BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE 3 LVAS IMPLANT KIT

    MDR report key: 13600498 · Received February 25, 2022

    Report

    Report Number
    2916596-2022-00704
    Event Type
    Injury
    Date Received
    February 25, 2022
    Date of Event
    August 18, 2021
    Report Date
    May 4, 2022
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013297
    PMA / PMN Number
    P160054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE PATIENT'S PREVIOUS STENT PLACEMENT RELATED TO OUTFLOW GRAFT OBSTRUCTION IS REPORTED UNDER MFR REPORT # 2916596-2020-05102. NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE THE MANUFACTURER¿S INVESTIGATION IS COMPLETED.

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: THE REPORTED OUTFLOW GRAFT OBSTRUCTION WAS UNABLE TO BE CONFIRMED FROM THIS EVALUATION AS NO PHOTOS DEPICTING THE OBSTRUCTION WERE SUBMITTED FOR REVIEW. MULTIPLE ATTEMPTS TO GATHER ADDITIONAL INFORMATION WERE ATTEMPTED; HOWEVER, NONE WAS PROVIDED. THE PATIENT REMAINS ONGOING ON LEFT VENTRICULAR ASSIST SYSTEM (LVAS), SERIAL NUMBER (B)(6). NO PRODUCT IS AVAILABLE FOR INVESTIGATION. THE RELEVANT SECTIONS OF THE DEVICE HISTORY RECORDS FOR (B)(6) WERE REVIEWED AND SHOWED NO DEVIATIONS FROM MANUFACTURING OR QUALITY ASSURANCE SPECIFICATIONS. THE LVAS KIT WAS SHIPPED ON 04JAN2019. HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS) INSTRUCTIONS FOR USE (IFU) IS CURRENTLY AVAILABLE. THIS IFU CONTAINS INFORMATION REGARDING THE PREPARATION OF THE SEALED OUTFLOW GRAFT IN SECTION 5 ¿SURGICAL PROCEDURES¿. 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 ENSURING THAT THE LINE IS STRAIGHT. THIS SECTION ALSO EXPLAINS THAT WHEN DE-AIRING IS COMPLETED, SLIDE THE BEND RELIEF OVER THE METAL FITTING OF THE SEALED OUTFLOW GRAFT TOWARD THE LOCKING SCREW RING UNTIL IT ENGAGES IN PLACE. 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 LEAD TO SERIOUS ADVERSE EVENTS SUCH AS LOW LEFT VENTRICULAR ASSIST DEVICE FLOW. SECTION 5 ALSO INSTRUCTS THE USER TO STRETCH THE GRAFT COMPLETELY AND THEN MEASURE AND CUT THE SEALED OUTFLOW GRAFT TO THE APPROPRIATE LENGTH UNDER ¿ATTACHING THE SEALED OUTFLOW GRAFT TO THE AORTA.¿ SECTION 1 OF THE HEARTMATE 3 LVAS IFU "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 LPM AND EXPLAINS THAT CHANGES IN PATIENT CONDITIONS CAN RESULT IN LOW FLOW, SUCH AS HYPERTENSION. SECTION 7 ¿ALARMS AND TROUBLESHOOTING¿ DESCRIBES ALL ALARM CONDITIONS, INCLUDING THE LOW FLOW HAZARD ALARM, AS WELL AS THE APPROPRIATE ACTIONS ASSOCIATED WITH THEM. HEARTMATE 3 LVAS PATIENT HANDBOOK IS CURRENTLY AVAILABLE. SECTION 5 "ALARMS AND TROUBLESHOOTING" OUTLINES ALL SYSTEM CONTROLLER ALARMS, INCLUDING THE LOW FLOW HAZARD ALARM, 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. 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 PRESENTED WITH AN OUTFLOW GRAFT (OFG) OBSTRUCTION. THE PATIENT WAS ALSO EXPERIENCING LOW FLOW ALARMS. AN OFG STENT WAS PLACED. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT HAD AN ANGIOPLASTY ON (B)(6) 2021 THAT FOUND A NARROWING OF THE OFG IN A STENTED SEGMENT AT A REGION OF SIGNIFICANT ANGULATION APPROXIMATELY 3.7CM PROXIMAL TO THE AORTIC ANASTOMOSIS. THE NARROWING APPEARED TO BE RELATED TO KINKING OF THE OFG IN THIS SEGMENT, AND APPEARED TO BE LOCATED AT THE SITE OF TWO OVERLAPPING STENTS THAT HAD PREVIOUSLY BEEN PLACED RELATED TO THE OFG OBSTRUCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1680411 HEARTMATE 3 LVAS IMPLANT KIT VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106524US 6773863 00813024013297

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Male Hospitalization| R| O