SEE H10
Report
- Report Number
- 2015691-2024-00021
- Event Type
- Injury
- Date Received
- January 3, 2024
- Date of Event
- April 1, 2019
- Report Date
- February 6, 2024
- Manufacturer
- EDWARDS LIFESCIENCES
- Product Code
- DYE
- PMA / PMN Number
- SEE H10
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
H10: ADDITIONAL MANUFACTURER NARRATIVE THIS IS ONE OF TWO MANUFACTURER REPORTS BEING SUBMITTED FOR THIS ARTICLE. REFER TO MEDWATCH NUMBER 41204 FOR ADDITIONAL EVENT WITHIN THE SAME ARTICLE. THIS DEVICE IS NOT SOLD OR MARKETED IN THE UNITED STATES. HOWEVER, IT IS SIMILAR TO DEVICE MODEL # 6625LP, PMA# P870077, BRAND NAME CARPENTIER-EDWARDS DURAFLEX LOW PRESSURE MITRAL BIOPROSTHESIS. THE SUBJECT DEVICE IS NOT AVAILABLE FOR EVALUATION AS IT REMAINS IMPLANTED IN THE PATIENT. THE DATE OF THE EVENTS ARE UNKNOWN; HOWEVER, ACCORDING TO THE ARTICLE, THE STUDY PERIOD WAS FROM APRIL 2019 TO SEPTEMBER 2021. THUS, THE FIRST DAY OF THE REPORTED STUDY PERIOD (1 APR 2019) WAS USED AS THE DATE OF EVENT. ARTICLE CITATION: LIU L, XIAO B, WU B AND GUO Y (2022) TRANSCATHETER MITRAL VALVE-IN-VALVE IMPLANTATIONS USING INVERTED J-VALVE. FRONT. CARDIOVASC. MED. 9:896639. DOI: (B)(4).THE INVESTIGATION IS STILL IN PROGRESS; THEREFORE, A CONCLUSION HAS YET TO BE ESTABLISHED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY UPON INVESTIGATION COMPLETION. EDWARDS WILL CONTINUE TO REVIEW AND MONITOR ALL REPORTED EVENTS. TRENDS ARE MONITORED ON A MONTHLY BASIS AND IF ACTION IS REQUIRED, APPROPRIATE INVESTIGATION WILL BE PERFORMED.
ADDITIONAL MANUFACTURER NARRATIVE: THE DEVICE WAS NOT RETURNED FOR EVALUATION AS IT REMAINED IMPLANTED AFTER THE VALVE-IN-VALVE (VIV) PROCEDURE, THEREFORE CUSTOMER REPORT OF STRUCTURAL VALVE DETERIORATION COULD NOT BE CONFIRMED BY PRODUCT EVALUATION. TISSUE DEGENERATION-RELATED STRUCTURAL DETERIORATION, EITHER CALCIFIC OR NON-CALCIFIC, ARE COMMON CHRONIC FAILURE MODES FOR THIS TYPE OF BIOPROSTHETIC HEART VALVE. OPERATIONAL MECHANICAL STRESS AND BIOLOGICAL FACTORS ARE GENERALLY BELIEVED TO BE THE MAJOR CONTRIBUTORS TO THE NON-CALCIFIC BIOPROSTHETIC TISSUE DEGENERATION. STRUCTURAL VALVE DETERIORATION (SVD) CAN, AND TYPICALLY DOES, LEAD TO CHRONIC CENTRAL LEAKS OVER A PERIOD OF TIME. SVD IS THE MOST COMMON REASON FOR BIOPROSTHESIS EXPLANT AND ENCOMPASSES MULTIPLE FAILURE MODES, INCLUDING CALCIFICATION, NON-CALCIFIC DEGENERATION, DEHISCENCE, CUSP THICKENING OR FIBROSIS, OR A COMBINATION OF THESE. SUCH FAILURE MODES MAY OCCUR SINGULARLY OR CONCOMITANTLY. DEGENERATION-RELATED STRUCTURAL DETERIORATION IS MOST COMMONLY RELATED TO PATIENT FACTORS AND IS NOT USUALLY AN INDICATION OF A DEVICE MALFUNCTION RELATED TO A MANUFACTURING DEFICIENCY. THE INSTRUCTIONS FOR USE (IFU) HAVE BEEN REVIEWED AND NO INADEQUACIES HAVE BEEN IDENTIFIED WITH REGARD TO WARNINGS, CONTRAINDICATIONS, AND THE DIRECTIONS/CONDITIONS FOR THE SUCCESSFUL USE OF THE DEVICE. THE REPORTED TYPE OF EVENT IS INCLUDED IN THE IFU. A DEFINITIVE ROOT CAUSE CANNOT BE CONCLUSIVELY DETERMINED; HOWEVER, PATIENT FACTORS LIKELY CAUSED OR CONTRIBUTED.
THROUGH REVIEW OF MEDICAL ARTICLE "TRANSCATHETER MITRAL VALVE-IN-VALVE REPLACEMENT IMPLANTATIONS USING INVERTED J-VALVE" , THE FOLLOWING EVENTS WERE IDENTIFIED AS PERTAINING TO EDWARDS DEVICES: ONE PATIENT WITH A CARPENTIER-EDWARDS SAV VALVE MODEL 6650 IMPLANTED IN MITRAL POSITION UNDERWENT VALVE-IN-VALVE PROCEDURE AFTER AN UNKNOWN IMPLANT DURATION DUE TO STRUCTURAL VALVE DEGENERATION. A NON-EDWARDS TRANSCATHETER VALVE WAS SUCCESSFULLY IMPLANTED WITHIN THE SURGICAL VALVE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1549458 | SEE H10 | REPLACEMENT HEART-VALVE | DYE | EDWARDS LIFESCIENCES | 2650 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Hospitalization| L| R |