EVOLUT FX VALVE
Report
- Report Number
- 2025587-2023-04524
- Event Type
- Injury
- Date Received
- November 1, 2023
- Date of Event
- October 23, 2023
- Report Date
- May 28, 2025
- Manufacturer
- MEDTRONIC HEART VALVES DIVISION
- Product Code
- NPT
- UDI-DI
- 00763000370695
- PMA / PMN Number
- P130021
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
CONCOMITANT PRODUCTS: PRODUCT ID L-EVOLUTFX-2329; PRODUCT LOT/SERIAL NUMBER (B)(6) PRODUCT TYPE: COMPRESSION LOADING SYSTEM (CLS) PRODUCT ID D-EVOLUTFX-2329; PRODUCT LOT/SERIAL NUMBER (B)(6), PRODUCT TYPE: DELIVERY CATHETER SYSTEM (DCS) 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. SECOND PARAGRAPH. 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.
CORRECTED DATA: G2 REPORT SOURCE - STUDY ADDED UPDATED DATA: H6 - ANNEX B, ANNEX C, ANNEX D IMAGES WERE SUBMITTED TO MEDTRONIC FOR REVIEW. THE EXCERPT OF THE IMAGE SUBJECT MATTER EXPERT (SME) REVIEW REPORT FOLLOWS: FOUR MEDIA FILES WERE PROVIDED FOR REVIEW OF THE EVENT. THE PATIENT¿S EXECUTIVE SUMMARY WAS NOT PROVIDED FOR ANATOMICAL REVIEW. THE VALVE WAS DEPLOYED JUST PRIOR TO THE POINT OF NO RECAPTURE AND DEPTH ASSESSMENT WAS PERFORMED. DEPTH AT THE NON-CORONARY CUSP WAS NOTED TO BE APPROXIMATELY 3 MILLIMETER (MM) IN THE CUSP OVERLAP VIEW, AND APPROXIMATELY 3MM AT THE LEFT CORONARY CUSP IN THE LEFT ANTERIOR OBLIQUE (LAO) VIEW. FOR UNKNOWN REASONS, THE VALVE DISLODGED AORTIC AFTER THE FINAL RELEASE. SUBSEQUENTLY, A NEW VALVE WAS IMPLANTED. THE CAUSE OF THE DISLODGEMENT WAS NOT KNOWN. 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.
CORRECTION: H6 - F1904 REMOVED AND REPLACED WITH F23. 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, THE DEPTH OF THE VALVE (J051797) IN CUSP OVERLAP WAS 3MM AND IN COPLANAR VIEW WITH PARALLAX REMOVED THE DEPTH WAS ALSO 3MM. THE VALVE WAS DEPLOYED WHILE PACING AT 160BPM. THE VALVE WAS SUCCESSFULLY DEPLOYED, PACING CEASED AND THE PATIENT RETURNED TO NORMAL CONDUCTION. THE PADDLES RELEASED EASILY AND THE NOSECONE AND DELIVERY CATHETER SYSTEM (DCS) WERE REMOVED FROM THE VALVE AND ASCENDING AORTA WITH NO ISSUE. AS THE DCS CAME TO THE DESCENDING AORTA, THE VALVE DISLODGED ABOVE THE SINOTUBULAR JUNCTION (STJ) WITH NO INTERACTION FROM THE DCS. THE PHYSICIAN ATTEMPTED TO SNARE THE VALVE PADDLE, BUT WAS UNSUCCESSFUL AND DECIDED TO IMPLANT A SECOND VALVE (J051799). THE SECOND VALVE (J051799) SUCCESSFULLY WENT THROUGH THE DISLODGED VALVE (J051797) AND WAS SUCCESSFULLY DEPLOYED. NO PRE-IMPLANT OR POST-IMPLANT BALLOON AORTIC VALVULOPLASTY (BAV) WAS PERFORMED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, THE DEPTH OF THE VALVE IN CUSP OVE RLAP WAS 3MM AND IN COPLANAR VIEW WITH PARALLAX REMOVED THE DEPTH WAS ALSO 3MM. THE VALVE WAS DEPLOYED WHILE PACING AT 160BPM. THE VALVE WAS SUCCESSFULLY DEPLOYED, PACING CEASED AND THE PATIENT RETURNED TO NORMAL CONDUCTION. THE PADDLES RELEASED EASILY AND THE NOSECONE AND DELIVERY CATHETER SYSTEM (DCS) WERE REMOVED FROM THE VALVE AND ASCENDING AORTA WITH NO ISSUE. AS THE DCS CAME TO THE DESCENDING AORTA, THE VALVE DISLODGED ABOVE THE SINOTUBULAR JUNCTION WITH NO INTERACTION FROM THE DCS. THE PHYSICIAN ATTEMPTED TO SNARE THE VALVE PADDLE, BUT WAS UNSUCCESSFUL AND DECIDED TO IMPLANT A SECOND VALVE. THE SECOND VALVE SUCCESSFULLY WENT THROUGH THE DISLODGED VALVE AND WAS SUCCESSFULLY DEPLOYED. NO PRE-IMPLANT OR POST-IMPLANT BALLOON AORTIC VALVULOPLASTY WAS PERFORMED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED THAT A MEDTRONIC GUIDEWIRE WAS USED FOR THE PROCEDURE. IT WAS NOTED THE STARTING POINT FOR VALVE DEPLOYMENT WAS AT THE MIDDLE OF THE PIGTAIL CATHETER. THE ACTIVE/FUNCTIONING VALVE IS IMPLANTED AT A DEPTH OF 6MM ON THE NON-CORONARY CUSP AND 7MM ON THE LEFT CORONARY CUSP.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1928598 | EVOLUT FX VALVE | AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV | NPT | MEDTRONIC HEART VALVES DIVISION | EVOLUTFX-26 | 00763000370695 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 73 YR | Female | Required Intervention | SEE H10. |