EVOLUT PRO PLUS VALVE
Report
- Report Number
- 2025587-2023-01271
- Event Type
- Injury
- Date Received
- March 30, 2023
- Date of Event
- November 30, 2022
- Report Date
- June 8, 2023
- Manufacturer
- MEDTRONIC HEART VALVES DIVISION
- Product Code
- NPT
- UDI-DI
- 00763000211110
- PMA / PMN Number
- P130021
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
CONCLUSION: IMAGES WERE SUBMITTED TO MEDTRONIC FOR REVIEW. INTRA PROCEDURAL ANGIOGRAM IMAGES WERE PROVIDED FOR REVIEW OF THE EVENT D ESCRIPTION ABOVE. PATIENT¿S EXECUTIVE SUMMARY WAS NOT PROVIDED FOR ANATOMICAL REVIEW. FLUOROSCOPY VALVE LOAD INSPECTION WAS PERFORMED AND CONFIRMED A GOOD LOAD. DEPTH ASSESSMENT IN THE CUSP OVERLAP VIEW APPEARS TO BE LESS THAN 1MM AT THE NON-CORONARY CUSP (NCC). DEPTH ASSESSMENT IN THE LAO VIEW APPEARS TO BE APPROXIMATELY 2MM AT THE LEFT CORONARY CUSP (LCC). MEDTRONIC RECOMMENDS A TARGET DEPTH OF 3MM. RECAPTURE IS RECOMMENDED IF DEPTH <(><<)>1MM OR >5MM. IN THIS CASE, A RECAPTURE WAS WARRANTED. HOWEVER, THE IMPLANTING TEAM RELEASED THE VALVE WHICH ENDED UP DISLODGING INTO THE SINUSES. SUBSEQUENTLY, A NON-MEDTRONIC VALVE WAS IMPLANTED. THE REPORTED EVENT INDICATES THAT DURING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, AT 80% DEPLOYMENT, THE VALVE WAS POS ITIONED AT 1 MILLIMETER (MM) ON THE NON-CORONARY CUSP (NCC) AND 2MM ON THE LEFT CORONARY CUSP (LCC). THE PHYSICIAN DETERMINED THAT THE DEPTH WAS ACCEPTABLE AND FULLY DEPLOYED THE VALVE. SUBSEQUENTLY, THE VALVE DISLODGED INTO THE SINUSES. POTENTIAL FACTORS THAT CAN INFLUENCE A DISLODGED VALVE INCLUDE TENSION APPLIED ON THE DCS DURING POSITIONING, CALCIFICATION LEVELS IN THE NATIVE VESSEL, COMPLIANCE OF THE AORTA AND NATIVE VESSELS, AND A NUMBER OF OTHERS. BASED ON THE IMAGE REVIEW, DEPTH ASSESSMENT IN THE CUSP OVERLAP VIEW APPEARS TO BE LESS THAN 1MM AT THE NCC AND RECAPTURE IS RECOMMENDED IF DEPTH <(><<)>1MM OR >5MM. IN THIS CASE, A RECAPTURE WAS WARRANTED. HOWEVER, THE IMPLANTING TEAM RELEASED THE VALVE WHICH ENDED UP DISLODGING INTO THE SINUSES. DISLODGE EVENTS ARE TYPICALLY NOT RELATED TO A DEVICE MALFUNCTION. 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: 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.
PRODUCT ANALYSIS: THE DEVICE REMAINS IMPLANTED, THEREFORE NO PRODUCT ANALYSIS CAN BE PERFORMED. CONCLUSION: WITHOUT THE RETURN OF THE PRODUCT, NO DEFINITIVE CONCLUSION CAN BE MADE REGARDING THE CLINICAL OBSERVATION. 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 INDICATING THAT NO PRE-IMPLANT BALLOON AORTIC VALVULOPLASTY (BAV) WAS PERFORMED.
MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, AT 80% DEPLOYMENT, THE VALVE WAS POSITIONED AT 1 MILLIMETER (MM) ON THE NON-CORONARY CUSP (NCC) AND 2MM ON THE LEFT CORONARY CUSP (LCC). THE PHYSICIAN DETERMINED THAT THE DEPTH WAS ACCEPTABLE AND FULLY DEPLOYED THE VALVE. SUBSEQUENTLY, THE VALVE DISLODGED INTO THE SINUSES. A NON-MEDTRONIC VALVE WAS IMPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 211290 | EVOLUT PRO PLUS VALVE | AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV | NPT | MEDTRONIC HEART VALVES DIVISION | EVPROPLUS-26US | 00763000211110 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 88 YR | Male | Required Intervention |