BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE 3 LVAS IMPLANT KIT

    MDR report key: 10345858 · Received July 30, 2020

    Report

    Report Number
    2916596-2020-03584
    Event Type
    Injury
    Date Received
    July 30, 2020
    Date of Event
    July 3, 2020
    Report Date
    October 15, 2020
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013297
    PMA / PMN Number
    P160054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S 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 · 0

    IT WAS REPORTED THAT THE DATE OF ONSET FOR RIGHT VENTRICULAR FAILURE WAS ON (B)(6) 2020. IT WAS REPORTED THAT THERE WERE NO DEVICE ISSUES THAT CAUSED OR CONTRIBUTED TO THE RIGHT HEART FAILURE. THE PATIENT WAS NON-COMPLIANT WITH SODIUM/FLUID RESTRICTIONS. THE PATIENT EXPERIENCED SEVERE SHORTNESS OF BREATH, HUGE DIURESIS, WITH NO CHANGE IN WEIGHT. PATIENT WAS INTUBATED & DOBUTAMINE & BUMEX INTRAVENOUS (IV) DRIP.

    Additional Manufacturer Narrative · 1

    (B)(6) 2019 ADMISSION WAS REPORTED IN RELATED MANUFACTURER'S REPORT NUMBER: 2916596-2020-03876. (B)(6) 2020 ADMISSION WAS REPORTED IN RELATED MANUFACTURER'S REPORT NUMBER: 2916596-2020-03882. (B)(6) 2020 ADMISSION WAS REPORTED IN RELATED MANUFACTURER'S REPORT NUMBER: 2916596-2020-03860. NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER¿S INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    RELATED MANUFACTURER'S REPORT NUMBER: 2916596-2020-03872. IT WAS REPORTED THAT THE PATIENT UNDERWENT PUMP EXCHANGE ON (B)(6) 2020 FROM HEARTMATE 3 (MLP-015103) TO HEARTMATE 3 (MLP-022305). ACCORDING TO INFORMATION PROVIDED BY VAD COORDINATOR, PATIENT HAS STRUGGLED WITH PERSISTENT PSEUDOMONAS DRIVELINE INFECTION POST IMPLANT. HE HAS HAD MULTIPLE DEBRIDEMENTS AND WOUND VACS AND COURSES OF IV AND ORAL ANTIBIOTICS. LAST ADMISSION WAS ON (B)(6) 2020. ON (B)(6) 2020 FOR PSEUDOMONAS (2 SPECIES) LVAD DRIVELINE INFECTION AND CONCERN FOR TRANSIENT BACTEREMIA FROM DRIVELINE SITE. DECISION WAS MADE TO EXCHANGE THE VAD AS IT WAS BELIEVED TO BE INFECTED. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION, IT WAS OTHERWISE WORKING APPROPRIATELY. IT WAS REPORTED THAT THE PATIENT CURRENTLY REMAINS HOSPITALIZED IN RIGHT VENTRICULAR FAILURE. BLOOD CULTURES FROM (B)(6) 2020 WERE PENDING, BUT THE PATIENT POSSIBLY HAS ASPIRATION PNEUMONITIS VERSUS BILATERAL PULMONARY EDEMA. HE CONTINUES TO BE TREATED WITH CEFTAZADIME. IT WAS REPORTED THAT THE PATIENT'S FIRST ADMISSION FOR DRIVELINE INFECTION WAS (B)(6) 2019 ((B)(6)) AND FIRST DEBRIDEMENT WITH WOUND VAC WAS (B)(6) 2019 WHICH WAS DISCONTINUED (B)(6) 2019. THE SECOND ADMISSION FOR DRIVELINE INFECTION WAS (B)(6) 2020 WITH PSEUDOMONAS AERUGINOSA (2 STRAINS). DEBRIDEMENT DONE (B)(6) 2020 WITH VAC PLACEMENT WHICH WAS DISCONTINUED (B)(6) 2020. THE THIRD ADMISSION WAS (B)(6) 2020 WITH ¿SEPTIC PICTURE¿, BLOOD CULTURES NEGATIVE. DEBRIDEMENT DONE (B)(6) 2020 AND NO VAC PLACED. THERE WERE COPIOUS AMOUNTS OF DRAINAGE FROM THE DRIVELINE SITE WITHIN A FEW SHORT WEEKS AFTER EACH TIME THE VAC WAS DISCONTINUED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    809030 HEARTMATE 3 LVAS IMPLANT KIT VENTRICULAR (ASSISST) BYPASS DSQ THORATEC CORPORATION 106524US 6773863 00813024013297

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Hospitalization| R HEARTMATE 3 LVAS IMPLANT KIT MLP-022305