BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS

    MDR report key: 3916160 · Received June 6, 2014

    Report

    Report Number
    2916596-2014-00917
    Event Type
    Injury
    Date Received
    June 6, 2014
    Date of Event
    January 1, 2012
    Report Date
    May 6, 2014
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: THIBODEAU E., ET AL. "FIRST REPORT OF A LEFT VENTRICULAR ASSIST DEVICE INFECTION CAUSED BY STAPHYLOCOCCUS SCHLEIFERI SUBSPECIES: A COAGULASE-POSITIVE ORGANISM." DIAGNOSTIC MICROBIOLOGY AND INFECTIOUS DISEASE, 74 (2012) 68-69. THE DATE OF THE EVENT IS AN ESTIMATED DATE.

    Additional Manufacturer Narrative · 1

    BASED ON THE INFORMATION AVAILABLE TO THE MANUFACTURER, A SPECIFIC CAUSE FOR THE REPORTED DRIVELINE INFECTION COULD NOT CONCLUSIVELY BE DETERMINED THROUGH THIS EVALUATION. NO PATIENT OR DEVICE INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING ITS FILE ON THIS EVENT.

    Description of Event or Problem · 1

    THIS PT WAS NOTED THROUGH LITERATURE REVIEW. IT WAS REPORTED IN A CASE REPORT THAT A PT DEVELOPED AN INFECTION 3 MONTHS POST IMPLANTATION OF THE LVAD AT THEIR HM II DRIVELINE EXIT SITE. THE PT WAS TREATED WITH 10 DAYS OF ORAL TRIMETHOPRIM-SULFAMETHOXAZOLE 160/800 MG TWICE DAILY. SEVEN WEEKS LATER, THE PT AGAIN REDEVELOPED DRAINAGE AT THE LVAD EXIT SITE. ON THIS SECOND OCCASION, THERE WAS SURROUNDING ERYTHEMA AND THE PT FELT SYSTEMICALLY FATIGUED WITH DESCRIPTION OF SUBJECTIVE CHILLS. THE PT HAD A PET CAT AND PET DOG. HER LABORATORY VALUES WERE SIGNIFICANT FOR WHILE BLOOD CELLS WITH 79% NEUTROPHILS. ALL OTHER LABORATORY DATA WERE NORMAL INCLUDING NEGATIVE BLOOD CULTURES. COMPUTED TOMOGRAPHY SCAN OF THE ABDOMEN SHOWED A SMALL AMOUNT OF FLUID SURROUNDING THE LVAD OUTFLOW TUBING; HOWEVER, NO LARGE FLUID COLLECTIONS WERE SEEN. GRAM STAIN FROM HER LVAD DRIVELINE SITE DRAINAGE SHOWED NO WHITE BLOOD CELLS BUT GRAM-POSITIVE COCCI IN CLUSTERS WITH POSITIVE TUBE COAGULATE TEST. THE SPECIES WAS INITIALLY IDENTIFIED AS (B)(6) AND THE PT WAS LATER STARTED ON VANCOMYCIN THEREBY. LATER, THE ISOLATE WAS IDENTIFIED TO BE S. SCHLEIFERI SUBSPECIES COAGULANS, STAPHYLOCOCCUS SCHLEIFERI SUBSPECIES COAGULANS IS OFTEN MISCLASSIFIED AS (B)(6) GIVEN THE PRODUCTION OF A PSEUDOCAGULASE TURNING THE TUBE COAGULASE TEST POSITIVE. WE DESCRIBE THE FIRST CASE OF S. SCHLEIFERI SUBSPECIES COAGULANS LEFT VENTRICULAR ASSIST DEVICE INFECTION IN A PT AWAITING HEART TRANSPLANTATION. THE PT LATER UNDERWENT SUCCESSFUL HEART TRANSPLANTATION AND EXPERIENCED NO INFECTIOUS COMPLICATIONS POSTOPERATIVELY. IT WAS ALSO REPORTED IN THE CASE REPORT THAT EVEN THAT THIS ORGANISM IS MOST COMMONLY FOUND IN DOGS, THIS CASE EXEMPLIFIES THE IMPORTANCE OF OBTAINING A SOCIAL HISTORY AND CONTACT WITH ANIMALS. WE SUSPECT THAT THIS PT BECAME INFECTED WITH S. SCHLEIFERI THROUGH CONTACT WITH HER DOG BUT WE WERE UNABLE TO CULTURE THE PET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    331110 HEARTMATE II LVAS DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 104911

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention