MEDTRONIC TRANSCATHETER VALVE
Report
- Report Number
- 2025587-2023-03986
- Event Type
- Death
- Date Received
- October 3, 2023
- Date of Event
- June 5, 2023
- Report Date
- October 3, 2023
- 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: WIENEMANN H, MAIER O, BEYER M, ET AL. CUSP OVERLAP VERSUS STANDARD THREE-CUSP TECHNIQUE FOR SELF-EXPANDING EVOLUT TRANSCATHETER AORTIC VALVES. EUROINTERVENTION. 2023;19(2):E176-E187. PUBLISHED 2023 JUN 5. DOI:10.4244/EIJ-D-22-01030. EARLIEST DATE OF PUBLICATION USED FOR DATE OF EVENT AND DATE OF DEATH. MEDTRONIC PRODUCTS REFERENCED: EVOLUT R (PRODUCT CODE NPT, PMA# P130021), EVOLUT PRO (PRODUCT CODE NPT, PMA# P130021), EVOLUT PRO+ ( PRODUCT CODE NPT, PMA# P130021). EARLIEST APPROVED PRODUCT USED FOR PRODUCT CODE AND PMA#. 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. 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.
LITERATURE WAS REVIEWED REGARDING THE CUSP-OVERLAP TECHNIQUE COMPARED TO THE STANDARD THREE-CUSP IMPLANTATION TECHNIQUE DURING TRANSCATHETER AORTIC VALVE IMPLANTATION (TAVI). A TOTAL OF 2,209 PATIENTS WHO UNDERWENT TAVI WITH THE MEDTRONIC EVOLUT PLATFORM (EVOLUT R, PRO, OR PRO+) WERE INCLUDED IN THE STUDY. DURING TAVI, THE CUSP-OVERLAP TECHNIQUE WAS USED IN 1,058 CASES AND THE STANDARD THREE-CUSP TECHNIQUE WAS UTILIZED IN 1,151 CASES. THE AUTHORS OBSERVED 30 IN-HOSPITAL DEATHS. THE CIRCUMSTANCES OF THE DEATHS WERE NOT DISCLOSED. OTHER ADVERSE EVENTS THAT OCCURRED WERE DESCRIBED AS FOLLOWS: NEW PERMANENT PACEMAKER IMPLANTATION; NEW LEFT OR RIGHT BUNDLE BRANCH BLOCK; BLEEDING (MINOR, MAJOR, OR LIFE-THREATENING); VASCULAR COMPLICATION (MINOR OR MAJOR); ACUTE KIDNEY INJURY (STAGE 1, 2, OR 3); NEW STROKE; CONVERSION TO OPEN SURGERY; VALVE MIGRATION/EMBOLIZATION; VALVE MALPOSITION; NEED FOR SECOND VALVE IMPLANTATION; MEAN AORTIC VALVE GRADIENT (=20 MMHG); AND PARAVALVULAR REGURGITATION (MILD, MODERATE, OR SEVERE). NO ADDITIONAL ADVERSE EVENTS WERE NOTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 589107 | MEDTRONIC TRANSCATHETER VALVE | AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV | NPT | MEDTRONIC HEART VALVES DIVISION | MDT-TRANS VALVE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 82 YR | Female | Death |