BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM

    MDR report key: 8356178 · Received February 20, 2019

    Report

    Report Number
    2916596-2019-00650
    Event Type
    Malfunction
    Date Received
    February 20, 2019
    Date of Event
    February 6, 2019
    Report Date
    May 8, 2019
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013297
    PMA / PMN Number
    P160054
    Removal / Correction Number
    Z-1774-2018
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ABBOTT HAS DECIDED TO INITIATE A VOLUNTARY FIELD ACTION FOR ALL LOT NUMBERS OF HEARTMATE III DISTRIBUTED SINCE (B)(6)2014. INTERNAL INVESTIGATION PERFORMED BY ABBOTT HAS DETERMINED THERE IS A POTENTIAL FOR AN OUTFLOW GRAFT OCCLUSION DUE TO TWISTING. ABBOTT PERFORMED A COMPREHENSIVE INVESTIGATION WHICH INCLUDED DEVICE ANALYSIS, MANUFACTURING EVALUATION AND TREND ANALYSIS. THE ROOT CAUSE IDENTIFICATION DETERMINED THAT BEND RELIEF ROTATION IS INCONSISTENTLY TRANSLATED TO THE OUTFLOW GRAFT HARDWARE. A RISK/BENEFIT ANALYSIS WAS PERFORMED AND IT WAS DETERMINED THAT DESPITE THE POTENTIAL FOR AN OUTFLOW GRAFT OCCLUSION DUE TO TWISTING, THE ASSOCIATED RESIDUAL RISKS ARE LOW AND ARE CONSIDERED ACCEPTABLE. AS A CORRECTIVE ACTION, CONSIGNEES HAVE BEEN NOTIFIED OF THE POTENTIAL OCCLUSION DUE TO TWISTING. ADDITIONALLY, ABBOTT WILL CONTINUE TO TREND COMPLAINTS RELATED TO THIS EVENT BASED ON ORIGINAL EVENT DESCRIPTION AND/OR RESULTS OF PRODUCT EVALUATION. INVESTIGATION SUMMARY: THE REPORT OF AN OUTFLOW GRAFT TWIST COULD NOT BE CONFIRMED THROUGH THIS EVALUATION. ALTHOUGH THE REPORT OF HIGH PI¿S AND LOW FLOW ALARMS WAS CONFIRMED THROUGH THE ANALYSIS OF THE SUBMITTED LOG FILES, A SPECIFIC CAUSE FOR THESE EVENTS COULD NOT BE CONCLUSIVELY DETERMINED THROUGH THIS ANALYSIS. THE CENTER REPORTED THAT THE PATIENT WAS ADMITTED ON (B)(6)2019 WITH CONCERN FOR AN OUTFLOW GRAFT TWIST BASED ON IMAGING. IT WAS REPORTED THAT THE PATIENT HAD HIGH PI¿S AND OCCASIONAL LOW FLOW ALARMS. THE SYSTEM CONTROLLER EVENT LOG FILES CAPTURED 2 TRANSIENT LOW FLOW HAZARD ALARMS ON (B)(6)2019 AT 10:54 AND 11:12. THERE WERE ALSO SEVERAL TRANSIENT CONTROLLER FAULT FLAGS FOR LOW FLOW CAPTURED ON (B)(6)2019 BETWEEN 10:26 AND 11:12. OF NOTE, THESE LOW FLOW EVENTS APPEARED TO BE ASSOCIATED WITH ELEVATED PI (UP TO 11.8). SEVERAL TRANSIENT PI EVENTS WERE ALSO NOTED THROUGHOUT THE LOG FILE, RESULTING IN MOMENTARY DECREASES IN SPEED PER DESIGN. THE PUMP APPEARED TO FUNCTION AS INTENDED. THE PATIENT WAS TRANSPLANTED ON (B)(6)2019 AND IT WAS REPORTED THAT THERE WERE NO DEVICE ISSUES THAT COULD HAVE ACCELERATED THE PATIENT ON THE TRANSPLANT LIST. IT WAS REPORTED THAT NO PRODUCT WOULD BE RETURNED FOR EVALUATION. THE SURGICAL PROCEDURES SECTION OF THE HEARTMATE 3 IFU CONTAINS INFORMATION ON "PREPARING THE SEALED OUTFLOW GRAFT." THE ATTACHING THE SEALED OUTFLOW GRAFT TO THE PUMP 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. THE DE-AIRING THE PUMP SECTION 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. 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. THE HEARTMATE 3 IFU EXPLAINS THAT THE LOW FLOW HAZARD ALARM WILL BE TRIGGERED WHEN PUMP FLOW IS LESS THAN 2.5 LPM AND NOTES THAT CHANGES IN PATIENT CONDITIONS CAN RESULT IN LOW FLOW. THE ALARMS AND TROUBLESHOOTING SECTION EXPLAINS ALL SYSTEM ALARMS, INCLUDING LOW FLOW ALARMS, AND THE RECOMMENDED ACTIONS ASSOCIATED WITH THEM. PUMP PARAMETERS, INCLUDING PULSATILITY INDEX (PI), ARE DETAILED IN THE INTRODUCTION OF THE HM3 IFU. THE HM 3 IFU STATES THAT IF THE SYSTEM DETECTS A PI EVENT, THE PUMP SPEED WILL AUTOMATICALLY REDUCE TO THE LOW SPEED LIMIT AND SLOWLY RAMP BACK UP. PI EVENTS ARE ASSUMED BY THE SYSTEM DURING CASES WHERE THERE IS A SUDDEN AND SUBSTANTIAL CHANGE IN PI. SOME REASONS FOR PI CHANGES INCLUDE SUDDEN CHANGES IN THE PATIENT¿S VOLUME STATUS, ARRHYTHMIAS, SUDDEN CHANGES IN POWER, AND SUDDEN CHANGES IN PUMP SPEED. THE REPORTED EVENT AND SUBSEQUENT INVESTIGATION DO NOT INDICATE AN ISSUE WITH THE MANUFACTURE OF THE PRODUCT. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THE EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THROUGH PATIENT OUTCOME THAT THE PATIENT WAS TRANSPLANTED ON (B)(6) 2019. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT PROVIDED.

    Additional Manufacturer Narrative · 1

    APPROXIMATE AGE OF DEVICE - 1 YEAR, 2 MONTHS. THE PATIENT REMAINS ONGOING WITH THE LVAD DEVICE. NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    THE PATIENT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD) ON (B)(6) 2017. IT WAS REPORTED THAT THE PATIENT HAD A SUSPECTED OUTFLOW GRAFT TWIST. LOG FILE REVIEW FOUND NO UNUSUAL EVENTS AND NO TRENDING SUSPECT OF AN OUTFLOW GRAFT TWIST. HOWEVER UPON TECHNICAL SERVICE REVIEWING THE SUBMITTED IMAGES BELIEVED THAT PATIENT HAD AN OUTFLOW GRAFT TWIST. ON (B)(6) 2019 IT WAS REPORTED LOG FILES SENT FOR REVIEW ON PATIENT JLW. IMAGING CONSISTENT WITH OUTFLOW GRAFT TWIST. NOW WITH HIGH PIS AND OCCASIONAL LOW FLOW ALARMS. HM3 LOG FILES REVIEWED BY TECH SERVICES. NOTED LOW FLOW ALARMS TAKING PLACE ON (B)(6) 2019 10:54:22 AND (B)(6) 2019 11:12:05. PLEASE CONSIDER ANY CONDITIONS WHICH WOULD REDUCE VOLUME SEEN BY THE PUMP. THE GRAPHS SHOW FLOW LOWER AT TIMES WHEN PI IS ELEVATED. THIS OVERALL TREND COULD BE CAUSED BY A PRESSURE OR VOLUME ISSUE. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    148900 HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM LEFT VENTRICULAR ASSIST SYSTEM DSQ THORATEC CORPORATION 106524US 6183444 00813024013297

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention