EVOLUT FX DCS
Report
- Report Number
- 2025587-2024-00805
- Event Type
- Malfunction
- Date Received
- February 12, 2024
- Date of Event
- February 2, 2024
- Report Date
- March 7, 2024
- Manufacturer
- MEDTRONIC HEART VALVES DIVISION
- Product Code
- NPT
- UDI-DI
- 00763000365677
- PMA / PMN Number
- P130021
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
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.
CONTINUATION OF D10: PRODUCT ID: EVOLUTFX-29 (SERIAL: (B)(6)); PRODUCT TYPE: 0195-HEART VALVES. PRODUCT ID: EVOLUTFX-26 (SERIAL: (B)(6)); PRODUCT TYPE: 0195-HEART VALVES; PRODUCT ID: D-EVOLUTFX-2329 (0012032046); PRODUCT TYPE: 0195-HEART VALVES. MEDTRONIC HAS REQUESTED ADDITIONAL INFORMATION PERTAINING TO THIS REPORTABLE EVENT. IF ADDITIONAL REPORTABLE INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. 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 THAT THE FIRST VALVE (J081220) WAS RECAPTURED THE FIRST 2 TIMES DUE TO THE VALVE LANDING TOO HIGH, APPROXIMATELY 1 MILLIMETER (MM) OR LESS BOTH TIMES. A PRE-IMPLANT BALLOON AORTIC VALVULOPLASTY (BAV) WAS NOT PERFORMED PRIOR TO THE ATTEMPTED IMPLANT OF THE FIRST VALVE. THE PATIENT HAD SEVERE ANNULAR AND LEFT VENTRICULAR OUTFLOW TRACT (LVOT) CALCIFICATION THAT CONTRIBUTED TO BOTH DISLODGEMENTS. THE DEPLOYMENT STARTING POINT WAS AT THE BOTTOM OF THE PIGTAIL CATHETER, AND THE IMPLANT DEPTH ON THE NON-CORONARY CUSP (NCC) WAS 1 MM AND THE IMPLANT DEPTH ON THE LEFT CORONARY CUSP (LCC) WAS -2 MM. ADDITIONALLY, A SMALL CURVE NON-MEDTRONIC (SAFARI) GUIDEWIRE WAS USING DURING THE PROCEDURE WITH BOTH SYSTEMS. PRIOR TO THE ATTEMPTED IMPLANT OF THE SECOND VALVE (J118270), A PRE-IMPLANT BAV WAS NOT PERFORMED BECAUSE THE MEAN GRADIENT WAS ONLY 40 MMHG FROM THE BEGINNING OF THE PROCEDURE. DURING THE FIRST DEPLOYMENT ATTEMPT OF THE 26 MM VALVE, THE VALVE DISLODGED SUPRA ANNULAR. FOLLOWING THE FIRST DEPLOYMENT ATTEMPT WHICH STARTED AT THE BOTTOM OF THE PIGTAIL CATHETER, THE IMPLANTING TEAM STARTED THE DEPLOYMENT APPROXIMATELY 3-4 MM DEEPER ON THE SECOND DEPLOYMENT ATTEMPT. IT WAS HARD TO ASSESS THE DEPTH OF THE VALVE AFTER IT DISLODGED BECAUSE THE VALVE WAS BEING PUSHED UP ABOVE THE ANNULUS. NO ADVERSE PATIENT EFFECTS WERE REPORTED.
MEDTRONIC RECEIVED INFORMATION THAT DURING THE ATTEMPTED IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, IN A HEAVILY CALCIFIED ANNULUS AND LEFT VENTRICULAR OUTFLOW TRACT (LVOT), MULTIPLE ATTEMPTS WERE MADE TO DEPLOY THE VALVE (J081220). AFTER THE THIRD DEPLOYMENT ATTEMPT, THE VALVE DISLODGED AORTIC. AFTER DISCUSSION, DUE TO THE AMOUNT OF CALCIUM PRESENT IN THE LVOT, A 26-MILLIMETER (MM) VALVE (J118270 ) WAS DEEMED AS A BETTER FIT. THE VALVE WAS LOADED ONTO A NEW DELIVERY CATHETER SYSTEM (DCS). THE VALVE WAS ATTEMPTED TO BE DEPLOYED BUT THE VALVE SUBSEQUENTLY DISLODGED AORTIC. DURING BOTH DEPLOYMENT ATTEMPTS OF EACH VALVE, CUSPAL OVERLAP TECHNIQUE WAS USED. AFTER THE SECOND DEPLOYMENT WAS ATTEMPTED WITH THE 26 MM VALVE, THE VALVE WAS PLACED TOO DEEP. IT WAS NOTED THAT THE VALVE WAS PLACED LOWER THAN -10 MM. A PARTIAL RECAPTURE WAS PERFORMED, AND THE IMPLANTING TEAM WAS SUCCESSFUL AT PLACING THE VALVE, BUT IT WAS STILL TOO DEEP TO DEPLOY. THE 26 MM VALVE WAS RECAPTURED AND WITHDRAWN FROM THE PATIENT. A DECISION WAS MADE BY THE PHYSICIAN TO ABORT THE PROCEDURE AND DISCUSS THE POSSIBILITY OF A SURGICAL AORTIC VALVE REPLACEMENT (SAVR), OR A TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) USING A NON-MEDTRONIC VALVE. THE PROCEDURE WAS TERMINATED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 781738 | EVOLUT FX DCS | AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV | NPT | MEDTRONIC HEART VALVES DIVISION | D-EVOLUTFX-2329 | 0011810528 | 00763000365677 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 78 YR | Male |