EDWARDS THV VALVE UNKNOWN
Report
- Report Number
- 2015691-2021-06162
- Event Type
- Injury
- Date Received
- November 7, 2021
- Report Date
- November 8, 2021
- Manufacturer
- EDWARDS LIFESCIENCES
- Product Code
- NPU
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
PLEASE REFERENCE RELATED MANUFACTURER REPORT NOS: 2015691-2021-06170 AND 2015691-2021-06176.
THIS IS ONE OF THREE MANUFACTURER REPORTS BEING SUBMITTED FOR THIS CASE. CITATION: MOHAMED, TAHIR I., ET AL. ''TRANSCATHETER MITRAL VALVE-IN-VALVE IMPLANTATION FOR FAILED BIOPROSTHESIS.'' TURK KARDIYOL DERN ARS 49.1 (2021): 22-28. THE IMPLANTED VALVE MODEL AND SIZE IS UNKNOWN. POSSIBLE VALVE USED - EDWARDS SAPIEN TRANSCATHETER HEART VALVE - PMA P110021, EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE - PMA P130009, OR EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE - PMA P140031. PER THE INSTRUCTIONS FOR USE (IFU), INFECTION INCLUDING SEPTICEMIA AND ENDOCARDITIS, IS A POTENTIAL ADVERSE EVENT ASSOCIATED WITH VALVE REPLACEMENT. ENDOCARDITIS IS AN INFECTION OF A NATIVE OR PROSTHETIC VALVE, IS TREATED WITH ANTIBIOTICS, AND MAY REQUIRE VALVE REPLACEMENT IF ANTIBIOTIC THERAPY IS NOT EFFECTIVE. CAUSES OF PROSTHETIC VALVE ENDOCARDITIS ARE WELL DOCUMENTED IN THE LITERATURE AND ARE TYPICALLY CLASSIFIED AS EARLY (<60 DAYS) OR LATE (>60 DAYS). EARLY PROSTHETIC VALVE ENDOCARDITIS IS USUALLY CAUSED BY PERIOPERATIVE BACTERIAL CONTAMINATION OF THE VALVE. EDWARDS LIFESCIENCES PRODUCES AND PROVIDES STERILE TISSUE BIOPROSTHESES TO ITS CUSTOMERS BY FOLLOWING CAREFULLY DESIGNED ROBUST STERILIZATION PROCESSES. THESE MANUFACTURING PROCESSES HAVE BEEN VALIDATED AND DEMONSTRATED TO CONSISTENTLY PROVIDE A SIGNIFICANT SAFETY FACTOR FROM WHICH MICROORGANISMS COULD NOT SURVIVE. MICROBIOLOGY AND PROCESS MONITORING IS ROUTINELY REVIEWED WITHIN QUALITY SYSTEMS TO MAINTAIN STERILITY CONTROL. VALIDATED TESTING HAS DEMONSTRATED THAT MICROORGANISMS COULD NOT SURVIVE EDWARDS' MULTI-STAGE PROCESSING WITH ENHANCED STERILANT OR HEATED GLUTARALDEHYDE TERMINAL STERILANT SOLUTION. THESE MULTIPLE, REDUNDANT MANUFACTURING CONTROLS ENSURE THE STERILITY OF EDWARDS' VALVES AS PROVIDED TO CUSTOMERS. THEREFORE THE PROBABILITY OF ENDOCARDITIS RELATED TO EDWARDS' BIOPROSTHESES IS REMOTE. IN THIS CASE, THERE WAS NO ALLEGATION OR INDICATION OF A DEVICE MALFUNCTION. WITH THE LIMITED INFORMATION PROVIDED, THE TYPE OF BACTERIA CAUSING THE BACTERIA ALONG WITH THE SOURCE OF THE INFECTION ARE UNKNOWN. ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFORMATION, BUT TO DATE, NO ADDITIONAL DETAILS HAVE BEEN RECEIVED. THE IFU AND TRAINING MANUALS HAVE BEEN REVIEWED AND NO INADEQUACIES HAVE BEEN IDENTIFIED WITH REGARDS TO WARNINGS, CONTRAINDICATIONS, AND THE DIRECTIONS/CONDITIONS FOR THE SUCCESSFUL USE OF THE DEVICE. COMPLAINT HISTORIES FOR ALL REPORTED EVENTS ARE REVIEWED AGAINST TRENDING CONTROL LIMITS ON A MONTHLY BASIS, AND ANY EXCURSIONS ABOVE THE CONTROL LIMITS ARE ASSESSED AND DOCUMENTED AS PART OF THIS MONTHLY REVIEW. NO CORRECTIVE OR PREVENTATIVE ACTIONS ARE REQUIRED AT THIS TIME.
AS REPORTED BY THE EDWARDS SAUDI ARABIAN AFFILIATE, REVIEW OF THE MEDICAL ARTICLE, ''TRANSCATHETER MITRAL VALVE-IN-VALVE IMPLANTATION FOR FAILED BIOPROSTHESIS'' WAS PERFORMED. AFTER TRANSAPICAL TRANSCATHETER MITRAL VIV IMPLANTATION FOR A FAILED BIOPROSTHESIS WITH A SAPIEN, SAPIEN XT OR A SAPIEN 3 VALVE ONE PATIENT PRESENTED WITH ENDOCARDITIS PRIOR TO DISCHARGE, WHICH RESOLVED COMPLETELY AFTER 1 WEEK OF INTRAVENOUS ANTIBIOTICS. THE SOURCE OF THE INFECTION IS UNKNOWN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1661565 | EDWARDS THV VALVE UNKNOWN | PROSTHESIS, MITRAL VALVE, PERCUTANEOUSLY DELIVERED | NPU | EDWARDS LIFESCIENCES | EDWARDS THV VALVE UNKNOWN | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Required Intervention |