EVOLUT PRO PLUS VALVE
Report
- Report Number
- 2025587-2025-05180
- Event Type
- Injury
- Date Received
- July 21, 2025
- Date of Event
- July 17, 2025
- Report Date
- October 20, 2025
- Manufacturer
- MEDTRONIC MEXICO S. DE R.L. DE CV
- Product Code
- NPT
- UDI-DI
- 00763000655426
- PMA / PMN Number
- P130021
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UY
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
CONTINUATION OF D10: PRODUCT ID EVPROPLUS-26 (K029825); PRODUCT TYPE: 0195-HEART VALVES; IMPLANT DATE (B)(6) 2025 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.
IMAGE REVIEW: THIRTY-ONE IMAGES OF THE EVENT WERE PROVIDED. THERE WAS NO COMPUTED TOMOGRAPHY (CT) SCAN OR EXECUTIVE SUMMARY PROVIDED FOR REVIEW OF ANATOMICAL CONSIDERATIONS. A FLUOROSCOPIC VALVE LOAD INSPECTION WAS PROVIDED, AND EVIDENCE SHOWS IT WAS NOT A MISLOAD. IT WAS REPORTED THAT THE VALVE DISLODGED AORTIC AFTER FULL DEPLOYMENT. EVIDENCE SHOWS THE VALVE AT THE POINT OF NO RECAPTURE IN AN RIGHT ANTERIOR OBLIQUE VIEW (RAO) PROJECTION TO BE APPROXIMATELY 2MM BELOW THE BASAL PLANE. THERE IS ALSO EVIDENCE OF THE VALVE IN A LEFT ANTERIOR OBLIQUE VIEW (LAO) AT AN APPROXIMATE 4MM DEPTH ON THE LCC. THERE IS NO EVIDENCE OF THE VALVE BEING RELEASED. THE NEXT SEQUENCE SHOWS THE VALVE ABOVE THE ANNULUS BUT BELOW THE SINOTUBULAR JUNCTION (STJ). I CANNOT CONFIRM OR DENY THE CAUSE OF VALVE DISLODGEMENT. PER THE INSTRUCTIONS FOR USE (IFU) POTENTIAL RISKS ASSOCIATED WITH THE IMPLANTATION OF AN EVOLUT BIOPROSTHESIS MAY IN CLUDE BUT ARE NOT LIMITED TO CORONARY OCCLUSION COMMA OBSTRUCTION COMMA OR VESSELS SPASM, AND BIOPROSTHETIC VALVE MIGRATION. VALVE DISLODGMENT (POP-OUT) IS A SERIOUS COMPLICATION THAT OCCURS WHEN A DEPLOYED VALVE IS POSITIONED OR MIGRATES ABOVE THE AORTIC ANNULUS, RESULTING IN A VALVE POSITIONED WITHIN THE SINUS OF VALSALVA (SOV) OR ASCENDING AORTA. IN A POP-OUT TO THE SOV, THE TRANSCATHETER AORTIC VALVE (TAV) MAY MAINTAIN CONTACT WITH THE NATIVE LEAFLETS OR STJ. POP-OUTS WITHIN THE SOV REPRESENT A SERIOUS RISK FOR CORONARY OCCLUSION AND NECESSITATE AN IMMEDIATE RESPONSE IF OBSTRUCTING CORONARY PERFUSION. IT IS RECOMMENDED TO SNARE POP-OUTS AND WITHDRAW TO THE ASCENDING AORTA BELOW INNOMINATE ARTERY (MAINTAIN POSITION WITH SNARE). ENSURE PATIENT IS STABLE AND PREPARE AND DEPLOY A SECOND TAV. IT WAS REPORTED THAT THE SECOND VALVE WAS PLACED WITHOUT SNARING OR REPOSITIONING THE DISLODGED VALVE. IT WAS REPORTED THAT AFTER THE SECOND VALVE WAS IMPLANTED, BLOOD PRESSURE WAS NOT DETECTED AND THE PATIENT EXPERIENCED RAPID PROGRESSION TO CARDIORESPIRATORY ARREST. EXTERNAL CARDIAC MASSAGE, OROTRACHEAL INTUBATION, MECHANICAL VENTILATION, INTRAVENOUS ADRENALINE, AND CORRECTION OF METABOLIC ACIDOSIS WITH MOLAR BICARBONATED SERUM WERE PERFORMED. CORONARY OCCLUSION WAS DOCUMENTED BY AORTOGRAM. THERE IS EVIDENCE OF A POST-IMPLANT BALLOON AORTIC VALVULOPLASTY (BAV) DONE AFTER PLACEMENT OF THE SECOND VALVE. IT WAS REPORTED WITHOUT EVIDENCE THAT; CORONARY OCCLUSION WAS DOCUMENTED BY AORTOGRAM, PROMPTING TRACTION OF THE IMPLANTED PROSTHESES WITH A TRIFOLIAR LOOP TO FREE THE CORONARY OSTIA, DISPLACING THE PROSTHESES DISTALLY INTO THE TUBULAR PORTION OF THE ASCENDING AORTA. CONTROL AORTOGRAPHY THEN SHOWED MODERATE TO SEVERE AORTIC INSUFFICIENCY WITH NORMAL CORONARY FLOW. EVIDENCE DOES SHOW BOTH THE FIRST AND SECOND VALVE ABOVE THE ANNULUS. A THIRD VALVE WAS THEN PLACED AND THERE IS EVIDENCE THAT SHOWS CORONARY PERFUSION. UPDATED DATA: 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 H.6 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 INFORMATION: B5 (SECOND PARAGRAPH), D3, AND 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. A THIRD PARAGRAPH WAS ADDED. H6. ADDITIONAL CODES. 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.
IT WAS REPORTED THAT DURING A TRANSCATHETER AORTIC VALVE IMPLANTATION PROCEDURE THROUGH THE RIGHT FEMORAL ACCESS, A DISTAL DISPLACEMENT OF THE PROSTHESIS ABOVE THE PLANE OF THE AORTIC VALVE ANNULUS WAS OBSERVED AFTER RELEASE. FOLLOWING THIS, A SECOND VALVE WAS IMPLANTED VALVE-IN-VALVE. CONTROL AORTOGRAPHY SHOWED NORMAL CORONARY FLOW AT THAT TIME. AFTER THE SECOND VALVE WAS IMPLANTED, BLOOD PRESSURE WAS NOT DETECTED AND THE PATIENT EXPERIENCED RAPID PROGRESSION TO CARDIORESPIRATORY ARREST. EXTERNAL CARDIAC MASSAGE, OROTRACHEAL INTUBATION, MECHANICAL VENTILATION, INTRAVENOUS ADRENALINE, AND CORRECTION OF METABOLIC ACIDOSIS WITH MOLAR BICARBONATED SERUM WERE PERFORMED. CORONARY OCCLUSION WAS DOCUMENTED BY AORTOGRAM, PROMPTING TRACTION OF THE IMPLANTED PROSTHESES WITH A TRIFOLIAR LOOP TO FREE THE CORONARY OSTIA, DISPLACING THE PROSTHESES DISTALLY INTO THE TUBULAR PORTION OF THE ASCENDING AORTA. CONTROL AORTOGRAPHYTHEN SHOWED MODERATE TO SEVERE AORTIC INSUFFICIENCY WITH NORMAL CORONARY FLOW. A THIRD VALVE, WAS SUBSEQUENTLY IMPLANTED SUCCESSFULLY.
IT WAS REPORTED THAT DURING A TRANSCATHETER AORTIC VALVE IMPLANTATION PROCEDURE THROUGH THE RIGHT FEMORAL ACCESS, A DISTAL DISPLACEMENT OF THE PROSTHESIS ABOVE THE PLANE OF THE AORTIC VALVE ANNULUS WAS OBSERVED AFTER RELEASE. FOLLOWING THIS, A SECOND VALVE WAS IMPLANTED VALVE-IN-VALVE. CONTROL AORTOGRAPHY SHOWED NORMAL CORONARY FLOW AT THAT TIME. AFTER THE SECOND VALVE WAS IMPLANTED, BLOOD PRESSURE WAS NOT DETECTED AND THE PATIENT EXPERIENCED RAPID PROGRESSION TO CARDIORESPIRATORY ARREST. EXTERNAL CARDIAC MASSAGE, OROTRACHEAL INTUBATION, MECHANICAL VENTILATION, INTRAVENOUS ADRENALINE, AND CORRECTION OF METABOLIC ACIDOSIS WITH MOLAR BICARBONATED SERUM WERE PERFORMED. CORONARY OCCLUSION WAS DOCUMENTED BY AORTOGRAM, PROMPTING TRACTION OF THE IMPLANTED PROSTHESES WITH A TRIFOLIAR LOOP TO FREE THE CORONARY OSTIA, DISPLACING THE PROSTHESES DISTALLY INTO THE TUBULAR PORTION OF THE ASCENDING AORTA. CONTROL AORTOGRAPHY THEN SHOWED MODERATE TO SEVERE AORTIC INSUFFICIENCY WITH NORMAL CORONARY FLOW. A THIRD VALVE, WAS SUBSEQUENTLY IMPLANTED SUCCESSFULLY. ADDITIONAL INFORMATION WAS RECEIVED FROM THE PHYSICIAN INDICATING THAT THE CORONARY OCCLUSION WAS CAUSED BY THE POST-DILATION THAT WAS PERFORMED WITH A NON-MEDTRONIC BALLOON AFTER THE SECOND VALVE WAS IMPLANTED. ADDITIONALLY, IT WAS CLARIFIED THAT SEVERE AORTIC INSUFFICIENCY WAS NOTED FOLLOWING THE DISLODGEMENT OF THE FIRST VALVE AND WAS ALSO NOTED AFTER THE SECOND VALVE WAS REPOSITIONED. MILD AORTIC INSUFFICIENCY WAS OBSERVED AFTER THE THIRD VALVE WAS IMPLANTED.
IT WAS REPORTED THAT DURING A TRANSCATHETER AORTIC VALVE IMPLANTATION PROCEDURE THROUGH THE RIGHT FEMORAL ACCESS, A DISTAL DISPLACEMENT OF THE PROSTHESIS ABOVE THE PLANE OF THE AORTIC VALVE ANNULUS WAS OBSERVED AFTER RELEASE. FOLLOWING THIS, A SECOND VALVE WAS IMPLANTED VALVE-IN-VALVE. CONTROL AORTOGRAPHY SHOWED NORMAL CORONARY FLOW AT THAT TIME. AFTER THE SECOND VALVE WAS IMPLANTED, BLOOD PRESSURE WAS NOT DETECTED AND THE PATIENT EXPERIENCED RAPID PROGRESSION TO CARDIORESPIRATORY ARREST. EXTERNAL CARDIAC MASSAGE, OROTRACHEAL INTUBATION, MECHANICAL VENTILATION, INTRAVENOUS ADRENALINE, AND CORRECTION OF METABOLIC ACIDOSIS WITH MOLAR BICARBONATED SERUM WERE PERFORMED. CORONARY OCCLUSION WAS DOCUMENTED BY AORTOGRAM, PROMPTING TRACTION OF THE IMPLANTED PROSTHESES WITH A TRIFOLIAR LOOP TO FREE THE CORONARY OSTIA, DISPLACING THE PROSTHESES DISTALLY INTO THE TUBULAR PORTION OF THE ASCENDING AORTA. CONTROL AORTOGRAPHYTHEN SHOWED MODERATE TO SEVERE AORTIC INSUFFICIENCY WITH NORMAL CORONARY FLOW. A THIRD VALVE, WAS SUBSEQUENTLY IMPLANTED SUCCESSFULLY. ADDITIONAL INFORMATION WAS RECEIVED FROM THE PHYSICIAN INDICATING THAT THE CORONARY OCCLUSION WAS CAUSED BY THE POST-IMPLANT DILATION THAT WAS PERFORMED WITH A NON-MEDTRONIC BALLOON AFTER THE SECOND VALVE WAS IMPLANTED. ADDITIONALLY, IT WAS CLARIFIED THAT SEVERE AORTIC INSUFFICIENCY WAS NOTED FOLLOWING THE DISLODGEMENT OF THE FIRST VALVE AND WAS ALSO NOTED AFTER THE SECOND VALVE WAS REPOSITIONED. MILD AORTIC INSUFFICIENCY WAS OBSERVED AFTER THE THIRD VALVE WAS IMPLANTED. ADDITIONAL INFORMATION WAS RECEIVED TO CLARIFY AFTER FIRST VALVE DISLODGED, SEVERE CENTRAL AORTIC INSUFFICIENCY WAS NOTED. AFTER THE SECOND VALVE WAS IMPLANTED, MILD-MODERATE PARAVALVULAR LEAK (PVL) WAS NOTED. AFTER THE THIRD VALVE WAS IMPLANTED, THE PVL WAS REDUCED TO MILD.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1937386 | EVOLUT PRO PLUS VALVE | AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV | NPT | MEDTRONIC MEXICO S. DE R.L. DE CV | EVPROPLUS-26 | 00763000655426 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 89 YR | Female | Required Intervention| L |