BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SEE H10

    MDR report key: 6963655 · Received October 19, 2017

    Report

    Report Number
    2015691-2017-03470
    Event Type
    Injury
    Date Received
    October 19, 2017
    Date of Event
    September 8, 2017
    Report Date
    September 27, 2017
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    SEE H10
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED AND THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS PRIOR TO RELEASE FOR DISTRIBUTION.

    Additional Manufacturer Narrative · 1

    THE REASON FOR EXPLANTING THE SUBJECT DEVICE WAS NOT PROVIDED BY THE HEALTHCARE PROVIDER. THE EXPLANTED VALVE HAS ALSO NOT BEEN RETURNED FOR EVALUATION. THERE IS CURRENTLY INSUFFICIENT INFORMATION AVAILABLE TO DETERMINE THE ROOT CAUSE OF THIS EVENT. HOWEVER, THERE HAS BEEN NO ALLEGATION OF ANY DEVICE MALFUNCTION. THE IFU WAS REVIEWED AND NO INADEQUACIES WERE IDENTIFIED WITH REGARDS TO WARNINGS, CONTRAINDICATIONS, AND THE DIRECTIONS/CONDITIONS FOR THE SUCCESSFUL USE OF THE DEVICE. NO CORRECTIVE ACTIONS ARE REQUIRED BASED ON THIS EVENT. 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. IF ANY NEW INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY. OF NOTE, 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.

    Additional Manufacturer Narrative · 1

    IT WAS LEARNED THAT THE ENDOCARDITIS WAS DIAGNOSED FOUR (4) MONTHS AND 22 DAYS AFTER THE IMPLANT. THERE WERE NO UNDERLYING PRECIPITATION FACTOR THAT MY HAVE CONTRIBUTED TO THE DEVELOPMENT OF THIS 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. 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. THERE HAS BEEN NO ALLEGATION OF A DEVICE MALFUNCTION OR DEFICIENCY. EDWARDS WILL CONTINUE TO REVIEW OF ALL REPORTED EVENTS AND PERFORM TREND ANALYSIS ON A MONTHLY BASIS. IF ACTION IS REQUIRED, APPROPRIATE INVESTIGATION WILL BE PERFORMED.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA THE IMPLANT PATIENT REGISTRY THAT AN AORTIC VALVE WAS EXPLANTED DUE TO ENDOCARDITIS LEADING TO VEGETATIONS AND LEAFLET HOLE AFTER AN IMPLANT DURATION OF NINE (9) MONTHS AND FOUR (4) DAYS. AS REPORTED, THE VALVE WAS SENT TO THE HOSPITAL LABORATORY AND THEY FOUND THE ORGANISM ENTEROCCOCUS FAECALIS. THE VALVE WAS EXPLANTED AND ANOTHER EDWARDS VALVE SAME MODEL AND SIZE WAS IMPLANTED IN REPLACEMENT. THE PATIENT WAS DISCHARGED HOME.

    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. IN THIS CASE, IT WAS REPORTED THAT A BIOPROSTHETIC AORTIC VALVE WAS EXPLANTED FROM A (B)(6)-Y-O LADY AFTER AN IMPLANT DURATION OF NINE (9) MONTHS AND FOUR (4) DAYS FOR UNKNOWN REASONS. ANOTHER EDWARDS VALVE OF THE SAME MODEL AND SIZE WAS IMPLANTED IN REPLACEMENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    742766 SEE H10 REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 2900

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Hospitalization| R