BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE 3 LVAS IMPLANT KIT

    MDR report key: 15580723 · Received October 11, 2022

    Report

    Report Number
    2916596-2022-14204
    Event Type
    Injury
    Date Received
    October 11, 2022
    Date of Event
    July 31, 2020
    Report Date
    October 12, 2022
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013297
    PMA / PMN Number
    P160054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SPECIFIC PATIENT INFORMATION AND DEVICE SERIAL NUMBER ARE DOCUMENTED AS UNKNOWN. DEVICE WAS IMPLANTED AT TIME OF EVENT. DATE OF EVENT IS APPROXIMATE AS THE DATA WAS COLLECTED BETWEEN (B)(6) 2015 AND (B)(6) 2020. ARTICLE TITLE: IMPACT OF TRENDS IN BODY MASS INDEX ON OUTCOMES IN PATIENTS RECEIVING HEARTMATE 3. DASILVA-DEABREU, A. ET. AL. (2022, JULY 12). EUROPEAN JOURNAL OF HEART FAILURE. HTTPS://DOI.ORG/10.1002/EJHF.2569. THE REPORTABLE AWARE DATE IS THE DATE THE SJM NOTIFIER COMPLETED READING THE ARTICLE AND ENTERED IN THE COMPLAINT DATABASE (PER SECTION 6.3.4 OF 88197). RELATED MFR # 2916596-2022-14205. NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE THE MANUFACTURER¿S INVESTIGATION IS COMPLETED.

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: A DIRECT CORRELATION BETWEEN THE HEARTMATE 3 DEVICES AND THE REPORTED PATIENT OUTCOMES COULD NOT BE CONCLUSIVELY DETERMINED THROUGH THIS EVALUATION. THE PURPOSE OF THIS STUDY WAS TO IDENTIFY PREDICTORS FOR DIFFERENT BODY MASS INDEX (BMI) TRENDS AFTER VAD IMPLANTATION AND THEIR ASSOCIATED CLINICAL OUTCOMES. THE HEARTMATE 3 DEVICE SERIAL NUMBERS, AS WELL AS OTHER SPECIFIC CASE/PATIENT INFORMATION, ARE NOT AVAILABLE. THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED AS THE HEARTMATE 3 DEVICE SERIAL NUMBERS AS WELL AS OTHER SPECIFIC CASE/PATIENT INFORMATION, ARE NOT AVAILABLE. THE HEARTMATE 3 LVAS IFU, REV. C AND THE HEARTMATE 3 LVAS PATIENT HANDBOOK, REV. D ARE CURRENTLY AVAILABLE. SECTION 1, ¿INTRODUCTION,¿ LISTS BLEEDING, AND RENAL DYSFUNCTION AS ADVERSE EVENTS THAT MAY BE ASSOCIATED WITH THE USE OF THE HEARTMATE 3 LVAS. SECTION 6, ¿PATIENT CARE AND MANAGEMENT¿ (UNDER ¿ANTICOAGULATION¿), PROVIDES THE RECOMMENDED ANTICOAGULATION REGIMEN, INCLUDING INTERNATIONAL NORMALIZED RATIO (INR) RANGE, AS WELL AS SUGGESTED ANTICOAGULATION MODIFICATIONS IN THE EVENT THAT THERE IS A RISK OF BLEEDING. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THROUGH THE RESEARCH ARTICLE ¿IMPACT OF TRENDS IN BODY MASS INDEX ON OUTCOMES IN PATIENTS RECEIVING HEARTMATE 3¿ THAT HEARTMATE 3 (HM3) MAY BE ASSOCIATED WITH RENAL FAILURE, GASTROINTESTINAL (GI) BLEEDING, HEMORRHAGE, TRANSPLANT FOR AN UNKNOWN CAUSE AND DEATH. THIS RETROSPECTIVE STUDY INVOLVED 168 PATIENTS WHO HAD THEIR BODY MASS INDEX (BMI) RECORDED PRIOR TO THEIR IMPLANT AND AT 1, 3, 6, 9, AND 12 MONTHS POST-IMPLANT. PATIENTS WERE GROUPED BASED ON THEIR BMI AND IF THEY HAD GAINED OR LOST WEIGHT AT THEIR 12-MONTH FOLLOW-UP. BMI VALUES WERE FOUND TO REACH THEIR LOWEST POINT 1 MONTH AFTER IMPLANT, FOLLOWED BY GRADUAL INCREASES OVER THE REMAINDER OF THE YEAR; VALUES TAKEN AT 6 MONTHS WERE SIMILAR TO BASELINE VALUES (P=0.9017). 59 PATIENTS WHO HAD LOST WEIGHT BY THEIR 12-MONTH FOLLOW-UP HAD A HIGHER BASELINE BMI (30.7 VS. 27.2 KG/M^2; P=0.0052) AND WERE FOUND TO BE MORE LIKELY TO REQUIRE LONG TERM HEMODIALYSIS (3 VS. 0 PATIENTS; P=0.0.35). THESE PATIENTS WERE ALSO MORE LIKELY TO DEVELOP A GI BLEED (28 VS. 33 PATIENTS; P=0.03) AND BLEEDING REQUIRING HOSPITALIZATION OR ADDITIONAL PROCEDURES (28 VS. 32 PATIENTS; P=0.019). PATIENTS WITH A BMI GREATER THAN OR EQUAL TO 25 KG/M^2 AT THEIR 12-MONTH FOLLOW-UP WERE LESS LIKELY TO RECEIVE A HEART TRANSPLANT (1 VS. 21 PATIENTS, P=0.049); BASELINE BMI WAS FOUND TO BE INVERSELY ASSOCIATED WITH THE LIKELIHOOD OF RECEIVING A HEART TRANSPLANT. BASELINE BMI UNDER 35 KG/M^2 WAS ASSOCIATED WITH WEIGHT GAIN AFTER IMPLANT.

    Description of Event or Problem · 0

    RELATED MANUFACTURER REFERENCE NUMBER: 2916596-2022-14205.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    359787 HEARTMATE 3 LVAS IMPLANT KIT VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106524US 00813024013297

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Hospitalization| R