EVOLUT FX VALVE
Report
- Report Number
- 2025587-2024-00130
- Event Type
- Injury
- Date Received
- January 9, 2024
- Date of Event
- January 2, 2024
- Report Date
- March 26, 2024
- Manufacturer
- MEDTRONIC HEART VALVES DIVISION
- Product Code
- NPT
- UDI-DI
- 00763000370695
- PMA / PMN Number
- P130021
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
EVENT DESCRIPTION CONTINUATION OF D10: PRODUCT ID 18 MM ZMED II BALLOON (LOT: UNKNOWN); PRODUCT TYPE: DILATION BALLOON; IMPLANT DATE N/A; EXPLANT DATE N/A PRODUCT ID 20 MM ZMED II BALLOON (LOT: UNKNOWN); PRODUCT TYPE: DILATION BALLOON; IMPLANT DATE N/A; EXPLANT DATE N/A H6 - PATIENT AND DEVICE CODES ADDITIONAL CODES - IMG COMPONENT CODE 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: L-EVOLUTFX-2329 (LOT: 0011827953), PRODUCT TYPE: 0195-HEART VALVES; PRODUCT ID: D-EVOLUTFX-2329 (LOT: 0011827947), PRODUCT TYPE: 0195-HEART VALVES. 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: H6 - METHOD, RESULT AND CONCLUSION CODES CONCLUSION: THE DEVICE HISTORY RECORD WAS REVIEWED AND SHOWED THIS PRODUCT MET ALL MANUFACTURING SPECIFICATIONS FOR PRODUCT RELEASED FOR DISTRIBUTION. NO ISSUES WERE IDENTIFIED THAT WOULD HAVE IMPACTED THIS EVENT. MEDIA FILES WERE PROVIDED FOR REVIEW OF THE EVENT DESCRIPTION. PATIENT¿S EXECUTIVE SUMMARY WAS PROVIDED FOR ANATOMICAL REVIEW. PATIENT ANNULUS PERIMETER MEASURED 68.5 MILLIMETER (MM) WITH A PERIMETER DERIVED DIAMETER OF 21.8MM SUGGESTING A 26MM EVOLUT. IT APPEARS THE PATIENT HAD A CALCIFIED SIEVERS TYPE 0 BICUSPID AORTIC VALVE AND ANNULAR CALCIUM EXTENDING TO THE LEFT VENTRICULAR OUTFLOW TRACK. FLUOROSCOPIC VALVE LOAD INSPECTION WAS PERFORMED AND CONFIRMED A GOOD LOAD. IT WAS REPORTED THAT PRE BALLOON VALVULOPLASTY WAS PERFORMED TWICE PRIOR TO THE VALVE IMPLANT. DESPITE THE PRE DILATATIONS, THE VALVE DID NOT SEEM TO EXPAND. IT WAS REPORTED THAT THE UNDER EXPANDED VALVE WAS NOT DEPLOYED, AND A NEW VALVE WAS USED FOR THE IMPLANT. HOWEVER, IT DISLODGED AORTIC CAUSING SIGNIFICANT AORTIC INSUFFICIENCY. THE PATIENT WAS CONVERTED TO SURGERY. THE INSTRUCTIONS FOR USE (IFU) STATES THAT POTENTIAL RISKS ASSOCIATED WITH THE IMPLANTATION OF THE EVOLUT FX BIOPROSTHESIS MAY INCLUDE, BUT ARE NOT LIMITED TO, THE FOLLOWING: EMERGENT SURGICAL OR TRANSCATHETER INTERVENTION (FOR EXAMPLE, CORONARY ARTERY BYPASS, HEART VALVE REPLACEMENT, VALVE EXPLANT, PERCUTANEOUS CORONARY INTERVENTION [PCI], BALLOON VALVULOPLASTY). PROSTHETIC VALVE MIGRATION/EMBOLIZATION. POTENTIAL FACTORS THAT CAN INFLUENCE A DISLODGED VALVE INCLUDE TENSION APPLIED ON THE DELIVERY CATHETER SYSTEM (DCS) DURING POSITIONING, CALCIFICATION LEVELS IN THE NATIVE VESSEL, COMPLIANCE OF THE AORTA AND NATIVE VESSELS, AND A NUMBER OF OTHERS. IN THIS CASE, NO DEFINITIVE ROOT CAUSE CAN BE DETERMINED, HOWEVER THE PATIENT¿S CALCIFIED BICUSPID ANATOMY IS LIKELY A CONTRIBUTING FACTOR. 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.
ADDITIONAL INFORMATION WAS RECEIVED THAT DURING THE VALVE IMPLANT, TWO PRE IMPLANT DILATIONS WERE PERFORMED WITH AN 18 MILLIMETER (MM) BALLOON (ZMED II). DUE TO HEAVY CALCIFIED ANATOMY, THE VALVE (J013214) DID NOT OPEN PROPERLY AND DID NOT DISLODGE. OF NOTE, THE PATIENT HAD A HORIZONTAL AORTA AND THICKENED ANNULUS CALCIUM EXTENDING INTO THE LEFT VENTRICULAR OUTFLOW TRACT (LVOT) AND MINIMUM DIAMETER OF ANNULUS LVOT IS 18.7 MM. THE VALVE WAS RECAPTURED MORE THAN THREE TIMES AND THE SYSTEM WAS WITHDRAWN FROM THE PATIENT AND REPLACED AS RECOMMENDED. ANOTHER PRE IMPLANT DILATION WAS PERFORMED WITH A LARGER 20 MM BALLOON (ZMED II). A NEW VALVE (J013213) WAS USED AND DEPLOYED AROUND 4-5 MILLIMETER (MM) DEPTH BUT DISLODGED FROM THE ANNULUS AS THE THICKENED CALCIUM IN THE ANNULUS WAS MORE THAN EXPECTED. SUBSEQUENTLY THE PATIENT WAS CONVERTED TO SURGERY AND THE VALVE WAS REPLACED WITH A SURGICAL VALVE. THE PATIENT WAS REPORTED TO BE DOING WELL AND WAS DISCHARGED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
MEDTRONIC RECEIVED INFORMATION THAT DURING IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE ((B)(6)), THE VALVE DISLODGED. SUBSEQUENTLY THE VALVE WAS REPLACED WITH A NEW VALVE ((B)(6)). IT WAS REPORTED THAT THIS VALVE WAS EXPLANTED FOR AN UNKNOWN REASON. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 682829 | EVOLUT FX VALVE | AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV | NPT | MEDTRONIC HEART VALVES DIVISION | EVOLUTFX-26 | 00763000370695 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 66 YR | Female | Required Intervention |