BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE 3 LVAS IMPLANT KIT

    MDR report key: 11756132 · Received April 30, 2021

    Report

    Report Number
    2916596-2021-02131
    Event Type
    Injury
    Date Received
    April 30, 2021
    Date of Event
    March 31, 2021
    Report Date
    July 7, 2021
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013297
    PMA / PMN Number
    P160054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER¿S INVESTIGATION IS COMPLETED

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: REVIEW OF THE SUBMITTED LOG FILES CONFIRMED LOW FLOW ALARMS; HOWEVER, THE LOW FLOW ALARMS WERE REPORTEDLY DUE TO EXISTING HYPOVOLEMIA. A DIRECT CORRELATION BETWEEN HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS), SERIAL NUMBER (B)(6) , AND THE REPORTED EVENTS COULD NOT BE CONCLUSIVELY ESTABLISHED THROUGH THIS EVALUATION. THE SUBMITTED LOG FILES COLLECTIVELY CONTAINED DATA FROM (B)(6) 2021 AND FOUND THAT THE PUMP OPERATED AT THE SET SPEED WITHOUT ISSUE. MULTIPLE LOW FLOW CONTROLLER FAULT FLAGS WERE CAPTURED ON (B)(6) 2021, WITH MULTIPLE INSTANCES LASTING 10 SECONDS OR LONGER TO RESULT IN TRANSIENT LOW FLOW HAZARD ALARMS. SLIGHTLY ELEVATED PULSATILITY INDEX (PI) VALUES WERE ALSO NOTED DURING MOST OF THE LOW FLOW EVENTS. THE SYSTEM APPEARED TO BE OPERATING AS INTENDED, AND THERE WERE NO OTHER NOTABLE ALARMS ACTIVE IN THE LOG FILES. A LOW FLOW SOFTWARE UPGRADE FOR BOTH PATIENT¿S SYSTEM CONTROLLERS WAS PERFORMED ON (B)(6) 2021. THE PATIENT REMAINS ONGOING ON (B)(6) . THE RELEVANT SECTIONS OF THE DEVICE HISTORY RECORDS FOR (B)(6) WERE REVIEWED AND SHOWED NO DEVIATIONS FROM MANUFACTURING OR QUALITY ASSURANCE SPECIFICATIONS. THE IMPLANT KIT WAS SHIPPED ON 11MAR2021. THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS) INSTRUCTIONS FOR USE (IFU), REV. C IS CURRENTLY AVAILABLE. SECTION 1 ¿INTRODUCTION¿ OF THIS DOCUMENT LISTS BLEEDING, CARDIAC ARRHYTHMIA, HEPATIC DYSFUNCTION, RIGHT HEART FAILURE, AND HYPERTENSION AS ADVERSE EVENTS THAT MAY BE ASSOCIATED WITH THE USE OF THE HEARTMATE 3 LVAS. SECTION 6 ¿PATIENT CARE AND MANAGEMENT¿ PROVIDES INFORMATION REGARDING THE RECOMMENDED ANTICOAGULATION THERAPY AND INR (INTERNATIONAL NORMALIZED RATIO) RANGE, AS WELL AS CONSIDERATIONS FOR WHEN THERE IS A RISK OF BLEEDING. ADDITIONALLY, SECTION 6 (UNDER ¿RIGHT HEART FAILURE¿) OUTLINES INDICATIONS OF RIGHT HEART FAILURE AS WELL AS POSSIBLE TREATMENTS. SECTION 6 STATES THAT POST-IMPLANTATION HYPERTENSION MAY BE TREATED AT THE DISCRETION OF THE ATTENDING PHYSICIAN, AND ANY THERAPY THAT CONSISTENTLY MAINTAINS MEAN ARTERIAL BLOOD PRESSURE LESS THAN 90 MM HG (MILLIMETERS OF MERCURY) SHOULD BE CONSIDERED ADEQUATE. SECTION 1 ¿INTRODUCTION¿ OF THIS DOCUMENT PROVIDES AN EXPLANATION OF ALL PUMP PARAMETERS, INCLUDING FLOW. THIS SECTION EXPLAINS THAT PUMP FLOW IS A CALCULATED VALUE THAT IS ESTIMATED BASED ON PUMP POWER. SECTION 4 ¿SYSTEM MONITOR¿ PROVIDES INFORMATION ABOUT THE PUMP FLOW DISPLAY AND THE LOW FLOW HAZARD ALARM CONDITION. THIS SECTION STATES THAT THE LOW FLOW HAZARD ALARM WILL BE TRIGGERED WHEN THE ESTIMATED PUMP FLOW IS LESS THAN 2.5 LPM (LITERS PER MINUTE) AND EXPLAINS THAT CHANGES IN PATIENT CONDITIONS CAN RESULT IN LOW FLOW. ADDITIONALLY, THIS SECTION (UNDER ¿OPTIMAL FIXED SPEED¿) OUTLINES HOW TO DETERMINE THE OPTIMAL FIXED SPEED AND LOW SPEED LIMIT. SECTION 7 ¿ALARMS AND TROUBLESHOOTING¿ DESCRIBES ALL ALARM CONDITIONS, INCLUDING THE LOW FLOW HAZARD, AS WELL AS THE APPROPRIATE ACTIONS ASSOCIATED WITH THEM. THE HEARTMATE 3 LVAS PATIENT HANDBOOK, REV. C IS CURRENTLY AVAILABLE. SECTION 5 "ALARMS AND TROUBLESHOOTING" OUTLINES ALL SYSTEM CONTROLLER ALARMS AS WELL AS HOW TO RESPOND TO EACH ALARM CONDITION. THIS DOCUMENT INSTRUCTS THE USER THAT IN THE EVENT OF A LOW FLOW HAZARD ALARM, CALL YOUR HOSPITAL CONTACT IMMEDIATELY FOR DIAGNOSIS AND INSTRUCTIONS. THE HM3 (HEARTMATE 3) LVAS POCKET GUIDES TO ALARMS FOR PATIENTS (REV. A) AND CLINICIANS (REV. A) EXPLAIN THAT THE LOW FLOW HAZARD ALARM WILL BE TRIGGERED WHEN THE ESTIMATED PUMP FLOW IS LESS THAN 2.0 LPM. 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 LOW FLOW ALARMS WERE DUE TO HYPOVOLEMIA. THE ALARMS WERE ADDRESSED WITH A LOW FLOW SOFTWARE UPGRADE. TACHYCARDIA IMPROVED WITH VOLUME RESUSCITATION AND ELECTROLYTE REPLETION. THE CARDIAC ARRHYTHMIA RESOLVED WITHOUT SEQUALAE ON (B)(6) 2021. IT WAS NOTED THAT THE PATIENT HAD IMPAIRED AEROBIC CAPACITY AND ENDURANCE DUE TO DECONDITIONING ON (B)(6) 2021. THE PATIENT EXPERIENCED HEPATIC DYSFUNTION AND TRANSAMINITIS WITH PEAK ASPARTATE AMINOTRANSFERASE OF 3197 AND ALANINE TRANSAMINASE OF 2300 ON (B)(6) 2021. THIS RESOLVED WITHOUT SEQUELAE ON (B)(6) 2021. THE PATIENT ALSO HAD RIGHT VENTRICULAR DYSFUNCTION WHICH REQUIRED PROLONGED INOTROPE USE AND NITRIC OXIDE INHALATION. THIS RESOLVED WITHOUT SEQUELAE ON (B)(6) 2021. THE PATIENTS BLEEDING RESOLVED WITHOUT SEQUELAE ON (B)(6) 2021. THE PATIENT WAS GIVEN MIRTAZAPINE FOR LOSS OF APPETITE ON (B)(6) 2021. THE PATIENT WAS ALSO ON MEGESTROL PRE-OPERATION FOR APPETITE. THE PATIENT ALSO EXPERIENCED RIB PAIN REQUIRING ULTRAM ON (B)(6) 2021. DAYTIME SLEEPINESS WAS ALSO NOTED WHICH REQUIRED RITALIN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD LOW HEMATOCRIT WHICH REQUIRED 280 MILLILITERS OF BLOOD TRANSFUSION ON (B)(6) 2021 AS WELL AS 560 MILLILITERS ON (B)(6) 2021. AN ILEUS WAS NOTED ON ABDOMEN X-RAY ON (B)(6) 2021 AND THE PATIENT WAS GIVEN METHYLNALTREXONE. RECTAL TUBE WAS PUT IN ON (B)(6) 2021 FOR GASTRIC DECOMPRESSION WITH TUBE TO BE REMOVED ON (B)(6) 2021. THIS EVENT RESOLVED WITHOUT SEQUELAE. THE PATIENTS CARDIAC ARRHYTHMIA RESOLVED WITHOUT SEQUELAE ON (B)(6) 2021 AND WAS GIVEN BLOOD PRODUCTS. THE PATIENT WAS DISCHARGED HOME ON (B)(6) 2021.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2021 THE CHEST WAS RE-EXPLORED DUE TO BLEEDING AFTER CHEST CLOSURE POST IMPLANT. THE PATIENT HAD SEVERAL SELF-LIMITING RUNS OF VENTRICULAR TACHYCARDIA. THIS RESOLVED WITH VOLUME RESUSCITATION AND ELECTROLYTE REPLETION ON (B)(6) 2021. THE PATIENT DEVELOPED POST-OPERATION PAROXYSMAL ATRIAL FIBRILLATION AND RECEIVED AMIODARONE BOLUS ON (B)(6) 2021. THIS WAS POSSIBLY RELATED TO THE IMPLANT PROCEDURE AND THE PATIENT WAS IN AN ONGOING, STABLE CONDITION. ANEMIA REQUIRING BLOOD TRANSFUSIONS WAS NOTED ON (B)(6) 2021 AND (B)(6) 2021. THE PATIENT EXPERIENCED RIGHT HEART FAILURE ON (B)(6) 2021. COMPUTED TOMOGRAPHY (CT) OF THE CHEST WAS DONE ON (B)(6) 2021 WHICH FOUND HEMATOMA WITH COMPRESSION OF THE RIGHT VENTRICLE AND TAMPONADE PHYSIOLOGY. REOPERATION FOR EVACUATION OF A MEDIASTINAL HEMATOMA WAS DONE. THE PATIENT UNDERWENT RESUSCITATION, SURGERY, AND BLOOD PRODUCTS HAD TO BE ADMINISTERED. THIS WAS POTENTIALLY RELATED TO THE IMPLANT PROCEDURE AND WAS CONSIDERED RESOLVED WITHOUT SEQUELAE ON (B)(6) 2021. THE PATIENT WAS STABLE UNTIL THEY EXPERIENCED PERSISTENT LOW FLOW WITH ELEVATED PULSATILITY INDEX (PI) ON (B)(6) 2021. THE PATIENT¿S BLOOD PRESSURE WAS 100 AND CAME DOWN WITH MEDICATION. THE FLOWS INCREASED TO 2.9 LPM WITH PI OF 6.6. LOG FILE ANALYSIS CAPTURED LOW FLOW EVENTS THROUGHOUT. THE PATIENT WAS REPORTEDLY ASYMPTOMATIC AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    650944 HEARTMATE 3 LVAS IMPLANT KIT VENTRICULAR (ASSISST) BYPASS DSQ THORATEC CORPORATION 106524US 7854723 00813024013297

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization| R