BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE 3 LVAS IMPLANT KIT

    MDR report key: 13695328 · Received March 8, 2022

    Report

    Report Number
    2916596-2022-01102
    Event Type
    Injury
    Date Received
    March 8, 2022
    Date of Event
    February 8, 2022
    Report Date
    April 4, 2022
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013297
    PMA / PMN Number
    P160054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    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: THE PATIENT REMAINS ONGOING WITH HEARTMATE 3 LVAS, SERIAL NUMBER (B)(6). A DIRECT CORRELATION BETWEEN HEARTMATE 3 (HM3) LEFT VENTRICULAR ASSIST SYSTEM (LVAS), SERIAL NUMBER (B)(6), AND THE REPORTED CARDIAC ARRHYTHMIA, RIGHT HEART FAILURE, HEPATIC DYSFUNCTION, INFECTION, VENOUS THROMBOEMBOLISM, PERICARDIAL FLUID COLLECTION, PATIENT CONDITIONS (HYPOTENSION AND PULMONARY EDEMA), HYPERTENSION, ANEMIA, AND THROMBOCYTOPENIA COULD NOT CONCLUSIVELY BE DETERMINED THROUGH THIS EVALUATION. MULTIPLE REQUESTS FOR ADDITIONAL INFORMATION WERE ISSUED TO THE CUSTOMER; HOWEVER, NO FURTHER INFORMATION WAS PROVIDED. HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS) INSTRUCTIONS FOR USE (IFU) IS CURRENTLY AVAILABLE. SECTION 1 ENTITLED ¿INTRODUCTION¿ LISTS CARDIAC ARRHYTHMIA, RIGHT HEART FAILURE, HEPATIC DYSFUNCTION, INFECTION, VENOUS THROMBOEMBOLISM, PERICARDIAL FLUID COLLECTION, HYPERTENSION, AND BLEEDING AS ADVERSE EVENTS THAT MAY BE ASSOCIATED WITH THE USE OF THE HEARTMATE 3 LVAS. SECTION 6 ¿PATIENT CARE AND MANAGEMENT¿ LISTS ARRHYTHMIA, INFECTION, AND THROMBOEMBOLISM AS POTENTIAL LATE POSTIMPLANT COMPLICATIONS THAT MAY BE ASSOCIATED WITH THE USE OF HEARTMATE 3 LVAS. CARE INSTRUCTIONS REGARDING PREVENTING INFECTION ARE PROVIDED IN VARIOUS SECTIONS OF THE IFU, INCLUDING ¿CARING FOR THE DRIVELINE EXIT SITE¿ AND ¿CONTROLLING INFECTION¿. THIS DOCUMENT ALSO DISCUSSES THE POTENTIAL DEVELOPMENT OF RIGHT HEART FAILURE FOLLOWING IMPLANT AND OUTLINES THE ASSOCIATED TREATMENT OPTIONS. SECTION 1, "INTRODUCTION," EXPLAINS THAT VENTRICULAR BLOOD MAY FLOW EITHER THROUGH THE LEFT VENTRICULAR ASSIST DEVICE (LVAD) OR THE AORTIC VALVE TO REACH THE AORTA, THE PROPORTION OF WHICH DEPENDS GREATLY UPON THE DEGREE OF THE PATIENT'S CARDIAC FUNCTION AND THE SET SPEED OF THE LVAD. SECTION 5 "SURGICAL PROCEDURES" (UNDER ¿PREPARING THE VENTRICULAR APEX SITE¿) INSTRUCTS TO INSPECT THE VENTRICULAR CHAMBER FOR MURAL THROMBI AND CROSSING TRABECULAE FOLLOWING REMOVAL OF THE CORE AND TO ADDRESS ONE OR BOTH, AS NEEDED. THIS SECTION ALSO STATES THAT PUMP FUNCTION WILL BE COMPROMISED IN THE PRESENCE OF INLET OBSTRUCTION. SECTION 5 (UNDER ¿IMPLANT PROCEDURES¿) ADDITIONALLY WARNS TO INSPECT THE VENTRICLE AND REMOVE ANY PREVIOUSLY FORMED CLOTS THAT MAY CAUSE EMBOLISM OR ANY TRABECULAE THAT MAY IMPEDE FLOW. SECTION 6 "PATIENT CARE AND MANAGEMENT" (UNDER "ANTICOAGULATION") CONTAINS INFORMATION REGARDING THE RECOMMENDED ANTICOAGULATION THERAPY FOR PATIENTS USING THE DEVICE. SECTION 6 OF THE IFU, UNDER ¿BLOOD PRESSURE MANAGEMENT¿, STATES THAT POST-IMPLANTATION HYPERTENSION MAY BE TREATED AT THE DISCRETION OF THE ATTENDING PHYSICIAN. ANY THERAPY THAT CONSISTENTLY MAINTAINS MEAN ARTERIAL BLOOD PRESSURE LESS THAN 90 MM HG SHOULD BE CONSIDERED ADEQUATE. SECTION 1, ¿INTRODUCTION,¿ 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 LITERS PER MINUTE (LPM) AND EXPLAINS THAT CHANGES IN PATIENT CONDITIONS CAN RESULT IN LOW FLOW. 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, DOCUMENT (B)(4), REV. D, IS ALSO AVAILABLE. SEVERAL SECTIONS OF THIS HANDBOOK PROVIDE CARE INSTRUCTIONS REGARDING PREVENTING INFECTION. 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 RELEVANT SECTIONS OF THE DEVICE HISTORY RECORDS FOR (B)(6) WERE REVIEWED AND SHOWED NO DEVIATIONS FROM MANUFACTURING OR QUALITY ASSURANCE SPECIFICATIONS. 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 PATIENT WAS IMPLANTED WITH THE DEVICE ON (B)(6) 2022. THE PATIENT EXPERIENCED VENTRICULAR FIBRILLATION (VF) DURING SURGERY, THE PATIENT WAS CARDIOVERTED ONCE AND THE ISSUE RESOLVED. THE PATIENT EXPERIENCED ATRIAL FIBRILLATION (A-FIB) WITH RAPID VENTRICULAR RESPONSE (RVR) ON (B)(6) 2022, AND TREATED WITH NITRIC OXIDE AND AMIODARONE INFUSION, CONVERTED BACK TO NORMAL SINUS RHYTHM THE NEXT DAY, WHILE WEANING AMIODARONE, ARRHYTHMIA RETURNED. ANEMIA WAS ALSO NOTED, HEMOGLOBIN AND HEMATOCRIT WERE AS FOLLOWS: 12.4/38,POD 1 10.2/30.7, 9.7/28.6, 9.9/30.2, 2/15/2022 9.5/29.6. ON (B)(6) 2022, THE PATIENT WAS HYPERTENSIVE, EPINEPHRINE WAS ADJUSTED TO 1 MICROGRAMS/ MINUTE AND DOBUTAMINE DRIP TO 2.5 MCG/ KG/MIN; LOW DOSE NICARDIPINE WAS STARTED TO MAINTAIN MAP OF LESS THAN 90 MILLIMETERS OF MERCURY (MMHG). THE DEVICE HAD LOW FLOW ALARMS, THIS WAS ATTRIBUTED TO LOW CENTRAL VENOUS PRESSURE (CVP); THE PATIENT WAS GIVEN BOLUSES OF LACTATED RINGERS SOLUTION AND ALBUMIN. THE PATIENT ALSO EXPERIENCED THROMBOCYTOPENIA, POST-OPERATIVE PLATELET VALUE AS FOLLOW: 111 (B)(6) 2022, (B)(6) 2022 80-66, (B)(6) 2022 68. ON (B)(6) 2022; THE PATIENT HAD HEPATIC DYSFUNCTION/ ACUTE HEPATIC INJURY, LIVER FUNCTION TEST (LFT)S HIGH, THIS WAS ATTRIBUTED TO HYPOPERFUSION. ABDOMINAL ULTRASOUND WAS DONE. ON (B)(6) 2022, PATIENT WAS STARTED ON COLCHICINE FOR POSSIBLE PERICARDITIS, THIS IMPROVED WITH DRAINAGE. ON (B)(6) 2022, THE PATIENT HAD RIGHT HEART FAILURE, REMAINS ON MILRINONE 0.25MCQ/KG/MIN. LOW FLOW ALARMS WERE AGAIN NOTED, THE PATIENT HAD LOW CVP, LASIX DISCONTINUED, AND FLUIDS WERE GIVEN. MILRINONE MAINTAINED AND WAS SUCCESSFULLY WEANED OFF ON (B)(6) 2022. SILDENAFIL WAS ADDED FOR RIGHT VENTRICLE (RV) SUPPORT DURING THE WEANING PROCESS. ON (B)(6) 2022 THE PATIENT¿S WHITE BLOOD COUNT (WBC¿S) TRENDING UP; WBC 13.44 PAN CULTURE DONE; BLOOD CULTURES NEGATIVE; URINE ANALYSIS UNREMARKABLE. THE PATIENT WAS POSITIVE FOR RESPIRATORY CULTURE WITH CITROBACTER KOSERI. ZOSYN STARTED ON (B)(6) 2022 VIA INTRAVENOUS INFUSION (IV). THE PATIENT EXPERIENCED PULMONARY EDEMA; IV LASIX WAS RESTARTED. ON (B)(6) 2022, CHEST X RAY SHOWED MODERATE LEFT AND LAYERING RIGHT PLEURAL EFFUSION. FURTHER DIAGNOSTIC TEST DONE THRU CHEST CT ON (B)(6) 2022 AND FOUND LARGE LEFT AND TRACE RIGHT PLEURAL EFFUSIONS AND ASSOCIATED COMPRESSIVE ATELECTASIS."MULTIFOCAL AIRSPACE OPACITIES WITHIN THE RIGHT LOWER LOBE LIKELY REPRESENT PNEUMONIA. ON (B)(6) 2022, CHEST TUBE WAS PLACED VIA INTERVENTIONAL RADIOLOGY GUIDANCE. ON (B)(6) 2022, THE PATIENT WAS TRANSFERRED BACK TO CTIICU FOR WORSENING RV DYSFUNCTION, THE LOW FLOW ALARMS RECURRED. ON (B)(6) 2022, THE PATIENT WAS WEANED OFF DBA AND REMAINS ON MILRINONE WITH ATTEMPTED SLOW WEAN. NO ADDITIONAL INFORMATION PROVIDED. NO ADDITIONAL INFORMATION PROVIDED.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION REPORTED THAT THE PATIENT HAD A PLEURAL EFFUSION. ON (B)(6) 2022 COMPUTED TOMOGRAPHY (CT) OF THE CHEST ANGIOGRAM REVEALED A LARGE LOCULATED LEFT-SIDED PLEURAL EFFUSION AND MODERATE RIGHT PLEURAL EFFUSION WITH ADJACENT AIRSPACE OPACITIES, LIKELY ATELECTASIS. HOWEVER, THE PATIENT DEVELOPED PNEUMONIA WITH A START DATE OF (B)(6) 2022. INCIDENTAL ACUTE PULMONARY EMBOLUS IN RIGHT UPPER LOBE SEGMENTAL PULMONARY ARTERY BRANCH. A COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) SHOWED PE (NO PUMP THROMBUS) ALREADY ON HEPARIN DROPS FOR PUMP ACTIVATED FACTOR GOAL 0.2-0.3. REGARDING THE RIGHT HEART FAILURE, ADDITIONAL INFORMATION REPORTED THAT THE PATIENT WAS SLOW WEANED OFF MILRINONE ON (B)(6) 2022. ON SIDENAFIL, MILRINONE WAS RESTARTED ON (B)(6) 2022 AT 0.2 MCG. PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) LINE INSERTED ON (B)(6) 20222. ELEVATED ASPARTATE AMINOTRANSFERASE (AST) ON (B)(6) 2022 POST IMPLANT RETURNED TO NORMAL LIMIT BY (B)(6) 2022. HEPATIC FUNCTION UP TRENDING (B)(6) 2022 TO (B)(6) 2022. GAMMA-GLUTAMYL TRANSFERASE (GGT) 118 ON (B)(6) 2022 WITH A CONTINUOUS RISE IN AST AND ALANINE TRANSAMINASE (ALT). ON (B)(6) 2022 AST 142, ALT 84. ON (B)(6) 2022, RIGHT HEART FAILURE REPORTED IN WHICH THE PATIENT REMAINS ON 0.25 MCG OF MILRINONE. IT WAS ALSO REPOSTED THAT THE PATIENT CONTINUED TO HAVE LOW FLOW ALARMS BEGINNING (B)(6) 2022. THE PATIENT WAS CHANGED TO LOW FLOW CONTROLLER ON (B)(6) 2022 AND GIVEN FLUDROCORTISONE 0.1 MG TO PROMOTE FLUID RETENTION IN SETTING OF ONGOING LOW FLOW ALARMS. THE PATIENT WAS ALSO COVID POSITIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    766858 HEARTMATE 3 LVAS IMPLANT KIT VENTRICULAR (ASSISST) BYPASS DSQ THORATEC CORPORATION 106524US 8253022 00813024013297

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Female Required Intervention| H| O