EVOLUT R TRANSCATHETER AORTIC VALVE
Report
- Report Number
- 2025587-2023-03553
- Event Type
- Death
- Date Received
- August 29, 2023
- Date of Event
- August 3, 2023
- Report Date
- January 7, 2026
- Manufacturer
- MEDTRONIC HEART VALVES DIVISION
- Product Code
- NPT
- PMA / PMN Number
- P130021
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
PRODUCT ANALYSIS: THE DEVICE REMAINS IMPLANTED AND NO PROCEDURAL IMAGES WERE SUBMITTED FOR REVIEW; THEREFORE, NO PRODUCT ANALYSIS CAN BE PERFORMED. CONCLUSION: WITHOUT THE RETURN OF THE PRODUCT, NO DEFINITIVE CONCLUSION CAN BE MADE REGARDING THE CLINICAL OBSERVATION. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED 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. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED 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. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED 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. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT.
MEDTRONIC RECEIVED INFORMATION THAT APPROXIMATELY EIGHT YEARS FOLLOWING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, THE PATIENT WAS ADMITTED FOR HEART FAILURE. AN ECHOCARDIOGRAM WAS PERFORMED AND REVEALED MODERATE-SEVERE AORTIC VALVE INSUFFICIENCY. THE PATIENT WAS TREATED FOR CONGESTIVE HEART FAILURE AND WORKUP WAS PERFORMED IN PREPARATION FOR AN AORTIC VALVE REPLACEMENT. THE PRE-OPERATIVE ECHOCARDIOGRAM SHOWED A PEAK VELOCITY ACROSS THE AORTIC VALVE OF 2.1M/SEC WITH A PEAK GRADIENT OF 18MM HG, AND A MEAN GRADIENT OF 10MM HG. THE CALCULATED AORTIC VALVE ANNULUS (AVA) WAS 1.5CM2 AND AN EJECTION FRACTION OF 40% AND SEVERE AORTIC INSUFFICIENCY. SUBSEQUENTLY, APPROXIMATELY EIGHT YEARS, ONE WEEK FOLLOWING IMPLANT OF THE MEDTRONIC VALVE, A 26MM NON-MEDTRONIC VALVE WAS IMPLANTED. A BLOOD TEST SHOWED THE BRAIN NATRIURETIC PEPTIDE WAS ELEVATED AT 918MG/ML. THE POST-OPERATIVE ECHOCARDIOGRAM SHOWED A PEAK VELOCITY OF 1.5M/SEC, A PEAK GRADIENT OF 9MM HG, AND A MEAN GRADIENT 6MM HG. THE CALCULATED AVA WAS 2.0CN2 AND NO SIGNIFICANT PARAVALVULAR LEAK. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
ADDITIONAL INFORMATION WAS RECEIVED WHICH INDICATED THAT THE ACTIVE TRANSCATHETER VALVE PRIOR TO THIS CURRENT REVISION HAD BEEN PREVIOUSLY IMPLANTED VALVE-IN-VALVE (SEE MANUFACTURER REPORT # 2025587-2015-00926). FOUR DAYS FOLLOWING THE RECENT NON-MEDTRONIC VALVE-IN-VALVE IMPLANT VENTRICULAR FIBRILLATION IDENTIFIED VIA TELEMETRY MONITORING. THE PATIENT WAS PULSELESS AND UNRESPONSIVE. DO NOT RESUSCITATE (DNR) WAS IN PLACE AND THE PATIENT¿S DEATH WAS DECLARED. PER THE PHYSICIAN THE DEATH WAS UNRELATED TO THE MEDTRONIC VALVE AND PROCEDURE. THE DEATH WAS REPORTED AS A CARDIOVASCULAR DEATH. THE REPORTED CAUSE OF DEATH WAS VENTRICULAR FIBRILLATION.
ADDITIONAL INFORMATION WAS RECEIVED WHICH INDICATED THAT IN REGARDS TO THE REPORTED ACUTE CONGESTIVE HEART FAILURE INTRAVENOUS (IV) DIURETIC WAS ADMINISTERED TWICE DAILY. THE B-TYPE NATRIURETIC PEPTIDE 1,348 PICOGRAMS PER MILLILITER (PG/ML) WITH A REFERENCED NORMAL RANGE OF 0-100 PG/ML. AN ECHOCARDIOGRAM WITH CONTRAST WAS PERFORMED ONE DAY LATER. THIS IDENTIFIED AN EJECTION FRACTION OF 35-40% WITH MODERATE TO SEVERE PARAVALVULAR LEAK (PVL). CHEST PAIN OCCURRED WHICH WAS REPORTED AS RELATED TO DEMAND ISCHEMIA IN THE SETTING OF THE HEART FAILURE. A CARDIAC CATHETERIZATION WAS DONE PRIOR TO THE REVISION WHICH DID NOT REVEAL ANY DISEASE THAT REQUIRED ANY INTERVENTION. APPROXIMATELY TWO DAYS LATER, THE HEART FAILURE SYMPTOMS IMPROVED, AND THE DIURETIC WAS DECREASED TO 40 MG DAILY VIA ORAL ADMINISTRATION. THE PHYSICIAN INDICATED THE HEART FAILURE WAS RELATED TO THE TRANSCATHETER VALVE. WITH THE MEDTRONIC VALVE REVISION WITH THE NON-MEDTRONIC TRANSCATHETER VALVE IMPLANTED VALVE-IN-VALVE, THE MITRAL REGURGITATION (MR) WAS DECREASED TO TRACE. PER THE PHYSICIAN THE MEDTRONIC VALVES HAD NOT CAUSED OR CONTRIBUTED TO THE MITRAL REGURGITATION. NO AORTIC STENOSIS AND THE MEAN ATRIO-VENTRICULAR GRADIENT WAS REPORT NOW AS 8 MMHG. ON THE DAY OF THE MEDTRONIC TRANSCATHETER VALVE REVISION WITH A NON-MEDTRONIC TRANSCATHETER VALVE IMPLANTED VALVE-IN-VALVE, FOLLOWING THIS REVISION, PREMATURE VENTRICULAR CONTRACTIONS (PVCS) OCCURRED. FURTHER, PULSELESS ELECTRICAL ACTIVITY (PEA) ARREST OCCURRED. POLYMORPHIC VENTRICULAR TACHYCARDIA ARREST ALSO WAS REPORTED WHICH LASTED FOR APPROXIMATELY 25 MINUTES. AN EJECTION FRACTION OF 20-25% WAS IDENTIFIED. CARDIOPULMONARY RESUSCITATION (CPR), DEFIBRILLATIONS, AND MEDICATION WERE ADMINISTERED. THE RESUSCITATION WAS SUCCESSFUL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2209172 | EVOLUT R TRANSCATHETER AORTIC VALVE | AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV | NPT | MEDTRONIC HEART VALVES DIVISION | EVOLUTR-29-C |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 88 YR | Male | Life Threatening| R| H| D |