BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS IMPLANT KIT

    MDR report key: 11770600 · Received May 4, 2021

    Report

    Report Number
    2916596-2021-02185
    Event Type
    Injury
    Date Received
    May 4, 2021
    Date of Event
    April 14, 2021
    Report Date
    October 25, 2021
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024011224
    PMA / PMN Number
    P060040
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: ANALYSIS OF THE SUBMITTED LOG FILES APPEARED TO SHOW THE SYSTEM OPERATING AS INTENDED AND A DIRECT CORRELATION BETWEEN THE REPORTED EVENTS (SUSPECTED OUTFLOW GRAFT OBSTRUCTION, ELEVATED LACTATE DEHYDROGENASE, SUSPECTED THROMBUS, DRIVELINE INFECTION) AND HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM (HMII LVAS), SERIAL NUMBER (B)(6) COULD NOT BE CONCLUSIVELY ESTABLISHED THROUGH THIS EVALUATION. THE REPORTED EVENTS COULD NOT BE CONFIRMED THROUGH THIS EVALUATION. THE SUBMITTED LOG FILES CONTAIN CUMULATIVE DATA FROM (B)(6) 2021 AT 08:11:06 THROUGH (B)(6) 2021 AT 09:07:20. THE FIXED SPEED WAS SET TO 9200 RPM, POWER RANGED FROM 4.8-6.9 W, ESTIMATED FLOW RANGED FROM 3.9-7.7 LPM, AND AVERAGE PI (PULSATILITY INDEX) RANGED FROM 3.0-7.1. NO ABNORMAL TRENDS IN PUMP PARAMETERS WERE OBSERVED. NO ATYPICAL ALARMS WERE CAPTURED THROUGHOUT THE FILE. THE PUMP SPEED REMAINED ABOVE THE LOW SPEED LIMIT FOR THE DURATION OF THE FILES. THE SYSTEM APPEARED TO BE OPERATING AS INTENDED. MULTIPLE REQUESTS FOR ADDITIONAL INFORMATION WERE SENT TO THE CENTER, INCLUDING REQUESTS FOR THE CT SCAN IMAGES; HOWEVER, NO FURTHER DETAILS WERE PROVIDED. THE PATIENT REMAINS ONGOING ON HMII LVAS, SERIAL NUMBER (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 (B)(6) 2009. THE HEARTMATE II LVAS INSTRUCTIONS FOR USE (IFU) REV. C, IS CURRENTLY AVAILABLE. SECTION 1 OF THIS IFU LISTS DRIVELINE INFECTION AND THROMBOSIS AS ADVERSE EVENTS THAT MAY BE ASSOCIATED WITH THE USE OF THE HMII LVAS. CARE INSTRUCTIONS IN REGARDS TO PREVENTING INFECTION ARE OUTLINED IN VARIOUS SECTIONS OF THIS DOCUMENT. SECTION 1 OF THIS IFU PROVIDES AN EXPLANATION OF EACH OF THE PUMP PARAMETERS. SECTION 5 ENTITLED ¿SURGICAL PROCEDURES¿ CONTAINS INFORMATION REGARDING THE PREPARATION AND ATTACHMENT OF THE SEALED OUTFLOW GRAFT. THIS SECTION INSTRUCTS THE USER TO VERIFY THAT THE GRAFT IS NOT TWISTED OR KINKED BY CHECKING THE POSITION OF THE BLACK LINE ON THE GRAFT ABOVE AND BELOW THE BEND RELIEF AND ENSURING THAT THE LINE IS STRAIGHT. THIS SECTION WARNS THAT FAILURE TO CONNECT THE BEND RELIEF SO THAT IT IS FULLY AND EVENLY CONNECTED CAN ALLOW KINKING AND ABRASION OF THE GRAFT, WHICH MAY TO SERIOUS ADVERSE EVENTS SUCH AS LOW LEFT VENTRICULAR ASSIST DEVICE FLOW AND/OR BLEEDING. SECTION 6 ENTITLED ¿PATIENT CARE AND MANAGEMENT¿ PROVIDES INFORMATION REGARDING ANTICOAGULATION THERAPY AND THE RECOMMENDED INR (INTERNATIONAL NORMALIZED RATIO) RANGE. THIS SECTION OUTLINES INDICATIONS OF PUMP THROMBOSIS AS WELL AS HOW TO RESPOND TO SUCH EVENTS. APPENDIX A OF THE IFU STATES, ¿SUBSEQUENT TO REGULATORY APPROVAL AND COMMERCIAL DISTRIBUTION, USERS OF THE HEARTMATE II LVAS HAVE REPORTED SUSPECTED PUMP THROMBOSIS WHEN OBSERVING ELEVATED LACTATE DEHYDROGENASE (LDH) LEVELS, WITH OR WITHOUT CLINICAL SIGNS OF HEMOLYSIS. THIS SECTION ALSO NOTES THAT THERE IS OVERLAP BETWEEN THE SYMPTOMS OF DEVICE THROMBOSIS, HEMOLYSIS DUE TO OTHER REASONS, AND OTHER UNRELATED ADVERSE EVENTS. DEVICE THROMBOSIS CAN ONLY BE CONFIRMED THROUGH DISASSEMBLY AND EXAMINATION OF AN EXPLANTED PUMP. THE HMII LVAS PATIENT HANDBOOK IS ALSO CURRENTLY AVAILABLE. CARE INSTRUCTIONS IN REGARDS TO PREVENTING INFECTION ARE ALSO OUTLINED IN VARIOUS SECTIONS OF THIS DOCUMENT. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PSEUDOMONAS SPECIES, PSEUDOMONAS MOSSELLI WERE FOUND IN CULTURE. SPECIES IDENTIFIED BY MATRIX-ASSISTED LASER DESORPTION/IONIZATION (MALDI-TOF).

    Additional Manufacturer Narrative · 1

    THE REFERENCED (B)(6) 2020 INFECTION IS REPORTED IN MFR. REPORT #2916596-2021-02455.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT CAME INTO THE EMERGENCY DEPARTMENT WITH ABDOMINAL PAIN, DRAINAGE FROM THE DRIVELINE SITE, AND SYMPTOMS OF A DRIVELINE INFECTION. WHILE IN THE EMERGENCY DEPARTMENT, ELEVATED LACTATE DEHYDROGENASE (LDH) AND PLASMA FREE HEMOGLOBIN (PFH) LEVELS WERE MEASURED. HEARTMATE II CONTROLLER CAPTURED NO VAD ALARMS BUT DID SHOW POWER LEVELS 6-7 W AND FLOW RATES 4-6 LPM. IT WAS NOTED THAT THE PATIENT HAD A HISTORY OF ELEVATED LDH LEVELS AT 400-800 U/L AND AN INTERNATIONAL NORMALIZED RATIO (INR) OF 1.8 UPON ADMITTANCE TO THE EMERGENCY DEPARTMENT. THE PATIENT WAS WORKED UP FOR SUSPECTED PUMP THROMBOSIS. IT WAS REPORTED THAT THE PATIENT WAS ADMITTED INTO THE INTENSIVE CARE UNIT (ICU) ON (B)(6) 2021. THE TYPE OF INFECTION HAD NOT BEEN IDENTIFIED, HOWEVER, IT WAS NOTED THAT THE PATIENT HAD A HISTORY OF ENTEROCOCCUS FAECALIS TREATED IN (B)(6) 2020. THE CAUSE OF THE ELEVATED LDH AND PFH WAS IDENTIFIED AS HYPODENSE MATERIAL SURROUNDING THE DISTAL OUTFLOW GRAFT FOUND AND MAY REPRESENT SCAR TISSUE RATHER THAN THROMBUS. NO INTRALUMINAL THROMBUS WAS IDENTIFIED. IT WAS REPORTED THAT THE DEVICE OPERATED AS EXPECTED. NEW CULTURES FROM THE DRIVELINE WOUND SITE WERE COLLECTED. THE PATIENT REMAINS AFEBRILE BUT IS RECEIVING A COURSE OF INTRAVENOUS (IV) ANTIBIOTICS OF VANCOMYCIN AND CEFEPIME. THE PLAN OF ACTION WAS TO KEEP THE PATIENT ON INTEGRELLIN AND HEPARIN INFUSIONS DUE TO ELEVATED LDH/PFH WITH LOW INR. ADDITIONALLY, THE PATIENT WAS HYDRATED WITH NORMAL SALINE IV FLUIDS. THE PATIENT DECLINED TO EXCHANGE THE PUMP IF THE PUMP THROMBOSED AND MADE DO NOT RESUSCITATE(DNR) STATUS LAST WEEKEND. IT WAS REPORTED THAT THE PATIENT RECEIVED A COURSE OF IV ANTIBIOTICS: ANGIOMAX AND INTEGRILIN ON (B)(6) 2021. ON THE (B)(6) 2021 THE PATIENT HAD FLOW READINGS OF 7 LPM, LDH LEVEL OF 1160 U/L, PFH LEVEL OF 30; BASELINE FLOW READING FOR THE PATIENT IS 5-6 LPM. A REVIEW OF THE LOG FILES FROM (B)(6) 2021 11:17 TO (B)(6) 2021 9:07 REVEALS A FEW LOW VOLTAGE ADVISORY ALARMS; THESE WERE DUE TO NORMAL BATTERY DEPLETION. IT WAS NOTED THAT THE PATIENT IS WAITING TOO LONG TO REPLACE THE BATTERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    665201 HEARTMATE II LVAS IMPLANT KIT VENTRICULAR (ASSISST) BYPASS DSQ THORATEC CORPORATION 103695 00813024011224

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Hospitalization| R