BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SEE H10

    MDR report key: 7488997 · Received May 4, 2018

    Report

    Report Number
    2015691-2018-01694
    Event Type
    Injury
    Date Received
    May 4, 2018
    Date of Event
    August 7, 2017
    Report Date
    April 18, 2018
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    SEE H10
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    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. 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. LATE PROSTHETIC ENDOCARDITIS IS NOT IN ANY WAY RELATED TO THE STERILIZATION OR PACKAGING PROCESS OF THE DEVICE. THE ROOT CAUSE OF THIS EVENT HAS BEEN DETERMINED TO BE DUE TO PATIENT RELATED FACTORS. THE SUBJECT DEVICE WAS NOT RETURNED FOR EVALUATION DUE TO ENDOCARDITIS. THE DEVICE HISTORY RECORD (DHR) WAS NOT REVIEWED AS THE REPORTED EVENT DOES NOT ALLEGE A MALFUNCTION THAT COULD BE RELATED TO AN EDWARDS MANUFACTURING DEFICIENCY AND/OR ONE WAS NOT CONFIRMED THROUGH INVESTIGATION. 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.

    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 THIS 21MM PERICARDIAL AORTIC VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF FOUR (4) MONTHS AND 16 DAYS DUE TO ENDOCARDITIS WITH VEGETATIONS AND FISTULA. THE FISTULA WAS IN THE RIGHT VENTRICLE-LEFT VENTRICULAR OUTFLOW TRACT (LVOT-RV). ON ECHO, THERE WAS NO EVIDENCE OF VALVE REGURGITATION, BUT LARGE VEGETATIONS WERE SEEN. THE EXPLANTED VALVE WAS REPLACED WITH A 19MM EDWARDS PERICARDIAL AORTIC VALVE. THE PATIENT DID WELL AND WAS DISCHARGED HOME. THE PATIENT WAS DOING WELL ON THE FOLLOW-UP VISITS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    330482 SEE H10 REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 2900MU21MM

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Hospitalization| R