BEUDAMED
    FDA Adverse Event Death Summary report: N

    COREVALVE

    MDR report key: 4223049 · Received November 4, 2014

    Report

    Report Number
    2025587-2014-00832
    Event Type
    Death
    Date Received
    November 4, 2014
    Date of Event
    June 26, 2014
    Report Date
    June 2, 2015
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM THE CLINICAL STUDY SITE. THE PRODUCT REMAINS IMPLANTED AND THEREFORE HAS NOT BEEN RETURNED TO MEDTRONIC. A SUPPLEMENTAL REPORT WILL BE FILED WHEN THE INVESTIGATION IS COMPLETED. (B)(4).

    Additional Manufacturer Narrative · 1

    THE DEATH CERTIFICATE PROVIDED BY THE FUNERAL HOME TO THE HOSPITAL LISTED THE IMMEDIATE CAUSE OF DEATH AS MRSA BACTEREMIA/SEPSIS, DUE TO OR AS A CONSEQUENCE OF PROBABLE ENDOCARDITIS, DUE TO OR AS A CONSEQUENCE OF AORTIC VALVE REPLACEMENT. THE DEATH CERTIFICATE ALSO NOTED THAT ALZHEIMER'S DEMENTIA AND CHRONIC KIDNEY DISEASE WERE CONTRIBUTING FACTORS. IT WAS REPORTED THAT THE CLINICAL STUDY SITE SUBSEQUENTLY RECLASSIFIED THE RELATIONSHIP BETWEEN THE DEVICE/IMPLANT PROCEDURE AND THE SEPSIS/ENDOCARDITIS FROM PROBABLE/POSSIBLE TO REMOTE.

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD WAS REVIEWED AND SHOWED THAT THIS PRODUCT MET ALL MANUFACTURING SPECIFICATIONS FOR PRODUCT RELEASED FOR DISTRIBUTION. NO ISSUES WERE IDENTIFIED THAT WOULD HAVE IMPACTED THIS EVENT.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    CONCLUSION: THE STERILIZATION PROCESS USED BY MEDTRONIC HAS AN ANTI-MICROBIAL KILL ON MICROORGANISMS SUCH AS STAPHYLOCOCCUS AND STREPTOCOCCUS SPECIES. IN ADDITION, THE OCCURRENCE OF ENDOCARDITIS WAS 8 MONTHS POST IMPLANT. BASED ON THE DESCRIPTIVE COMMENTS OUTLINED FROM THE JOURNAL LITERATURE, ENDOCARDITIS CASES OCCURRING BETWEEN 2 AND 12 MONTHS POST IMPLANT ARE KNOWN TO BE A MIXTURE OF COMMUNITY-ACQUIRED EPISODES AND HOSPITAL-ACQUIRED EPISODES CAUSED BY LESS VIRULENT ORGANISMS. THESE CASES MAY ALSO BE DUE TO INTRODUCTION OF THE MICROORGANISM DURING THE IMPLANT PROCEDURE. REFER TO THE ARTICLE REFERENCED BELOW. THEREFORE, IT IS UNLIKELY THAT THE ENDOCARDITIS ORIGINALLY CAME FROM THE DEVICE AND/OR MANUFACTURING VALVE PROCESS. WITHOUT THE RETURN OF THE VALVE, A ROOT CAUSE FOR THE CLINICAL OBSERVATION WAS UNABLE TO BE DETERMINED. MYLONAKIS, E., AND CALDERWOOD, S.B. INFECTIVE ENDOCARDITIS IN ADULTS. NEW ENGLAND JOURNAL OF MEDICINE. 345 (18). 1318-1330. NOV.1, 2001.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION THAT APPROXIMATELY SEVEN MONTHS AFTER THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE THE PATIENT WAS ADMITTED TO A HOSPITAL AFTER SUSTAINING A FALL. THERE WAS NO EVIDENCE OF A FRACTURE, AND THE PATIENT WAS DIAGNOSED WITH A RIGHT HIP CONTUSION AND HIP STRAIN. THE PATIENT WAS TREATED WITH PHYSICAL THERAPY AND PAIN MANAGEMENT, AND DISCHARGED TO A SKILLED NURSING FACILITY. TWO DAYS LATER, THE PATIENT DEVELOPED SEPSIS/MRSA BACTEREMIA OF AN UNKNOWN SOURCE AND ACUTE ON CHRONIC RENAL FAILURE. THE PATIENT WAS TRANSFERRED TO ACUTE CARE AT ANOTHER MEDICAL FACILITY AND TREATED FOR PRESUMED ENDOCARDITIS. THE PATIENT DID NOT EXHIBIT IMPROVEMENT, AND APPROXIMATELY TWO WEEKS LATER HIS FAMILY ELECTED FOR PALLIATIVE CARE. THE PATIENT PASSED AWAY THREE DAYS LATER. NO AUTOPSY WAS PERFORMED AND THE DEVICE WAS NOT EXPLANTED. IT WAS REPORTED THAT A TRANSESOPHAGEAL ECHOCARDIOGRAM INDICATED THIS DEVICE WAS WORKING PROPERLY. IT ALSO WAS REPORTED THE PATIENT HAD FALLEN TWO OTHER TIMES IN THE FIVE-WEEK PERIOD PRIOR THE HOSPITAL ADMISSION FOR THE HIP PAIN; THE PATIENT WAS TREATED FOR A FRACTURED RIB AFTER THE FIRST FALL AND A SKIN TEAR IN HIS LEFT HAND AFTER THE SECOND. NONE OF THE FALLS WERE ALLEGED TO BE DEVICE-RELATED. IN REPORTING THE DEATH, THE CLINICAL STUDY SITE INDICATED THAT THE ENDOCARDITIS WAS PROBABLY RELATED TO THE DEVICE OR IMPLANT PROCEDURE AND THAT THE SEPSIS WAS POSSIBLY RELATED TO THE DEVICE OR IMPLANT PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    707954 COREVALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT MEDTRONIC HEART VALVES DIVISION MCS-P3-943

    Patients

    Seq Age Sex Outcome Treatment
    1 00089 YR Death| H| R