BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM

    MDR report key: 10906409 · Received November 25, 2020

    Report

    Report Number
    2916596-2020-05677
    Event Type
    Injury
    Date Received
    November 25, 2020
    Date of Event
    April 1, 2020
    Report Date
    December 30, 2020
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    PMA / PMN Number
    P160054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: A DIRECT CORRELATION BETWEEN THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM AND THE REPORTED EVENTS (GASTROINTESTINAL BLEEDING AND STROKE) CANNOT BE CONCLUSIVELY DETERMINED THROUGH THIS EVALUATION. A STUDY CONDUCTED BY THE UNIVERSITY OF MINNESOTA STATED THAT INFLAMMATION AND CONGESTION MAY CONTRIBUTE TO STROKE AND GASTROINTESTINAL BLEEDING (GIB) IN LEFT VENTRICULAR ASSIST DEVICE (LVAD) PATIENTS. C-REACTIVE PROTEIN (CRP), ERYTHROCYTE SEDIMENTATION RATE (ESR), AND N-TERMINAL-PRO B-TYPE NATRIURETIC PEPTIDE (NT-PROBNP) ARE ESTABLISHED BIOMARKERS OF INFLAMMATION AND CONGESTION. THE STUDY AIMED TO INVESTIGATE THE ASSOCIATION OF THESE BIOMARKERS WITH STROKE AND GIB IN LVAD PATIENTS WHO SURVIVED TO THEIR FIRST OUTPATIENT VISIT. SERUM CRP, ESR, AND NT-PROBNP WERE PROSPECTIVELY MEASURED IN CONSECUTIVE LVAD PATIENTS AT OUTPATIENT VISITS. PATIENTS WITH STROKE OR GIB PRIOR TO THEIR FIRST VISIT WERE EXCLUDED FROM THE RESPECTIVE ANALYSIS. BIOMARKER LEVELS WERE AVERAGED TO THE DATE OF THE OUTCOME OF INTEREST. RECEIVER OPERATING CHARACTERISTIC (ROC) CURVES WERE CONSTRUCTED TO IDENTIFY THE OPTIMAL BIOMARKER CUTOFF POINTS TO PREDICT STROKE AND GIB. MULTIVARIABLE COX PROPORTIONAL HAZARD MODELS WERE BUILT TO ASSESS THE ASSOCIATION OF CRP WITH STROKE AND GIB AFTER ADJUSTING FOR AGE, GENDER, BODY MASS INDEX (BMI), DIABETES, INTERMACS PROFILE, AND NT-PROBNP. A TOTAL OF 228 LVAD PATIENTS (105 HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM AND 105 HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM, AND 18 OTHERS) WERE ENROLLED. TWO HUNDRED AND SIXTEEN PATIENTS MET THE INCLUSION FOR THE GIB ANALYSIS AND 223 FOR THE STROKE ANALYSIS. THE MEDIAN FOLLOW-UP WAS 829 [408-1196] AND 857 [464-1209] DAYS, RESPECTIVELY. THIRTY-FIVE PATIENTS EXPERIENCED A GIB AND 24 HAD A STROKE AT A MEDIAN FOLLOW-UP OF 223 [120-695] AND 415 [164-768] DAYS. MEDIAN CRP, ESR AND NT-PROBNP WERE 14.6 [7.27-30.7]MG/L, 38.3 [25.8-55.5]MM/HOUR, AND 1144 [655-2314]PG/ML FOR GIB, AND 22 [6.14-30.5]MG/L, 41.7 [25.1-53.0]MM/HOURR, AND 1157 [662-2366]PG/ML FOR STROKE. THE ROC CURVES IDENTIFIED SIGNIFICANT CUTOFFS ONLY FOR CRP: 15.5 MG/L (AUC 0.66, P15.5 MG/L WAS AN INDEPENDENT PREDICTOR OF STROKE (HR 4.2 95% CI 1.6-11.1, P=0.004) AND CRP>8 MG/L WAS AN INDEPENDENT PREDICTOR OF GIB (HR 3.0 95% CI 1.0-8.6, P=0.04). THE STUDY CONCLUDED THAT ELEVATED OUTPATIENT CRP IS AN INDEPENDENT PREDICTOR OF STROKE AND GIB IN LVAD RECIPIENTS. THE DEVICE HISTORY RECORDS WERE NOT REVIEWED BECAUSE THE SERIAL NUMBERS OF THE IMPLANTED HEARTMATE 3 LEFT VENTRICULAR ASSIST DEVICES ARE UNKNOWN. THE REFERENCED STUDY CONSISTED OF 105 HEARTMATE 3 LEFT VENTRICULAR ASSIST DEVICE PATIENTS. THE HEARTMATE 3 LEFT VENTRICULAR ASSIST DEVICE SERIAL NUMBERS, AS WELL AS OTHER SPECIFIC CASE/PATIENT INFORMATION, ARE NOT AVAILABLE AND WERE NOT REQUESTED. THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM INSTRUCTIONS FOR USE LISTS BLEEDING AND STROKE AS ADVERSE EVENTS THAT MAY BE ASSOCIATED WITH THE USE OF HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM. THE INSTRUCTIONS FOR USE PROVIDES INFORMATION REGARDING ANTICOAGULATION, INCLUDING RECOMMENDED INTERNATIONAL NORMALIZED VALUES, AND THE 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.

    Additional Manufacturer Narrative · 1

    SPECIFIC PATIENT INFORMATION AND DEVICE SERIAL NUMBER ARE DOCUMENTED AS UNKNOWN. DATE OF EVENT HAS BEEN ENTERED AS THE SAME AS PUBLISHED DATE (APRIL 2020) SINCE DATE OF DATA COLLECTION WAS NOT PROVIDED. Y. BRAILOVSKY, ET AL. JOURNAL OF HEART AND LUNG TRANSPLANTATION, VOLUME: 39, ISSUE: 4, PAGES: S396. DOI: 10.1016/J.HEALUN.2020.01.529 MEDICINE, COLUMBIA UNIVERSITY MEDICAL CENTER, NEW YORK. NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER¿S INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THROUGH THE RESEARCH ABSTRACT ¿ELEVATED OUTPATIENT C-REACTIVE PROTEIN INDEPENDENTLY PREDICTS STROKE AND GASTROINTESTINAL BLEEDING IN LVAD PATIENTS¿ IDENTIFYING THAT THE HEARTMATE 3 WAS RELATED WITH GASTROINTESTINAL (GI) BLEEDING AND STROKE, AND C-REACTIVE PROTEIN WAS CONSIDERED AS AN INDEPENDENT PREDICTOR OF BOTH ADVERSE EVENTS. THE AIM OF THIS STUDY WAS TO EVALUATE THE ASSOCIATION OF INFLAMMATORY BIOMARKERS (C-REACTIVE PROTEIN (CRP), ERYTHROCYTE SEDIMENTATION RATE (ESR), AND N-TERMINAL-PRO B-TYPE NATRIURETIC PEPTIDE (NT-PROBNP)) WITH STROKE AND GI BLEEDING IN PATIENTS IMPLANTED WITH LVAD. A TOTAL OF 228 LVAD PATIENTS WERE EVALUATED, 105 IMPLANTED WITH HM3 AND 123 WITH ANOTHER LVAD. THE PATIENTS WERE ENROLLED IN COHORT 1 FOR GI BLEED AND COHORT 2 FOR STROKE. A TOTAL OF 35 PATIENTS EXPERIENCED GI BLEED AND 24 HAD STROKE AT A MEDIAN FOLLOW UP OF 223 [120-695] AND 415 [164-768] DAYS, CONSECUTIVELY. MEDIAN CRP, ESR AND NT-PROBNP WERE 14.6 [7.27-30.7] MG/L, 38.3 [25.8-55.5] MM/HR, AND 1144 [655-2314] PG/ML IN COHORT 1, AND 22 [6.14-30.5] MG/L, 41.7 [25.1-53.0] MM/HR, AND 1157 [662-2366] PG/ML IN COHORT 2. ALSO, IT WAS DEMONSTRATED THAT CRP GREATER THAN 15.5 MG/L WAS AN INDEPENDENT PREDICTOR OF STROKE (P=0.004) AND CRP>8 MG/L WAS AN INDEPENDENT PREDICTOR OF GI BLEED (P=0.04). DEVICE WAS IMPLANTED AT TIME OF EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1371262 HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM VENTRICULAR (ASSISST) BYPASS DSQ THORATEC CORPORATION 106524

    Patients

    Seq Age Sex Outcome Treatment
    1 Other