EVOLUT PRO PLUS VALVE
Report
- Report Number
- 2025587-2021-03754
- Event Type
- Death
- Date Received
- December 15, 2021
- Date of Event
- December 3, 2021
- Report Date
- April 20, 2022
- 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
UPDATED DATA: B5. ADDITIONAL INFORMATION WAS RECEIVED THAT THE POST-IMPLANT BAV WAS PERFORMED WITH A 23MM NON-MEDTRONIC BALLOON DUE TO RESIDUAL PARAVALVULAR LEAK. IT WAS REPORTED PCPS WAS REMOVED THE SAME DAY AS THE VALVE IMPLANT PROCEDURE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. H6. PATIENT CODE ADDED. 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.
THE DATE MFT REC WAS CORRECTED IN G3 FOR THE INFORMATION SENT ON REPORT 2025587-2021-03754-001. 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.
ADDITIONAL INFORMATION WAS RECEIVED THAT A SHUNT REMAINED WITHIN THE RIGHT VENTRICLE (RV) FOLLOWING THE SURGICAL REPAIR. IT WAS REPORTED THAT THE ISSUE GRADUALLY WORSENED. 48 DAYS FOLLOWING THE VALVE IMPLANT, THE PATIENT DIED OF HEART FAILURE. THE PHYSICIAN ATTRIBUTES THE DEATH TO THE VALVE. UPDATED 2. UPDATED B5. UPDATED H1. UPDATED H6. 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.
ADDITIONAL INFORMATION WAS RECEIVED REPORTING THAT THE PARAVALVULAR LEAK (PVL) GRADUALLY WORSENED DURING THE PROCEDURE AND WAS SEVERE PRIOR TO THE POST-IMPLANT BALLOON AORTIC VALVULOPLASTY (BAV). THE PVL REMAINED SEVERE FOLLOWING THE POST-IMPLANT BAV. 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.
ADDITIONAL INFORMATION WAS RECEIVED WHICH REPORTED THAT THE CAUSE OF THE HEART FAILURE WAS DETERIORATION OF THE PVL. UPDATED B5. 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.
CONCLUSION: THE VALVE REMAINS IMPLANTED, THEREFORE NO PRODUCT ANALYSIS CAN BE PERFORMED. IMAGES WERE NOT RECEIVED FOR MEDTRONIC TO REVIEW. PARAVALVULAR LEAK (PVL) CAN BE CAUSED BY A VARIETY OF FACTORS, INCLUDING VALVE POSITIONING, PATIENT ANATOMY, CALCIFICATION LEVEL OR PRESENCE OF PRE-EXISTING PATIENT CONDITIONS. CARDIOVASCULAR INJURIES, INCLUDING RUPTURE, ARE KNOWN POTENTIAL ADVERSE PATIENT EFFECTS PER THE INSTRUCTIONS FOR USE (IFU), AND MAY BE IMPACTED BY MANY FACTORS INCLUDING THE PATIENT'S PRE-PROCEDURAL CONDITION, ANATOMICAL FACTORS, IN ADDITION TO PROCEDURAL AND DEVICE FACTORS. IN THIS CASE, IT WAS REPORTED THAT THE ANNULUS RUPTURED FOLLOWING THE POST-IMPLANT BAV. THE DEVICE IFU STATES: "IF VALVE FUNCTION OR SEALING IS IMPAIRED DUE TO EXCESSIVE CALCIFICATION OR INCOMPLETE EXPANSION, A POST-IMPLANT BALLOON DILATATION (PID) OF THE BIOPROSTHESIS MAY IMPROVE VALVE FUNCTION AND SEALING." IFU CAUTION: OVEREXPANSION OF THE NARROWEST PORTION (WAIST) OF THE EVOLUT PRO+ VALVE BEYOND THE LEVELS SET FORTH IN THE IFU HAS BEEN DEMONSTRATED THROUGH BENCH DATA TO CAUSE DAMAGE TO THE BIOPROSTHETIC LEAFLETS. COMPLAINTS OF DAMAGE TO THE BIOPROSTHETIC LEAFLETS DURING POST-IMPLANT BALLOON DILATATION HAVE BEEN REPORTED IN SOME CLINICAL CASES, RESULTING IN MODERATE TO SEVERE AORTIC INSUFFICIENCY, WHICH MAY BE DETECTED ACUTELY OR DURING FOLLOW-UP. IT IS IMPORTANT TO NOTE THAT THE MECHANICAL COMPLIANCE PROPERTIES OF THE SELECTED BALLOON INFLUENCE THE DILATATION DYNAMICS. BALLOONS SHOULD NOT BE INFLATED BEYOND 2 ATM OF APPLIED PRESSURE. COMPLIANT AND SEMI-COMPLIANT (SOFTER) BALLOONS WILL MORE READILY CONFORM TO THE HOURGLASS PROFILE OF THE BIOPROSTHESIS VALVE AT LOWER PRESSURES BUT MUST BE INFLATED AT PRESSURES THAT PRESERVE THE HOURGLASS PROFILE OF THE TAV. CONVERSELY, NON-COMPLIANT (STIFFER) BALLOONS WILL ACHIEVE THE NOMINAL DIAMETER DURING INFLATION IRRESPECTIVE OF THE UNDERLYING ANNULUS OR BIOPROSTHESIS VALVE RESISTANCE AND SHOULD BE DOWNSIZED. FOR ADDITIONAL INSTRUCTIONS ON THE USE OF BALLOON CATHETER DEVICES REFER TO THE SPECIFIC BALLOON CATHETER MANUFACTURER'S LABELING. IN THE EVENT THAT LARGER BALLOON DIAMETERS THAN THOSE LISTED IN THE IFU ARE REQUIRED TO EXPAND THE EVOLUT PRO+ VALVE DUE TO CLINICALLY IMPORTANT RESIDUAL AORTIC REGURGITATION OR STENOSIS, USING ¿BAILOUT¿ INTRAVENTRICULAR BALLOON POSITIONING WHEN PERFORMING POST IMPLANT DILATION (PID) AVOIDS EXPANSION OF THE NARROWEST PORTION (WAIST) OF THE EVOLUT PRO+ VALVE. THIS CAN MITIGATE THE RISK OF LEAFLET DAMAGE. DILATATION WITH INTRAVENTRICULAR BALLOON POSITIONING SHOULD BE PERFORMED WITH CAUTION IN THE SETTING OF A SMALLER VENTRICLE CAVITY, PRESENCE OF LEFT VENTRICULAR OUTFLOW TRACT (LVOT) CALCIFICATION, OR WIRE POSITIONING THAT INTERFERES WITH MITRAL VALVE FUNCTION, TO AVOID ANY UNINTENDED BALLOON INTERACTION WITH ANATOMY. THE BALLOON¿S LENGTH AND DIAMETER, ALONG WITH THE INDIVIDUAL PATIENT ANATOMY, MUST BE CONSIDERED. CARE SHOULD ALSO BE TAKEN NOT TO EXCEED THE ANNULAR DIAMETERS WHEN PERFORMING PID WITH INTRAVENTRICULAR BALLOON POSITIONING. IF A BAILOUT PID WITH INTRAVENTRICULAR BALLOON POSITIONING IS PERFORMED, THE NOMINAL DIAMETER OF THE BALLOON SHOULD NOT EXCEED THE ANNULAR DIAMETER WHEN USING COMPLIANT OR SEMI-COMPLIANT BALLOONS; THE NOMINAL DIAMETER OF THE BALLOON SHOULD BE AT LEAST 1 MM SMALLER THAN THE ANNULAR DIAMETER WHEN USING NON-COMPLIANT BALLOONS. BASED ON THE EVENT DESCRIPTION INFORMATION, PRELIMINARY ASSESSMENTS OF THE CAUSE(S) OF THE ANNULAR DAMAGE REPORTED IN THE EVENT DESCRIPTION SUGGEST THAT A POST VALVE DEPLOYMENT INTERVENTION IS POSSIBLY AMONG THE FACTORS LEADING TO THE DAMAGE OF THE ANNULUS AND SUBSEQUENT HYPOTENSION. IT WAS STATED THAT THE USER USED A Z-MED BALLOON, WHICH IS WHAT IS CALLED A "COMPLIANT OR SEMI-COMPLIANT" BALLOON. A COMPLIANT OR SEMI-COMPLIANT BALLOON SHOULD NOT EXCEED THE DIAMETER OF THE NATIVE AORTIC ANNULUS. PER IFU; POST-IMPLANT BALLOON DILATATION SIZING, THE MAXIMUM BALLOON SIZE CHOSEN FOR DILATATION USING A COMPLIANT AND SEMI-COMPLIANT BALLOON FOR THE 26MM EVOLUT PRO+ VALVE, IS 20-23MM WITH AN APPLIED INFLATION PRESSURE OF NO GREATER THAN 2 ATM. IN THIS CASE, THE USER FOLLOWED THE IFU AND USED THE APPROPRIATELY SIZED BALLOON, HOWEVER, WE WERE NOT MADE AWARE OF THE INFLATION PRESSURES USED WITH 23MM BALLOON. HYPOTENSION IS A KNOWN POTENTIAL ADVERSE EFFECT PER THE DEVICE IFU. IT IS AN EFFECT THAT IS HIGHLY DEPENDENT ON THE PATIENT'S PRE-PROCEDURAL CONDITION AND CAN OCCUR DESPITE A NORMALLY-FUNCTIONING DEVICE OR MODEL IMPLANT PROCEDURE. THE HYPOTENSION WAS LIKELY RELATED TO THE REPORTED ANNULAR RUPTURE. IN THIS CASE, IT INDICATES THAT THE POST BAV MAY HAVE CONTRIBUTED TO THE ANNULUS DAMAGE AND LED TO THE HYPOTENSION. COMPLETE HEART BLOCK (CHB) WAS ALSO REPORTED ON THE DAY OF THE PROCEDURE. CONDUCTION DISTURBANCES, SUCH AS CHB ARE ALSO KNOWN POTENTIAL ADVERSE EFFECTS PER THE DEVICE IFU AND CAN BE RESOLVED WITH THE IMPLANT OF A PERMANENT PACEMAKER WITH THE RISK-BENEFIT RATIO IN FAVOR OF THE TAV. FACTORS THAT MAY IMPACT THE DEVELOPMENT OF CONDUCTION DISTURBANCES INCLUDE DEPTH OF IMPLANT, BASELINE CONDUCTION DEFECTS, AND ANATOMICAL CONSIDERATIONS. IT WAS REPORTED THAT 48 DAYS FOLLOWING THE VALVE IMPLANT, THE PATIENT DIED OF HEART FAILURE. THE PHYSICIAN ATTRIBUTES THE DEATH TO THE VALVE. HEART FAILURE IS LISTED IN THE DEVICE IFU UNDER POTENTIAL ADVERSE EVENTS, AND CAN BE RELATED TO SEVERAL FACTORS (PROCEDURE, PATIENT COMORBIDITIES, ETC.). IT WAS REPORTED THAT THE CAUSE OF THE HEART FAILURE WAS DETERIORATION OF THE PVL. AS NEITHER AN AUTOPSY NOR AN EXPLANT WAS PERFORMED, A CONCLUSIVE ASSESSMENT OF THE RELATIONSHIP BETWEEN THE EVENT AND THE DEVICE COULD NOT BE REACHED. A PROCEDURE- OR VALVE-RELATED DEATH IS AN INHERENT RISK WHEN THE PATIENT CONDITION IS SUCH THAT A TAV IS NEEDED TO SUSTAIN CARDIAC FUNCTION, AND IT CAN OCCUR DESPITE AN IDEAL IMPLANT PROCEDURE OR DEVICE FUNCTIONALITY. THE PHYSICIAN REPORTED THAT THE CAUSE OF DEATH WAS DUE TO HEART FAILURE. THE PHYSICIAN ATTRIBUTES THE DEATH TO THE VALVE. HOWEVER, WITH THE INFORMATION AVAILABLE, THERE WAS NO INDICATION THAT A MALFUNCTION OR MISUSE CONTRIBUTED TO THE REPORTED EVENTS. WITH THE LIMITED INFORMATION AVAILABLE, A RELATIONSHIP BETWEEN THE DEVICE AND THE DEATH COULD NOT BE ESTABLISHED. THE DEVICE HISTORY RECORD FOR THE VALVE WAS REVIEWED AND SHOWED THAT THIS DEVICE MET ALL MANUFACTURING SPECIFICATIONS FOR PRODUCT RELEASED FOR DISTRIBUTION. NO ISSUES WERE IDENTIFIED THAT WOULD HAVE IMPACTED THIS EVENT. THIS EVENT DOES NOT INDICATE DEVICE MISUSE OR MALFUNCTION. UPDATED H6. 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.
PRODUCT ANALYSIS: NO PRODUCT WAS RETURNED. CONCLUSION: WITHOUT THE RETURN OF THE PRODUCT, NO DEFINITIVE CONCLUSION CAN BE MADE REGARDING THE CLINICAL OBSERVATION. . IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
MEDTRONIC RECEIVED INFORMATION THAT IMMEDIATELY FOLLOWING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, THE ANNULUS RUPTURED FOLLOWING A POST-IMPLANT BALLOON AORTIC VALVULOPLASTY (BAV). IT WAS REPORTED THE PATIENT HAD SEVERE CALCIFICATION. PERCUTANEOUS CARDIOPULMONARY SUPPORT (PCPS) WAS INITIATED FOR A DROP IN BLOOD PRESSURE AS A RESULT OF THE RUPTURE. A LEFT VENTRICULAR OUTFLOW TRACT (LVOT) TO RIGHT ATRIUM FISTULA WAS ALSO REPORTED. THE PROCEDURE WAS CONVERTED TO A THORACOTOMY, WHERE HEMOSTASIS WAS ABLE TO BE ACHIEVED. COMPLETE HEART BLOCK (CHB) WAS ALSO REPORTED ON THE DAY OF THE PROCEDURE. A PERMANENT PACEMAKER WAS IMPLANTED SIX DAYS LATER. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1909339 | EVOLUT PRO PLUS VALVE | AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV | NPT | MEDTRONIC HEART VALVES DIVISION | EVPROPLUS-26US |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 88 YR | Female | Required Intervention| D |