC HEART VALVES DIVISION
- Product Code
- NPT
- PMA / PMN Number
- P130021
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
CONTINUATION OF D10: PRODUCT ID EVOLUTFX-34 SERIAL: (B)(6); PRODUCT TYPE: 0195-HEART VALVES. 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. 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: B2. B5. H1. H6. H11. CONTINUATION OF D10: PRODUCT ID EVOLUTFX-34 (LOT: J223731); PRODUCT TYPE: 0195-HEART VALVES; IMPLANT DATE (B)(6) 2024; EXPLANT DATE N/A. 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.
THIS IS A SYSTEM REPORT. THE SECTION D INFORMATION IS FOR THE PRIMARY DEVICE, WHICH WAS IN USE WITH THE FOLLOWING: BRAND NAME EVOLUTFX VALVE; PRODUCT ID EVOLUTFX-34; SERIAL (B)(6); USE BY DATE 2026-06-05; UDI (B)(4). UPDATED: B5, H6, H11. 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.
CONTINUATION OF D10: PRODUCT ID EVOLUTFX-34 (LOT: UNKNOWN); PRODUCT TYPE: 0195-HEART VALVES; SELECT PATIENT INFORMATION CANNOT BE INCLUDED IN THE REGULATORY REPORT DUE TO REGIONAL PRIVACY REGULATIONS. 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 RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, A VASCULAR INJURY AT THE ACCESS SITE WAS NOTED. SUBSEQUENTLY, A STENT WAS PLACED TO TREAT THE VASCULAR INJURY. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED THAT THE VASCULAR ACCESS SITE WAS INITIALLY THE RIGHT FEMORAL ARTERY BUT WAS SWITCHED TO THE LEFT FEMORAL ARTERY. THE INJURY WAS NOTED ON THE LEFT COMMON ILIAC ARTERY TO THE EXTERNAL ILIAC ARTERY. PER THE PHYSICIAN, THE DELIVERY CATHETER SYSTEM AND THE SHEATH CONTRIBUTED TO THE INJURY, ALONG WITH "VASCULAR RUNNING" AND CALCIFICATION.
ADDITIONAL INFORMATION WAS RECEIVED THAT CLARIFIED PREVIOUSLY REPORTED INFORMATION INDICATING THAT "VASCULAR RUNNING" MEANT THAT THERE WAS FLEXION AT THE BRANCH FROM THE ABDOMINAL AORTA TO THE ROOT. ADDITIONALLY, A 22 FRENCH AND 18 FRENCH NON-MEDTRONIC SHEATH WERE USED DURING THE PROCEDURE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
ADDITIONAL INFORMATION WAS RECEIVED THAT THE NIGHT OF THE IMPLANT OF THE VALVE, THE PATIENT'S CONDITION WORSENED. SUBSEQUENTLY, THE NEXT DAY, THE PATIENT EXPERIENCED CARDIAC ARREST AND EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) WAS URGENTLY INTRODUCED. A CLOSE EXAMINATION OF THE CAUSE REVEALED A PERIPHERAL BLOOD VESSEL THROMBOEMBOLISM AND THROMBUS OCCLUSION IN THE EXTERNAL ILIAC ARTERY ON THE CONTRALATERAL SIDE OF THE STENT THAT WAS PREVIOUSLY PLACED. PER THE PHYSICIAN, THE PATIENT DEVELOPED CARDIAC ARREST DUE TO ISCHEMIA IN THE LOWER LIMBS CAUSED BY AN ACUTE LOWER LIMB ARTERIAL EMBOLISM. THE PATIENT'S CONDITION DID NOT IMPROVE AND THE PATIENT SUBSEQUENTLY DIED. PER THE PHYSICIAN, THE DEATH WAS RELATED TO THE VALVE IMPLANT PROCEDURE. THE CAUSE OF DEATH WAS REPORTED AS CARDIOVASCULAR.
MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, A VASCULAR INJURY AT THE ACCESS SITE WAS NOTED. SUBSEQUENTLY, A STENT WAS PLACED TO TREAT THE VASCULAR INJURY. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED THAT THE VASCULAR ACCESS SITE WAS INITIALLY THE RIGHT FEMORAL ARTERY BUT WAS SWITCHED TO THE LEFT FEMORAL ARTERY. THE INJURY WAS NOTED ON THE LEFT COMMON ILIAC ARTERY TO THE EXTERNAL ILIAC ARTERY. PER THE PHYSICIAN, THE DELIVERY CATHETER SYSTEM (DCS) AND THE SHEATH CONTRIBUTED TO THE INJURY, ALONG WITH "VASCULAR RUNNING" AND CALCIFICATION. ADDITIONAL INFORMATION WAS RECEIVED THAT CLARIFIED PREVIOUSLY REPORTED INFORMATION INDICATING THAT "VASCULAR RUNNING" MEANT THAT THERE WAS FLEXION AT THE BRANCH FROM THE ABDOMINAL AORTA TO THE ROOT. ADDITIONALLY, A 22 FRENCH AND 18 FRENCH NON-MEDTRONIC (GORE-DRY SEAL) SHEATH WERE USED DURING THE PROCEDURE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED THAT THE NIGHT OF THE IMPLANT OF THE VALVE, THE PATIENT'S CONDITION WORSENED. SUBSEQUENTLY, THE NEXT DAY, THE PATIENT EXPERIENCED CARDIAC ARREST AND EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) WAS URGENTLY INTRODUCED. A CLOSE EXAMINATION OF THE CAUSE REVEALED A PERIPHERAL BLOOD VESSEL THROMBOEMBOLISM AND THROMBUS OCCLUSION IN THE EXTERNAL ILIAC ARTERY ON THE CONTRALATERAL SIDE OF THE STENT THAT WAS PREVIOUSLY PLACED. PER THE PHYSICIAN, THE PATIENT DEVELOPED CARDIAC ARREST DUE TO ISCHEMIA IN THE LOWER LIMBS CAUSED BY AN ACUTE LOWER LIMB ARTERIAL EMBOLISM. THE PATIENT'S CONDITION DID NOT IMPROVE AND THE PATIENT SUBSEQUENTLY DIED. PER THE PHYSICIAN, THE DEATH WAS RELATED TO THE VALVE IMPLANT PROCEDURE. THE CAUSE OF DEATH WAS REPORTED AS CARDIOVASCULAR. ADDITIONAL INFORMATION WAS RECEIVED THAT THE VALVE WAS IMPLANTED INTO THE NATIVE ANNULUS WITH A FINAL IMPLANT DEPTH OF 3 MM ON THE N ON-CORONARY CUSP (NCC) AND LEFT CORONARY CUSP (LCC). PER THE PHYSICIAN, THE CAUSE OF THE PERIPHERAL THROMBOEMBOLISM/OCCLUSION WAS THE DCS BUT IT WAS UNKNOWN WHETHER THE VALVE CONTRIBUTED.
MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, A VASCULAR INJURY AT THE ACCESS SITE WAS NOTED. SUBSEQUENTLY, A STENT WAS PLACED TO TREAT THE VASCULAR INJURY. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 535074 | EVOLUT FX DCS | AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV | NPT | MEDTRONIC HEART VALVES DIVISION | D-EVOLUTFX-34 | 0012174632 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention| D | SEE H11.| SEE H11. |