EVOLUT PRO TRANSCATHETER AORTIC VALVE
Report
- Report Number
- 2025587-2024-01060
- Event Type
- Injury
- Date Received
- February 22, 2024
- Date of Event
- January 1, 2023
- Report Date
- March 11, 2025
- Manufacturer
- MEDTRONIC HEART VALVES DIVISION
- Product Code
- NPT
- PMA / PMN Number
- P130021
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
PRODUCT ANALYSIS: UPON RECEIPT AT MEDTRONIC¿S QUALITY LABORATORY, VISUAL INSPECTION SHOWED NO EVIDENCE OF DAMAGE OR FRACTURES ALONG THE FRAME. HOST TISSUE WAS OBSERVED ON THE FRAME AND SKIRT. ALL LEAFLETS ARE IN THE CLOSED POSITION WITH A SLIGHT GAP BETWEEN THE COAPTIVE RIDGES OF LEAFLETS 1 AND 2 ADJACENT TO THE INFERIOR COAPTIVE AREA. ALL LEAFLETS ARE SLIGHTLY STIFF BUT FLEXIBLE EXCEPT WHERE HOST TISSUE EXTENDS ON THE OUTFLOW. TWO TEARS AND ABRASIONS THROUGH THE BELLY OF LEAFLET 1 APPEARS TO BE ASSOCIATED TO POSSIBLE RESTRICTED LEAFLET MOVEMENT. THE SHINY, SMOOTH EDGES SHOW THE LEAFLET MAY HAVE HINGED AND ABRADED DUE TO HOST TISSUE OVERGROWTH ALONG THE OUTFLOW. A TEAR ON THE TUNICA OF LEAFLET 3, ADJACENT TO THE TWO ¿HOLES¿ APPEARS TO HAVE OCCURRED DURING EXPLANT. THE FREE MARGINS OF LEAFLETS 1 AND 3 APPEAR ABRADED, POSSIBLY ASSOCIATED TO THE REMOVAL OF HOST TISSUE OVERGROWTH. ALL COMMISSURES APPEAR INTACT. GL ISTENING OFF WHITE PANNUS REMAINS ATTACHED TO THE FRAME ON THE OVERALL OUTFLOW, EXTENDING TO/AND ENCAPSULATING THE L3-L2 COMMISSURAL AREA, TO THE OUTFLOW MARGINS OF ATTACHMENT (MOA) OF BOTH LEAFLET 2 AND LEAFLET 3, AND 1 TO 2.5 MM ONTO EACH CUSP. PANNUS ALONG THE OUTFLOW MARGIN OF ATTACHMENT (MOA) OF LEAFLET 1 EXTENDS 1 TO 2 MM ONTO THE CUSP, TO THE L1-L3 COMMISSURE, SLIGHTLY COVERING THE FREE MARGINS OF BOTH LEAFLETS ADJACENT TO THE COMMISSURE. REMNANTS OF PANNUS ARE NOTED ON OUTER ASPECT OF THE SKIRT. AN UNKNOWN AMOUNT OF PANNUS APPEARS TO HAVE BEEN REMOVED FROM THE OUTFLOW DURING EXPLANT. RADIOGRAPHY SHOWS EVIDENCE OF MINERALIZATION ON THE OUTER SKIRT ADJACENT TO LEAFLET 1. RADIOGRAPHY SHOWS NO EVIDENCE OF FRAME DEFORMATION OR FRACTURES. UPDATED H.6 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.
DATE IS APPROXIMATE. MONTH AND YEAR ARE CONFIRMED VALID. MEDTRONIC HAS REQUESTED ADDITIONAL INFORMATION PERTAINING TO THIS REPORTABLE EVENT. IF ADDITIONAL REPORTABLE INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. SELECT PATIENT INFORMATION CANNOT BE DOCUMENTED IN THE FILE DUE TO REGIONAL PRIVACY REGULATIONS. 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.
UPDATED DATA: H6. 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.
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.
PRODUCT ANALYSIS: UPON RECEIPT OF THE SUSPECT COMPLAINT DEVICE AT MEDTRONIC¿S QUALITY LABORATORY, VISUAL ANALYSIS SHOWED THAT THE VALVE WAS RECEIVED FULLY SUBMERGED IN CLEAR 0.2% GLUTARALDEHYDE SOLUTION IN AN EXPLANT KIT. VISUAL INSPECTION SHOWS NO EVIDENCE OF DAMAGE OR FRACTURES ALONG THE FRAME. HOST TISSUE IS OBSERVED ON THE FRAME AND SKIRT. ALL LEAFLETS ARE IN THE CLOSED POSITION WITH A SLIGHT GAP BETWEEN THE COAPTIVE RIDGES OF LEAFLETS 1 AND 2 ADJACENT TO THE INFERIOR COAPTIVE AREA. ALL LEAFLETS ARE SLIGHTLY STIFF BUT FLEXIBLE EXCEPT WHERE HOST TISSUE EXTENDS ON THE OUTFLOW. TWO TEARS AND ABRASIONS THROUGH THE BELLY OF LEAFLET 1 APPEARS TO BE ASSOCIATED TO POSSIBLE RESTRICTED LEAFLET MOVEMENT. THE SHINY, SMOOTH EDGES SHOW THE LEAFLET MAY HAVE HINGED AND ABRADED DUE TO HOST TISSUE OVERGROWTH ALONG THE OUTFLOW. ADDITIONAL TEAR ON THE TUNICA OF LEAFLET 1, ADJACENT TO THE TWO ¿HOLES¿, WAS OBSERVED. THE FREE MARGINS OF LEAFLETS 1 AND 3 APPEAR ABRADED, POSSIBLY ASSOCIATED TO THE REMOVAL OF HOST TISSUE OVERGROWTH. ALL COMMISSURES APPEAR INTACT. GLISTENING OFF WHITE PANNUS REMAINS ATTACHED TO THE FRAME ON THE OVERALL OUTFLOW, EXTENDING TO/AND ENCAPSULATING THE L3-L2 COMMISSURAL AREA, TO THE OUTFLOW MARGINS OF ATTACHMENT (MOA) OF BOTH LEAFLET 2 AND LEAFLET 3, AND 1 TO 2.5 MM ONTO EACH CUSP. PANNUS ALONG THE OUTFLOW MARGIN OF ATTACHMENT (MOA) OF LEAFLET 1 EXTENDS 1 TO 2 MM ONTO THE CUSP, TO THE L1-L3 COMMISSURE, SLIGHTLY COVERING THE FREE MARGINS OF BOTH LEAFLETS ADJACENT TO THE COMMISSURE. REMNANTS OF PANNUS ARE NOTED ON OUTER ASPECT OF THE SKIRT. AN UNKNOWN AMOUNT OF PANNUS APPEARS TO HAVE BEEN REMOVED FROM THE OUTFLOW DURING EXPLANT. RADIOGRAPHY SHOWS EVIDENCE OF MINERALIZATION ON THE OUTER SKIRT ADJACENT TO LEAFLET 2. RADIOGRAPHY SHOWS NO EVIDENCE OF FRAME DEFORMATION OR FRACTURES. THE HOLES AND TEARS APPEAR TO BE INITIATED BY ABRASION AND WEAKENING/THINNING OF THE LEAFLET MATERIAL WOULD THEN PROPAGATE TO TEARS. THE ONLY PATIENT INFORMATION PROVIDED IN THE EXPLANT REPORT WAS THE SUSPICION OF STRUCTURAL VALVE DYSFUNCTION. IN ADDITION, THE ECHO IMAGES WERE SENT TO THE INTERNAL R <(>&<)>D EXPERTS AND WERE ABLE TO CONFIRM THE LEAFLET TEAR IN THE EARLIER 10/30/2023 AND 12/1/2023 ECHO IMAGES, INDICATING THE TEAR/HOLES HAPPENED BEFORE EXPLANT. FINALLY, THE RETURNED VALVE WAS SENT FOR A HISTOLOGY EVALUATION. BASED ON THE DIAGNOSTIC INTERPRETATION, THE STRUCTURAL DETERIORATION LACKED ANY SIGNIFICANT HISTOLOGICAL CHANGES (CALCIFICATION, THROMBUS, MICROORGANISMS OR SIGNIFICATION INFLAMMATION). HOWEVER, IT WAS NOTED THAT A PERCENT OF THE MACROPHAGES PRESENT ON OR IN THE LEAFLET CONTAINED VARIABLE CYTOPLASMIC VACUOLATION AND OPTIONALLY VACANT CLEFTING WAS OCCASIONALLY PRESENT (SUGGESTIVE OF CHOLESTEROL CLEFTS), TWO HISTOLOGIC FEATURES WHICH TOGETHER WOULD BE SUGGESTIVE OF ATHEROSCLEROSIS IN A VETERINARY SPECIES. UPDATED DATA: H6. 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.
MEDTRONIC RECEIVED INFORMATION THAT 3 YEARS 3 MONTHS FOLLOWING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, SMALL VESSEL DISEASE (SVD) WAS SUSPECTED TO HAVE OCCURRED BUT THE CAUSE WAS UNKNOWN. THE PHYSICIAN SUSPECTED A LEAFLET TEAR. 4 YEARS AND 3 MONTHS FOLLOWING THE IMPLANT OF THE VALVE, SURGERY WAS SUBSEQUENTLY PERFORMED TO REPLACE THE VALVE WITH A NON-MEDTRONIC VALVE. THE VALVE WAS EXPLANTED VIA MEDIAN STERNOTOMY, AND A SUTURELESS NON-MEDTRONIC SURGICAL VALVE WAS IMPLANTED. WHEN THE TRANSCATHETER VALVE WAS REMOVED AND INSPECTED, HOLES IN 2 LOCATIONS WERE VISUALLY CONFIRMED. THE SURGERY WAS SUCCESSFUL AND THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
ADDITIONAL INFORMATION WAS RECEIVED THAT, PER THE PHYSICIAN, THE LEAFLET TEAR CONFIRMATION HAS NOT BEEN CLEARLY DETERMINED. PER THE PHYSICIAN, THE CAUSE OF THE HOLES IN THE EXPLANTED TRANSCATHETER VALVE WAS UNKNOWN. IT WAS REPORTED THAT THE TEAM RECEIVED REQUEST FROM THE PHYSICIAN THAT THEY WOULD LIKE TO KNOW THE CAUSE OF THE HOLES FROM THE INVESTIGATION. NO ADVERSE PATIENT EFFECTS WERE REPORTED.
CORRECTED INFORMATION WAS RECEIVED WHICH CORRECTED SMALL VESSEL DISEASE (SVD) TO STRUCTURAL VALVE DYSFUNCTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1642830 | EVOLUT PRO TRANSCATHETER AORTIC VALVE | AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV | NPT | MEDTRONIC HEART VALVES DIVISION | EVOLUTPRO-26 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention| H |