COREVALVE TRANSCATHETER AORTIC VALVE
Report
- Report Number
- 2025587-2021-03821
- Event Type
- Injury
- Date Received
- December 22, 2021
- Date of Event
- November 26, 2021
- Report Date
- December 23, 2021
- Manufacturer
- MEDTRONIC HEART VALVES DIVISION
- Product Code
- NPT
- PMA / PMN Number
- P130021
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
CITATION: PIAYDA ET AL. PROCEDURAL RESULTS OF PATIENTS UNDERGOING TRANSCATHETER AORTIC VALVE IMPLANTATION WITH AORTIC ANNULI DIAMETER =26 MM: INSIGHTS FROM THE GERMAN AORTIC VALVE REGISTRY. AM J CARDIOL. 2021 NOV 26;S0002-9149(21)01046-8. DOI: 10.1016/J.AMJCARD.2021.10.021. EARLIEST DATE OF PUBLISH USED FOR DATE OF EVENT. NO UNIQUE DEVICE IDENTIFIER (SERIAL/LOT) NUMBERS WERE PROVIDED; WITHOUT THIS INFORMATION IT COULD NOT BE DETERMINED WHETHER THESE OBSERVATIONS HAVE BEEN PREVIOUSLY REPORTED. WITHOUT RETURN OF THE PRODUCT NO DEFINITIVE CONCLUSION CAN BE MADE REGARDING THE CLINICAL OBSERVATIONS. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
CORRECTION TO MANUFACTURER'S AWARE DATE IN G3. NEW INFORMATION RECEIVED FROM PHYSICIAN/AUTHOR ON DECEMBER 23, 2021. THEREFORE DATE CHANGED FROM 2021.12.08 TO 2021.12.23. 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.
MEDTRONIC RECEIVED INFORMATION VIA LITERATURE REGARDING RESULTS OF PATIENTS UNDERGOING TRANSCATHETER AORTIC VALVE IMPLANTATION (TAVI) WITH AORTIC ANNULI DIAMETER GREATER THAN 25 MM. ALL DATA WERE COLLECTED FROM THE GERMAN AORTIC VALVE REGISTRY DATABASE FROM JANUARY 2011 TO DECEMBER 2017. THE STUDY POPULATION INCLUDED 509 PATIENTS (PREDOMINANTLY MALE, MEAN AGE 80.4 YEARS). MULTIPLE MANUFACTURER¿S DEVICES WERE IMPLANTED IN THE STUDY POPULATION. AMONG ALL PATIENTS 198 WERE IMPLANTED WITH A MEDTRONIC COREVALVE BIOPROSTHETIC VALVE (UNIQUE DEVICE IDENTIFIER NUMBERS NOT PROVIDED). AMONG ALL PATIENTS, THE 30-DAY MORTALITY WAS 3.9% IN THE LARGE AORTIC DIAMETER GROUP AND 5.0% IN THE EXTRA-LARGE AORTIC DIAMETER GROUP. NO FURTHER DETAILS WERE PROVIDED ON THE DEATHS. BASED ON THE AVAILABLE INFORMATION MEDTRONIC PRODUCT WAS NOT DIRECTLY ASSOCIATED WITH THE DEATH(S). AMONG ALL PATIENTS, ADVERSE EVENTS INCLUDED: PERICARDIAL TAMPONADE, MYOCARDIAL INFARCTION (MI), AND MODERATE TO SEVERE AORTIC REGURGITATION (AR, PARAVALVULAR LEAK (PVL), VASCULAR COMPLICATIONS, ARRHYTHMIA REQUIRING PERMANENT PACEMAKER IMPLANT, STROKE, AND CONVERSION TO SURGERY OR VALVE-IN-VALVE INTERVENTIONS. BASED ON THE AVAILABLE INFORMATION MEDTRONIC PRODUCT MAY HAVE BEEN ASSOCIATED WITH THE ADVERSE EVENT(S). NO ADDITIONAL ADVERSE PATIENT EFFECTS OR PRODUCT PERFORMANCE ISSUES WERE REPORTED.
ADDITIONAL INFORMATION RECEIVED FROM THE PHYSICIAN/AUTHOR STATED: 1) THE RELATIONSHIP BETWEEN MEDTRONIC PRODUCT AND THE OBSERVED DEATHS AND/OR ADVERSE EVENTS COULD NOT BE VERIFIED DUE TO NATURE OF THE SOURCE DATA FOR THE STUDY, 2) NO UNIQUE DEVICE IDENTIFIERS WERE AVAILABLE, AND 3) NO EXPLANTED DEVICES WERE AVAILABLE FOR PHYSICAL ANALYSIS.
ADDITIONAL INFORMATION RECEIVED FROM THE PHYSICIAN/AUTHOR STATED: 1) THE RELATIONSHIP BETWEEN MEDTRONIC PRODUCT AND THE OBSERVED DEATHS AND/OR ADVERSE EVENTS COULD NOT BE VERIFIED DUE TO NATURE OF THE SOURCE DATA FOR THE STUDY, 2) NO UNIQUE DEVICE IDENTIFIERS WERE AVAILABLE, AND 3) NO EXPLANTED DEVICES WERE AVAILABLE FOR PHYSICAL ANALYSIS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1964716 | COREVALVE TRANSCATHETER AORTIC VALVE | AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV | NPT | MEDTRONIC HEART VALVES DIVISION | CRS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 80 YR | Male | Life Threatening| R| H |