BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS IMPLANT KIT (WITH SEALED GRAFTS)

    MDR report key: 11202490 · Received January 20, 2021

    Report

    Report Number
    2916596-2020-06549
    Event Type
    Injury
    Date Received
    January 20, 2021
    Date of Event
    December 23, 2020
    Report Date
    March 10, 2024
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    PMA / PMN Number
    P060040
    Removal / Correction Number
    FA-Q124-HF-1
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: THE EVALUATION OF THE SUBMITTED COMPUTED TOMOGRAPHY (CT) SCANS CONFIRMED THE REPORTED OUTFLOW GRAFT OBSTRUCTION. THE EVALUATION OF THE LOG FILES SUBMITTED BY THE ACCOUNT CONFIRMED THE REPORT OF LOW FLOW ALARMS AND POWER ELEVATIONS. BASED ON COMPLAINT HISTORY AND SIMILARLY REPORTED EVENTS, THE OUTFLOW GRAFT OBSTRUCTION COULD HAVE CONTRIBUTED TO THE LOW FLOW ALARMS AND POWER ELEVATIONS SEEN IN THE LOG FILES; HOWEVER, A SPECIFIC CAUSE FOR THE OUTFLOW GRAFT OBSTRUCTION COULD NOT CONCLUSIVELY BE DETERMINED THROUGH THIS INVESTIGATION. TWO CT SCANS WERE SUBMITTED FOR REVIEW. A LARGE AMOUNT OF TISSUE BUILDUP WAS OBSERVED BETWEEN THE BEND RELIEF AND THE OUTFLOW GRAFT. THE BUILDUP APPEARED LARGE ENOUGH TO RESULT IN THE REPORTED LOW FLOW EVENTS. THE FIRST SUBMITTED LOG FILE CONTAINED DATA FROM (B)(6)2020 09:39:01 THROUGH (B)(6)2020 15:46:14. THREE ELEVATED POWER/FLOW EVENTS WERE CAPTURED ON (B)(6)2020. FIVE LOW FLOW HAZARD EVENTS WERE CAPTURED ON (B)(6)2020 14:11-15, WHEN THE PUMP FLOW DROPPED BELOW THE LOW THRESHOLD OF 2.5LPM. PRIOR TO AND AFTER THESE EVENTS, THE PUMP APPEARED TO FUNCTION AS INTENDED AND NO OTHER UNUSUAL ALARMS OR EVENTS WERE CAPTURED. THE SECOND SUBMITTED LOG FILE CONTAINED DATA FROM (B)(6)2020 15:10:49 THROUGH (B)(6)2020 087:10:36. INTERMITTENT ELEVATED POWER/FLOW EVENTS WERE CAPTURED ON (B)(6)2020. TRANSIENT LOW FLOW HAZARD EVENTS WERE ALSO CAPTURED ON (B)(6)2020, WHEN THE PUMP FLOW DROPPED BELOW THE LOW THRESHOLD OF 2.5LPM. AFTER THE REPORTED OUTFLOW GRAFT REVISION ON (B)(6)2020, THE PUMP OPERATED AS INTENDED, AND NO ATYPICAL EVENTS WERE CAPTURED. THE ACCOUNT REPORTED A SUDDEN DROP IN FLOW AND POWER ON (B)(6)2020 ALONG WITH INTERMITTENT LOW FLOW ALARMS. THE PATIENT WAS IN GOOD CONDITION AND WAS GIVEN INTRAVENOUS (IV) ARGATROBAN. ON (B)(6)2020, THE EXPERIENCED POWER AND FLOW ELEVATIONS. THE CLINIC PERFORMED A CT SCAN WHICH SHOWED AN OCCLUSION OF THE OUTFLOW GRAFT BETWEEN THE BEND RELIEF AND THE GRAFT ITSELF, AND ON (B)(6)2020, THE CLINIC PERFORMED A REVISION OF THE OUTFLOW GRAFT. THE SURGEON FOUND PROTEIN DEPOSITION IN A HIGH AMOUNT WHICH COMPRESSED THE GRAFT ABOVE THE BEND RELIEF. PUMP PARAMETERS WENT BACK TO NORMAL VALUES DIRECTLY AND THE PATIENT WAS TRANSFERRED TO THE INTENSIVE CARE UNIT (ICU) IN STABLE CONDITIONS AND WAS EXTUBATED SHORTLY THEREAFTER. THE PATIENT REMAINS ONGOING ON HEARTMATE II LVAS, SERIAL NUMBER (B)(6). NO PRODUCT IS AVAILABLE FOR INVESTIGATION. HEARTMATE II LVAS IFU, REV. B, 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 4 ENTITLED ¿SYSTEM MONITOR¿ EXPLAINS THAT PUMP FLOW IS ESTIMATED BASED ON PUMP POWER. SECTION 7 ENTITLED ¿ALARMS AND TROUBLESHOOTING¿ OUTLINES ALL SYSTEM CONTROLLER ALARMS, INCLUDING THE LOW FLOW HAZARD ALARM, AND PROVIDES INFORMATION REGARDING HOW TO RESPOND TO AND TROUBLESHOOT THE ALARMS. SECTION 6 ENTITLED ¿PATIENT CARE AND MANAGEMENT¿ PROVIDES INFORMATION REGARDING ANTICOAGULATION THERAPY AND THE RECOMMENDED INR RANGE. HEARTMATE II LVAS PATIENT HANDBOOK, REV. C, SECTION 5 ENTITLED ¿ALARMS AND TROUBLESHOOTING¿ OUTLINES ALL SYSTEM CONTROLLER ALARMS, INCLUDING THE LOW FLOW HAZARD ALARM, AND PROVIDES INFORMATION REGARDING HOW TO RESPOND TO AND TROUBLESHOOT THE ALARMS. THE RELEVANT SECTIONS OF THE DEVICE HISTORY RECORDS FOR (B)(6) WAS REVIEWED AND SHOWED NO DEVIATIONS FROM MANUFACTURING OR QUALITY ASSURANCE SPECIFICATIONS. THE LVAS KIT SHIPPED ON 31JUL2013. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 0

    NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT VISITED THE OUTPATIENT CLINIC DUE TO A SUDDEN DROP IN FLOW AND POWER ON (B)(6) 2020. LOW FLOW ALARMS WERE OCCURRING INTERMITTENTLY. THE PATIENT WAS FEELING FATIGUED AND WAS READMITTED. ON (B)(6) 2020 THE PATIENT EXPERIENCED HIGH FLOWS AND THE PUMP COULD NOT MAINTAIN THE FIXED SPEED. THE CLINIC PERFORMED A CT-SCAN WHICH SHOWED AN OCCLUSION OF THE OUTFLOW GRAFT BETWEEN THE BEND RELIEF AND THE GRAFT. THE MOST OCCLUDED AREA WAS SEEN ABOUT 2 CM FROM THE BEND RELIEF. ON (B)(6) 2020 THE CLINIC PERFORMED A REVISION OF THE OUTFLOW GRAFT. A HIGH AMOUNT OF PROTEIN DEPOSITION WAS FOUND WHICH COMPRESSED THE GRAFT ABOVE THE BEND RELIEF. PROTEIN AND JELLY TISSUE INGROWTH WAS ALSO REMOVED BENEATH THE BEND RELIEF. AFTER SURGERY, THE PUMP PARAMETERS RETURNED TO NORMAL. THE PATIENT WAS TRANSFERRED TO THE INTENSIVE CARE UNIT IN STABLE CONDITION AND WAS EXTUBATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    98585 HEARTMATE II LVAS IMPLANT KIT (WITH SEALED GRAFTS) VENTRICULAR (ASSISST) BYPASS DSQ THORATEC CORPORATION 106016

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization| R