BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE 3 LVAS IMPLANT KIT

    MDR report key: 11656599 · Received April 13, 2021

    Report

    Report Number
    2916596-2021-01723
    Event Type
    Injury
    Date Received
    April 13, 2021
    Date of Event
    March 13, 2021
    Report Date
    June 18, 2021
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013297
    PMA / PMN Number
    P160054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: A DIRECT CORRELATION BETWEEN HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM, SERIAL NUMBER (B)(6), AND THE REPORTED EVENTS (INFECTION, RIGHT HEART FAILURE, RENAL DYSFUNCTION, CARDIAC ARRHYTHMIA, WOUND DEHISCENCE, HYPERTENSION, AND PATIENT CONDITION) CANNOT BE CONCLUSIVELY DETERMINED THROUGH THIS INVESTIGATION. THE PATIENT REMAINS ONGOING ON HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM, SERIAL NUMBER (B)(6). THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM INSTRUCTIONS FOR USE, REV. C, CONTAINS THE FOLLOWING INFORMATION: SECTION 1 LISTS INFECTION, WOUND DEHISCENCE, RIGHT HEART FAILURE, CARDIAC ARRHYTHMIA, HYPERTENSION, AND RENAL DYSFUNCTION AS ADVERSE EVENTS THAT MAY BE ASSOCIATED WITH THE USE OF HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM. SECTION 6 LISTS CARDIAC ARRHYTHMIA AND INFECTION AS POTENTIAL LATE POST-IMPLANT COMPLICATIONS THAT MAY BE ASSOCIATED WITH THE USE OF HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM. ADDITIONALLY, THIS SECTION STATES: "RIGHT HEART FAILURE CAN OCCUR FOLLOWING IMPLANTATION OF THE PUMP. RIGHT VENTRICULAR DYSFUNCTION, ESPECIALLY WHEN COMBINED WITH ELEVATED PULMONARY VASCULAR RESISTANCE, MAY LIMIT THE EFFECTIVENESS OF THE LEFT VENTRICULAR ASSIST SYSTEM DUE TO REDUCED FILLING OF THE PUMP." CARE INSTRUCTIONS REGARDING PREVENTING INFECTION ARE PROVIDED IN VARIOUS SECTIONS OF THIS DOCUMENT. THE RELEVANT SECTIONS OF THE DEVICE HISTORY RECORDS WERE REVIEWED AND SHOWED NO DEVIATION FROM MANUFACTURING OR QUALITY ASSURANCE SPECIFICATIONS. THE IMPLANT KIT SHIPPED ON (B)(6) 2021. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ON (B)(6) 2021, PATIENT DEPRESSION WAS WORSENING. ON (B)(6) 2021, PROGRESS NOTE FIRST MENTIONED ACUTE KIDNEY INJURY (AKI) AND 1 LITER OF FLUIDS WAS GIVEN. PATIENT HAD POOR ORAL INTAKE AND WAS VOIDING WELL. THE PATIENT EXPERIENCED ANOREXIA BEGINNING (B)(6) 2021. WEIGHT WAS: 78.1 KG ((B)(6) 2021), 76 KG ((B)(6) 2021), 77.2 KG ((B)(6)2021), 74.2 KG ((B)(6)2021). ON (B)(6)2021, KEFLEX WAS COMPLETED. ON (B)(6)2021, THE PATIENT WAS MORE COOPERATIVE WITH THERAPY AND WALKED 275 FEET WITH CARE GIVER. THE PATIENT REMAINED MORE NON VERBAL THEN PRE-OPERATION AND WOULD CHOOSE TO REMAIN IN BED. ON (B)(6) 2021, THE PATIENT DEFERRED PHYSICAL THERAPY BUT HAD OCCUPATIONAL THERAPY IN BED. ON (B)(6) 2021, THE PATIENT WAS COOPERATIVE WITH OCCUPATIONAL THERAPY AND DID PHYSICAL THERAPY ONE TIME ON (B)(6)2021 BUT DID NOT WANT TO GET OUT OF BED ON (B)(6)2021. ON (B)(6)2021, THERE WAS NO DRAINAGE RELATED TO INFECTION NOTED. ON (B)(6)2021, HEART FAILURE TEAM WAS CONSULTED FOR DEHYDRATION AND ELECTROLYTE MANAGEMENT. SPECIFICALLY HYPONATREMIA DIUERTICS WERE STOPPED AND NORMAL SALINE (NS) 250 CC WAS GIVEN INTRAVENOUSLY. FREE WATER INTAKE WAS LIMITED TO 1000 CC. URINE SODIUM (NA) WAS LOW, CONSISTENT WITH DEHYDRATION. ACETAZOLAMIDE WAS STOPPED AND NA RANGED 123-130 MEQ/DAY SINCE ADMISSION, MAY BE AN ELEMENT OF CHRONIC HYPONATREMIA MADE WORSE BY DEHYDRATION. THE PATIENT WAS ASYMPTOMATIC. TOLVAPTAN WAS GIVEN ONCE ON (B)(6)2021 AND ON (B)(6)2021, THE PATIENT APPEARED EUVOLEMIC AND DIURETICS WERE CONTINUED TO BE HELD. ON (B)(6)2021, THE PATIENT WAS HOLDING BASELINE CREATININE RANGE AND RENAL DYSFUNCTION RESOLVED TO BASELINE RENAL INSUFFICIENCY. POOR APPETITE CONTINUED ON (B)(6)2021 AND NUTRITION WAS FOLLOWING CLOSELY. PATIENT WAS MORE TALKATIVE AND DEPRESSIVE MOOD WAS IMPROVING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED RIGHT HEART FAILURE STARTING ON (B)(6) 2021 POST OPERATIVE PRESSURES AND INOTROPES WERE REQUIRED, FOLLOWING THEIR HEARTMATE IMPLANT OPERATION. THE PATIENT REQUIRED TREATMENT WITH VASOPRESSORS AND INOTROPES. THE PATIENT WAS GIVEN DOBUTAMINE 5 MCG/KG/MIN, EPINEPHRINE 0.08 MCG/KG/MIN, AND MILRINONE 0.25 MCG/KG/MIN. AFTER BEING EXTUBATED ON (B)(6) 2021, THE PATIENT DEVELOPED A SUPRAVENTRICULAR TACHYCARDIA AT 160-171 BPM WITH SUBSEQUENT HYPOTENSION BUT CENTRAL VENOUS PRESSURE (CVP) AND MEAN ARTERIAL PRESSURE (MAP) REMAINED UNCHANGED. THE PATIENT WAS TREATED WITH CARDIOVERSION AT 150J ONCE AND 200J ONCE WITH A BRIEF CONVERSION TO SINUS RHYTHM. THE PATIENT WAS GIVEN 100MG LIDOCAINE BOLUS WITH NO RESPONSE, THEN 2 AMIODARONE BOLUSES AND INFUSION. NORMAL SINUS RHYTHM WAS RESTORED AFTER THE SECOND BOLUS OF AMIODARONE. EPINEPHRINE WAS WEANED OFF ON (B)(6) 2021. THE PATIENT WAS STARTED ON NICARDIPINE ON (B)(6) 2021 AND TITRATED TO A MAP LESS THAN 90 MMHG, DOWN FROM A PRESSURE OF 96 MMHG. ON (B)(6) 2021 THE PATIENT WAS ALSO ON DOBUTAMINE 5MCG/KG/MIN AND MILRINONE 0.13 MCG/KG/MIN. THE PATIENT WAS STABLE WITH CVP 8 MMHG AND MEAN PULMONARY ARTERY (PA) PRESSURE AT 23 MMHG. DOBUTAMINE WAS STOPPED ON (B)(6) 2021. AMIODARONE DRIP WAS WEANED AND ADMINISTERED ORALLY ON (B)(6) 2021 AND THE DRIP WAS DISCONTINUED ON (B)(6) 2021. ON (B)(6) 2021 THE PATIENT WAS OFF MILRINONE. ON (B)(6) 2021 NICARDIPINE STOPPED AND MAP WAS 87 MMHG. ON (B)(6) 2021, THE SITE ANTICIPATED THE NEED FOR POST OPERATIVE REHAB OR HOME HEALTH SERVICES DUE TO DECONDITIONING DESPITE ROUTINE THERAPY IN HOSPITAL. ON (B)(6) 2021 THERE WAS A SMALL STERNAL SURGICAL WOUND DEHISCENCE WITH MINIMAL PURULENT DRAINAGE NOTED DISTAL STERNOTOMY. KEFLEX 500MG FOR 7 DAYS STARTED. THE PATIENT WAS ADVISED TO PAINT INCISION WITH BETADINE ONCE A DAY. ON (B)(6) 2021 THE WOUND WAS LESS PURULENT WITH LESS DRAINAGE. THE PATIENT ALSO EXPERIENCED CARDIOGENIC SHOCK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    554371 HEARTMATE 3 LVAS IMPLANT KIT VENTRICULAR (ASSISST) BYPASS DSQ THORATEC CORPORATION 106524US 7824810 00813024013297

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Hospitalization| R