EVOLUT R TRANSCATHETER AORTIC VALVE
Report
- Report Number
- 2025587-2022-01021
- Event Type
- Death
- Date Received
- April 19, 2022
- Date of Event
- April 13, 2022
- Report Date
- September 22, 2022
- Manufacturer
- MEDTRONIC HEART VALVES DIVISION
- Product Code
- NPT
- PMA / PMN Number
- P130021
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PK
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
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.
CONCLUSION: THE EXPLANTED VALVE WAS NOT RETURNED TO MEDTRONIC. IMAGES WERE PROVIDED TO MEDTRONIC FOR REVIEW. REVIEW OF THE RETURNED ANGIOGRAPHY IMAGES SHOWED A VALVE LOAD WITH AN ACCEPTABLE LOAD. THE PRE BALLOON AORTIC VALVULOPLASTY WAS SEEN ON IMAGING. IT APPEARED NO RECAPTURES WERE SEEN IN THE ANGIOGRAPHY, AS REPORTED. IMAGING OF THE POST AORTIC VALVULOPLASTY OF AN UNKNOWN BALLOON SIZE WAS PROVIDED, AS REPORTED. THE TRANSESOPHAGEAL ECHOCARDIOGRAMS (TEE) RECEIVED WERE REVIEWED AND ALL COLOR FLOW DOPPLER COMPUTATIONAL FLUID DYNAMICS (CFD) IMAGES, WITH WHAT APPEARED TO BE THE CFD SCALE SET TOO LOW FOR ACCURATE REGURGITATION ASSESSMENT. THE CFD SCALE WAS SET TO 35.3 CM/S. THE AMERICAN SOCIETY OF ECHOCARDIOGRAPHY RECOMMENDS THE CFD SCALE TO BE SET AT 50/70 CM/S. REGURGITATION APPEARS A LOT WORSE WHEN THE CFD SCALE IS SET TOO LOW. THE TEE FINDINGS SHOWED SIGNIFICANT CENTRAL PROSTHETIC LEAFLET REGURGITATION AND SIGNIFICANT MITRAL REGURGITATION. MEDTRONIC IS UNABLE TO QUANTIFY THE REGURGITATION WITH THE CFD SCALE SET TOO LOW. IN THE TEE, THE LEAFLETS ARE NOT COAPTING. REVIEW OF THE RETURNED STILL PICTURES OF THE EXPLANTED VALVE BY MEDTRONIC¿ RESEARCH AND DEVELOPMENT (R<(>&<)>D) MANAGER AND VALVE TISSUE PERSONNEL FEEL THAT THE VALVE DID NOT EXHIBIT POST IMPLANT DILATATION INDUCED DAMAGE OR TEARING SIGNS THAT WOULD HAVE LED TO CENTRAL AORTIC REGURGITATION. HOWEVER, WITHOUT THE ACTUAL RETURNED VALVE FOR ANALYSIS, THIS WAS NOT ABLE TO BE CONFIRMED. IT SHOULD ALSO BE NOTED THAT ONE LEAFLET THAT WAS NOT COAPTING, IN THE PICTURES, IS NOT UNDER PHYSIOLOGICAL "BACK PRESSURES" AS SEEN DURING DIASTOLE WHEN THE VALVE IS IMPLANTED. THEREFORE IS NOT CONSIDERED TO BE FAULTY FROM WHAT MEDTRONIC CAN DETERMINE FROM THE PICTURES. A CUT OR CREASE IN ONE OF THE FREE MARGINS OF THIS SAME LEAFLET WAS SEEN. REVIEW WITH R<(>&<)>D TISSUE PERSONNEL, FEEL THAT THIS DAMAGE MOST LIKELY OCCURRED WHEN THE VALVE WAS BEING REMOVED FROM THE PATIENT, HOWEVER, MEDTRONIC WAS UNABLE TO REVIEW A GOOD VISUAL ON THIS AREA WITHOUT THE EXPLANTED VALVE IN QUESTION RETURNED FOR ANALYSIS. IT SHOULD BE NOTED THAT WHILE MEDTRONIC WAS NOT PROVIDED THE SIZE AND MANUFACTURER OF THE BALLOON AORTIC VALVULOPLASTY (BAV) USED FOR THE POST IMPLANT DILATATION, THE ¿CUT OR CREASE¿ TO THE FREE MARGIN OF ONE LEAFLET, DOES NOT APPEAR TO BE RELATED TO A POST IMPLANT DILATATION, AS THIS IS NOT TYPICAL DAMAGE AS SEEN ON OTHER RETURNED VALVES IN WHICH THE USER DID NOT FOLLOW THE INSTRUCTIONS FOR USE (IFU) POST -IMPLANT BALLOON DILATATION SIZING. AGAIN, THE ¿CUT OR CREASE¿ ON THE FREE MARGIN OF THE VALVE LEAFLET MOST LIKELY OCCURRED WHILE THE VALVE WAS BEING EXPLANTED FROM THE PATIENT, FURTHER CONFIRMED BY THE STATEMENT BY THE USER THAT THE VALVE WAS VISUALLY INSPECTED AND RINSED WITH NO ABNORMALITIES OBSERVED. WITHOUT THE RETURN OF THE EXPLANTED VALVE, THE CAUSE FOR THE ANOMALY ON THE VALVE LEAFLET FREE MARGIN, NOTED IN THE STILL PICTURES OF THE EXPLANTED VALVE WAS NOT ABLE TO BE CONFIRMED. WHILE REGURGITATION WAS NOTED IN THE ANGIOGRAPHIC IMAGES, THE QUANTITY OF THIS REGURGITATION WITH THE CDF SCALE SET TOO LOW WAS NOT ABLE TO BE DETERMINED. THE EXACT CAUSE FOR THE INCOMPLETE COAPTATION THAT WAS NOTED BOTH IN THE RETURNED ANGIOGRAPHIC IMAGES AND THE EVENT DESCRIPTION WAS ALSO NOT ABLE TO BE DETERMINED. IN THIS EVENT IT WAS REPORTED THAT THE PATIENT DEATH WAS DUE TO SEVERE AORTIC REGURGITATION, THAT LED TO HEART FAILURE AND DEATH, AFTER A SECOND NON-MEDTRONIC VALVE WAS IMPLANTED. 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 TRANSCATHETER AORTIC VALVE IS NEEDED TO SUSTAIN CARDIAC FUNCTION, AND IT CAN OCCUR DESPITE AN IDEAL IMPLANT PROCEDURE OR DEVICE FUNCTIONALITY. 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. 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 INDICATED THAT A PRE-BALLOON AORTIC VALVULOPLASTY (BAV) WAS PERFORMED. THIS INCLUDED ONE INFLATION WITH AN 18 MILLIMETER (MM) NON-MEDTRONIC BALLOON. AS REPORTED, FREE FLOW AORTIC REGURGITATION VIA THE TRANSESOPHAGEAL ECHOCARDIOGRAM NOTED THE LEAFLETS WERE NOT COAPTING. DURING THE SURGICAL REVISION, A SURGEON INDICATED THAT ONE OF THE LEAFLETS WAS "STUCK". ULTIMATELY, THE PATIENT DIED THE DAY FOLLOWING THE VALVE PROCEDURE. UPDATED DATA: B2, H1, H6- ANNEX F CODES. 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.
UPDATED DATA: B5. ADDITIONAL INFORMATION WAS RECEIVED THAT PRIOR TO USE, THE VALVE WAS VISUALLY INSPECTED AND RINSED; NO ABNORMALITIES WERE OBSERVED. IT WAS CONFIRMED THE VALVE WAS NOT RECAPTURED DURING THE PROCEDURE. FOLLOWING EXPLANT OF THE VALE, A NON-MEDTRONIC SURGICAL VALVE WAS PLACED. THE CAUSE OF DEATH WAS SEVERE AORTIC REGURGITATION (AR) CAUSING HEMODYNAMIC COMPROMISE. PER THE PHYSICIAN, THE MEDTRONIC VALVE CAUSED SEVERE AR WHICH LED TO HEART FAILURE AND DEATH. E2. CORRECTED THE HCP STATUS FROM WHAT WAS SUBMITTED IN THE FIRST SUPPLEMENTAL REPORT H3. DUE TO LOCAL REGULATION, THE DEVICE WILL NOT BE RETURNED. 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. 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 RECEIVED INFORMATION THAT DURING IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, FOLLOWING VALVE DEPLOYMENT SEVERE AORTIC REGURGITATION (AR) WAS OBSERVED VIA ANGIOGRAM THROUGH THE PIG TAIL CATHETER. THE MEDTRONIC GUIDEWIRE WAS REMOVED AND A SECOND ANGIOGRAM SHOWED THE AR REMAINED. A POST-IMPLANT BALLOON AORTIC VALVULOPLASTY WAS PERFORMED. UPON ASSESSMENT OF THE ECHOCARDIOGRAM, IT WAS UNCLEAR IF THE AR WAS PARAVALVULAR LEAK OR CENTRAL REGURGITATION. CONSULTATION WITH ANOTHER PHYSICIAN SUGGESTED A TRANSESOPHAGEAL ECHOCARDIOGRAM (TOE) BE PERFORMED. FOLLOWING TOE AND SECONDARY DISCUSSION, CENTRAL AR WAS CONFIRMED, BUT THERE WAS ALSO AN ISSUE WITH THE VALVE LEAFLETS. A DECISION WAS MADE TO SURGICALLY EXPLANT THE VALVE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1273960 | EVOLUT R TRANSCATHETER AORTIC VALVE | AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV | NPT | MEDTRONIC HEART VALVES DIVISION | EVOLUTR-26 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 74 YR | Male | Death| R |