BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM

    MDR report key: 8655585 · Received May 30, 2019

    Report

    Report Number
    2916596-2019-01810
    Event Type
    Injury
    Date Received
    May 30, 2019
    Date of Event
    July 26, 2018
    Report Date
    September 24, 2019
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    PMA / PMN Number
    P160054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    117

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION B5: ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION: PATIENT ADMITTED ON (B)(6) 2018 AND DISCHARGED ON (B)(6) 2018. IT WAS STATED THAT THE PATIENT WAS INDEFINITELY ON CEFADROXIL FOR STAPHYLOCOCCUS (STAPH.) EPIDERMIDIS. THE INFECTION WAS NOT DEVICE RELATED. NO EVIDENCE OF INFECTION ON THE DRIVE LINE EXIT SITE. BACTEREMIA DUE TO GRAM-POSITIVE BACTERIA. PER INFECTIOUS DISEASE PROGRESS NOTE DATED (B)(6) 2018: THE PATIENT HAD HIGH GRADE STAPH EPIDERMIDIS BACTEREMIA. THERE WAS A CONCERN FOR VAD-RELATED INFECTION, THOUGH NO EVIDENCE OF INFECTION ON THE DRIVELINE EXIT SITE WAS REPORTED. ADDITIONAL DIFFERENTIAL DIAGNOSIS (DDX) INCLUDED IE/AICD-RELATED BACTEREMIA, AND A BILIARY SOURCE WAS ALSO IN THE DIFFERENTIAL BUT EXTREMELY UNLIKELY GIVEN ISOLATION OF STAPH. EPIDERMIDIS RATHER THAN STAPH. AUREUS. ON REVIEW OF THE LABS, ESR/CRP WERE ELEVATED ON (B)(6) 2018. BLOOD CULTURES ON (B)(6) 2018 AND (B)(6) 2018 ALSO POSITIVE FOR GPCS. A TRANSTHORACIC ECHOCARDIOGRAM (TTE) ON (B)(6) 2018 SHOWED NO VEGETATIONS. A COMPUTED TOMOGRAPHIC (CT) CHEST ABDOMEN PELVIS (CAP) SHOWED NO DRIVE-LINE TUNNELED INFECTION/ABSCESS. THE PATIENT WAS STARTED ON VANCOMYCIN IV (B)(6) 2018. REPEAT BLOOD CULTURES ON (B)(6) 2018 AND (B)(6) 2018 WERE STILL POSITIVE. CEFAZOLIN WAS ADDED ON (B)(6) 2018 FOR METHICILLIN-SENSITIVE STAPHYLOCOCCUS EPIDERMIDIS (MSSE) (REPEAT SENSI ON THE ISOLATE FROM (B)(6) 2018 STILL SHOWS MSSE). THERE WAS REPORTEDLY A NEGATIVE EVALUATION OF THE DRIVE LINE EXIT SITE. A TEE ON (B)(6) 2018 WAS NEGATIVE. VANCO LEVEL WAS SUPRA-THERAPEUTIC TO 43.8 ON (B)(6) 2018. ON (B)(6) 2018 THE PATIENT RECEIVED A RENAL CONSULT. CREATININE WAS 3.3, THE PATIENT'S BASELINE WAS 0.8. THIS WAS LIKELY MULTIFACTORIAL SECONDARY NEPHROTOXINS (CEFAZOLIN, VANCOMYCIN, LISINOPRIL) AND INFECTION. CT REVEALED NO SIGN OF HYDRONEPHROSIS. PLASMALYTE INITIATED, CREATININE 1.3. BLOOD CULTURES ON (B)(6) 2018 REMAINED NEGATIVE. THE PATIENT'S PORT WAS REMOVED (B)(6) 2018 WITH NEGATIVE CULTURES AT DAY 1. PER DISCUSSION WITH THE VAD SERVICE, A CATH SHOWED SOME HEART RECOVERY. THERE WAS UNCLEAR DISCHARGE (D/C) TIMING AT THIS POINT. IT WAS RECOMMENDED THAT THEY COULD STOP WITH DAILY CULTURES AND CONTINUE CEFAZOLIN (2 G IV Q12HRS) FOR MSSE. THERE WAS NO PLANS FOR VANCOMYCIN DOSES. IT WAS DETERMINED TO BE OKAY TO PLACE A PICC LINE. THERE WAS PLANNED 6 WEEKS OF THERAPY FROM (B)(6) 2018 FOLLOWED BY A STEP DOWN SUPPRESSION IF STILL HAS VAD. PER PROGRESS NOTE DATED (B)(6) 2018: THE PATIENT WAS CONTINUED ON CEFAZOLIN 2GM IV Q 8 HOURS DURING INPATIENT STAY FOR TOTAL 6 WEEKS OF ANTIBIOTIC THERAPY. 6 WEEK ANTIBIOTIC COURSE WAS COMPLETED ON (B)(6) 2018. HE WAS TRANSITIONED TO CEFADROXIL 500MG PO BID FOR CHRONIC SUPPRESSIVE THERAPY.

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING SUBMITTED LATE AS A PART OF THE CORRECTION REQUIRED FOR A CAPA INVESTIGATING REPEATED LATE SUBMISSIONS OF CLINICAL DATA TO THE PRODUCT PERFORMANCE GROUP BY A SINGLE CLINICAL SAFETY EMPLOYEE. ABBOTT NOTIFIED FDA OF THE PENDING LATE REPORTS RELATED TO THIS ISSUE. THE LATE REPORTS RELATED TO THIS CAPA ARE EXPECTED TO BE SUBMITTED TO FDA BY MAY 31, 2019. THE HEARTMATE 3 LVAS WAS IMPLANTED DURING THE MOMENTUM 3 CLINICAL TRIAL, IDE# (B)(4). FDA APPROVAL FOR HEARTMATE 3 LVAS WAS RECEIVED ON 23 AUGUST 2017. THE SAME DEVICE IS USED COMMERCIALLY AND IN THE ONGOING MOMENTUM 3 TRIAL. THE GTIN UNIQUE DEVICE IDENTIFIER FOR THE COMMERCIAL HEARTMATE3 LVAS IS (B)(4). APPROXIMATE AGE OF DEVICE ¿ 1 YEAR. MANUFACTURERS INVESTIGATION CONCLUSION: THE PUMP REMAINS IN USE SUPPORTING THE PATIENT. A CORRELATION BETWEEN THE DEVICE AND THE REPORT OF INFECTION COULD NOT BE CONCLUSIVELY DETERMINED. INFECTION IS LISTED IN THE INSTRUCTIONS FOR USE AS A POTENTIAL ADVERSE EVENT THAT MAY BE ASSOCIATED WITH THE USE OF HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM. INFECTION HAS BEEN PREVIOUSLY INVESTIGATED AND WILL CONTINUE TO BE MONITORED THROUGH QUALITY DATA REVIEWS, WHICH ARE CONDUCTED ON PRODUCTION AND POST PRODUCT SIGNALS TO EVALUATE IF PRODUCTS ARE CONFORMING TO PRODUCT REQUIREMENTS. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 1

    THE PATIENT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD) ON (B)(6) 2017. IT WAS REPORTED THAT THE PATIENT WAS HOSPITALIZED ON (B)(6) 2018 AND INFECTIOUS DISEASES WAS CONSULTED. IT WAS CONCLUDED AS A BLOOD INFECTION. THE PATIENT'S BLOOD CULTURES WERE POSITIVE FOR GRAM-POSITIVE COCCI CLUSTERS. INTRAVENOUS (IV) ANTIBIOTICS WERE ADMINISTERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    449539 HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM LEFT VENTRICULAR ASSIST SYSTEM DSQ THORATEC CORPORATION 106524 6016076

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Hospitalization