BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SEE H10

    MDR report key: 9997042 · Received April 24, 2020

    Report

    Report Number
    2015691-2020-11686
    Event Type
    Injury
    Date Received
    April 24, 2020
    Date of Event
    January 11, 2020
    Report Date
    March 31, 2020
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    SEE H10
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED TO EDWARDS FOR EVALUATION DUE TO ENDOCARDITIS. PROSTHETIC ENDOCARDITIS WITH OR WITHOUT VEGETATION, OF VALVES AND ANNULOPLASTY RINGS IS A SERIOUS COMPLICATION OF VALVE REPLACEMENT AND VALVE REPAIR SURGERIES DESPITE IMPROVEMENTS IN PROSTHESES TYPES, SURGICAL TECHNIQUES, AND INFECTION CONTROL MEASURES. THIS INFECTION IS GENERALLY CATEGORIZED INTO EARLY (ONSET USUALLY LESS THAN 60 DAYS POSTOPERATIVE) AND LATE (ONSET GREATER THAN 60 DAYS POST-IMPLANTATION). LATE PROSTHETIC ENDOCARDITIS RESEMBLES NATIVE VALVE ENDOCARDITIS IN TERMS OF ETIOLOGICAL MICROBES, AND SOURCES OF CONTAMINATION ARE PRESUMABLY SIMILAR. LATE ENDOCARDITIS OCCURS DUE TO THE IMPLANT BEING SEEDED FROM AN INFECTION OR MICROBIAL CONTAMINATION FROM ELSEWHERE IN THE BODY. DENTAL, GENITOURINARY, AND GASTROINTESTINAL MANIPULATION ARE KNOWN CAUSES OF TRANSIENT BACTEREMIA, WHICH CAN PLACE A PATIENT AT RISK FOR PROSTHETIC ENDOCARDITIS. ADDITIONAL PROCEDURES PLACING PATIENTS AT RISK FOR PROSTHETIC ENDOCARDITIS INCLUDE URETHRAL CATHETERIZATION, COLONOSCOPY, BARIUM ENEMAS, AND SURGICAL PROCEDURES. THE CAUSE OF THE EVENT CANNOT CONCLUSIVELY BE DETERMINED; HOWEVER, PATIENT FACTORS LIKELY CONTRIBUTED TO THE EVENT.

    Description of Event or Problem · 0

    EDWARDS RECEIVED INFORMATION A 25MM AORTIC PERICARDIAL VALVE WAS EXPLANTED AFTER 4 YEARS, 2 MONTHS, DUE TO ENDOCARDITIS. MICROORGANISM WAS STAPHYLOCOCCUS EPIDERMIS AND THE SURGEON STATED THAT THE ROOT CAUSE FOR THE ENDOCARDITIS WAS PROBABLY A SKIN LESION ON THE CHEST NEAR THE INCISION SITE. A 25MM AORTIC VALVE WAS IMPLANTED IN REPLACEMENT. PATIENT HAD TO BE REOPEN DUE TO TAMPONADE. PATIENT WAS DISCHARGED HOME AND AS PER THE LAST FOLLOW-UP VISIT WAS DOING VERY WELL.

    Additional Manufacturer Narrative · 1

    THIS MODEL IS NOT SOLD OR MARKETED IN THE U.S. HOWEVER, IT IS SIMILAR TO DEVICE: MODEL #2800; BRAND NAME: CARPENTIER-EDWARDS PERIMOUNT RSR PERICARDIAL BIOPROSTHESIS; PMA #P860057/S001. IN THIS CASE, MINIMAL INFORMATION REGARDING THIS REDO-AVR PROCEDURE WAS RECEIVED AND ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE CONDITION OF THE DEVICE, PATIENT'S MEDICAL HISTORY, OR POSSIBLE COMORBIDITIES HAVE BEEN MADE. THE ROOT CAUSE OF THIS EVENT CANNOT BE DETERMINED WITH THE AVAILABLE INFORMATION. THE DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED AND THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS PRIOR TO RELEASE FOR DISTRIBUTION. THERE WERE NO ISSUES IDENTIFIED THAT WOULD HAVE IMPACTED THIS EVENT. EDWARDS WILL CONTINUE TO REVIEW AND MONITOR ALL EVENTS. TRENDS ARE MONITORED ON A MONTHLY BASIS AND IF ACTION IS REQUIRED, APPROPRIATE INVESTIGATION WILL BE PERFORMED. IF NEW INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    EDWARDS LIFESCIENCES MAINTAINS AN IMPLANT PATIENT REGISTRY. THIS REGISTRY IS A PATIENT TRACKING MECHANISM FOR SERIALIZED EDWARDS IMPLANTABLE DEVICES (BIOPROSTHETIC HEART VALVES AND ANNULOPLASTY RINGS), RATHER THAN A TRUE POST-MARKET SURVEILLANCE REGISTRY. THROUGH THE REGISTRY, EDWARDS IS NOTIFIED WHEN THESE DEVICES ARE IMPLANTED. IN ADDITION, PATIENT AND/OR DEVICE STATUS MAY BE REPORTED TO THE REGISTRY VIA THE IMPLANTATION DATA CARDS. THE INFORMATION IS RECEIVED FROM VARIOUS SOURCES (E.G. SURGEON, HOSPITAL, AND PATIENT FAMILY MEMBERS) AND IS NOT RECEIVED IN THE FORM OF A CONVENTIONAL "CUSTOMER COMPLAINT". THE INFORMATION REPORTED MAY OR MAY NOT BE RELATED TO THE EDWARDS DEVICE. IT WAS REPORTED THAT A 25MM 2900 AORTIC PERICARDIAL VALVE WAS EXPLANTED FROM THE AORTIC POSITION AFTER AN IMPLANT DURATION OF FOUR (4) YEARS AND TWO (2) MONTHS DUE TO UNKNOWN REASON. ANOTHER 25MM 2900 AORTIC VALVE WAS IMPLANTED IN REPLACEMENT. NO OTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    457828 SEE H10 REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 290025MM

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Hospitalization| L| R