BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE 3 LVAS IMPLANT KIT

    MDR report key: 12145343 · Received July 9, 2021

    Report

    Report Number
    2916596-2021-03470
    Event Type
    Injury
    Date Received
    July 9, 2021
    Date of Event
    June 10, 2021
    Report Date
    March 13, 2024
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013297
    PMA / PMN Number
    P160054
    Removal / Correction Number
    FA-Q124-HF-1
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    VOLUNTARY MEDWATCH NUMBER 3400300000-2021-0000023 WAS RECEIVED ON 06MAY2022. NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER¿S INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: A SPECIFIC CAUSE FOR THE REPORTED EVENTS, AS WELL AS A DIRECT CORRELATION TO THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM (HM3 LVAS), SERIAL NUMBER (B)(6), COULD NOT CONCLUSIVELY BE DETERMINED. IT WAS REPORTED THAT THE INPATIENT TEAM WAS CONCERNED DUE TO THE CLINICAL DETERIORATION OF THE PATIENT. A REVIEW OF THE SUBMITTED LOG FILES REVEALED THAT THERE WERE NO NOTABLE ALARMS, AND THE PUMP APPEARED TO HAVE OPERATED AS INTENDED AT THE SET SPEED. ADDITIONAL INFORMATION REVEALED THAT THE PATIENT WAS ADMITTED ON (B)(6) 2021 WITH INCREASED SHORTNESS OF BREATH, FATIGUE, AN INTERNATIONAL NORMALIZED RATIO (INR) OF 8.1, LACTATE DEHYDROGENASE (LDH) OF 1023, ASPARTATE AMINOTRANSFERASE (AST) OF 544 AND ALANINE TRANSAMINASE (ALT) OF 452. ON (B)(6) 2021, A COMPUTED TOMOGRAPHY (CT) SCAN SHOWED PERIPHERAL THROMBUS IN THE PROXIMAL LVAD OUTFLOW TRACT (TOWARDS THE PUMP) RESULTING IN UP TO 50% LUMINAL NARROWING WITH NO INDICATION OF OBSTRUCTION OF THE LVAD. ON (B)(6) 2021 THERE WAS A SURGICAL PROCEDURE WHERE THE BEND RELIEF WAS DISSECTED FREE AND INCISED LONGITUDINALLY WITH IMMEDIATE EXTRUSION OF THICK FIBROUS MATERIAL WHICH CAUSED COMPRESSION OF THE OUTFLOW GRAFT. THE BEND RELIEF WAS EXCISED COMPLETELY WITH THE REMAINING GRAFT SITES SEWN TOGETHER. MULTIPLE ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION FROM THE CUSTOMER REGARDING THE EVENT; HOWEVER, NO ADDITIONAL INFORMATION WAS PROVIDED. THE PATIENT REMAINS ONGOING ON HEARTMATE 3 LVAS, SERIAL NUMBER (B)(6). THE DEVICE IS NOT 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 IMPLANT KIT WAS SHIPPED ON (B)(6) 2019. THE HEARTMATE 3 LVAS INSTRUCTIONS FOR USE (IFU), REV. C, AND PATIENT HANDBOOK, REV. D ARE CURRENTLY AVAILABLE. SECTION 1, ¿INTRODUCTION,¿ LISTS POTENTIAL ADVERSE EVENTS, INCLUDING HEMOLYSIS, THAT MAY BE ASSOCIATED WITH THE USE OF HEARTMATE 3 LVAS. THE HM3 LVAS IFU CONTAINS A SECTION ENTITLED ¿PREPARING THE SEALED OUTFLOW GRAFT" AND EXPLAINS HOW TO ATTACH THE SEALED OUTFLOW GRAFT TO THE AORTA. ALSO IN THIS SECTION, "ATTACHING THE SEALED OUTFLOW GRAFT TO THE PUMP," 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. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: THE RELEVANT SECTIONS OF THE DEVICE HISTORY RECORDS FOR (B)(6) WERE REVIEWED AND SHOWED NO DEVIATIONS FROM MANUFACTURING OR QUALITY ASSURANCE SPECIFICATIONS. THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS) INSTRUCTIONS FOR USE (IFU) IS CURRENTLY AVAILABLE. SECTION 1, ¿INTRODUCTION,¿ LISTS ADVERSE EVENTS THAT MAY BE ASSOCIATED WITH THE USE OF HEARTMATE 3 LVAS. A DIRECT CORRELATION BETWEEN HEARTMATE 3 LVAS, SERIAL NUMBER (B)(6), AND THE REPORTED CLINICAL DETERIORATION COULD NOT BE CONCLUSIVELY ESTABLISHED THROUGH THIS EVALUATION. THE SUBMITTED LOG FILES APPEARED TO SHOW THE PUMP OPERATING AS INTENDED. MULTIPLE ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION FROM THE CUSTOMER REGARDING THE EVENT; HOWEVER, NO ADDITIONAL INFORMATION WAS PROVIDED. THE PATIENT REMAINS ONGOING ON HEARTMATE 3 LVAS, SERIAL NUMBER (B)(6) . NO FURTHER RELATED EVENTS HAVE BEEN REPORTED AT THIS TIME. 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 · 0

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT WAS ADMITTED ON 10JUN2021 WITH INCREASED SHORTNESS OF BREATH AND FATIGUE. THE PATIENT HAD AN INTERNATIONAL NORMALIZED RATIO (INR) OR 8.1, A LACTATE DEHYDROGENASE (LDH) OF 1023, AN ASPARTATE AMINOTRANSFERASE (AST) OF 544, AND AN ALANINE AMINOTRANSFERASE (ALT) OF 452. THE PATIENT HAD BEEN TAKING ASPIRIN AND COUMADIN (WARFARIN) AS ORDERED. ON (B)(6) 2021 BIVALIRUDIN WAS STARTED. THE PATIENT'S FLOWS AND POWERS INCREASED AFTER ADMISSION. A COMPUTED TOMOGRAPHY (CT) SCAN DONE ON 15JUN2021 REVEALED 50% NARROWING OF THE OUTFLOW GRAFT. ON (B)(6) 2021 THE PATIENT UNDERWENT A SURGICAL PROCEDURE WHERE THE BEND RELIEF WAS DISSECTED FREE AND INCISED LONGITUDINALLY WITH IMMEDIATE EXTRUSION OF THICK FIBROUS MATERIAL THAT WAS COMPRESSING THE OUTFLOW GRAFT. THE BEND RELIEF WAS EXCISED COMPLETELY WITH THE REMAINING GRAFT SITES SEWN TOGETHER.

    Additional Manufacturer Narrative · 1

    NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE THE MANUFACTURER¿S INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INPATIENT TEAM WAS CONCERNED WITH THE PATIENT'S CLINICAL DETERIORATION. REVIEW OF THE PATIENT'S LOG FILES SHOWED ONE PI EVENT ALONG WITH SET SPEED AND HEMATOCRIT CHANGES. THE PUMP APPEARED TO BE OPERATING AS INTENDED WITH NO OTHER NOTABLE ALARMS OR EVENTS. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1042166 HEARTMATE 3 LVAS IMPLANT KIT VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106524US 7032694 00813024013297

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Male Other| R| H