BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE

    MDR report key: 22124859 · Received June 2, 2025

    Report

    Report Number
    2916596-2025-03638
    Event Type
    Injury
    Date Received
    June 2, 2025
    Date of Event
    May 7, 2025
    Report Date
    July 16, 2025
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024011187
    PMA / PMN Number
    P060040
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    MANUFACTURER¿S INVESTIGATION CONCLUSION: REVIEW OF THE SUBMITTED LOG FILE CONFIRMED THE REPORTED PUMP STOP EVENT. ALTHOUGH A SPECIFIC CAUSE COULD NOT BE CONCLUSIVELY DETERMINED AS NO PRODUCT WAS RETURNED FOR EVALUATION, THE ABNORMAL PUMP OPERATION CAPTURED IN THE SUBMITTED LOG FILE APPEARED TO BE CONSISTENT WITH POTENTIAL DRIVELINE WIRE COMPROMISE. THE SUBMITTED LOG FILE CONTAINED EVENTS FROM 06FEB2025 AT 13:49:14 ¿ 07MAY2025 AT 10:39:07, PER THE TIMESTAMPS. A PUMP STOP EVENT WAS CAPTURED ON 05MAY2025 WHILE THE PATIENT WAS CONNECTED TO THE POWER MODULE. ACCORDING TO THE ACCOUNT, THE PATIENT HAD BEEN ON AN UNGROUNDED CABLE AT THE TIME OF THE EVENT. THIS EVENT WAS ASSOCIATED WITH LOW SPEED HAZARD, LOW FLOW HAZARD, AND MOTOR STOP ALARMS. BASED ON PREVIOUS COMPLAINT HISTORY, THE ABNORMAL PUMP OPERATION APPEARS CONSISTENT WITH A POTENTIAL PHASE TO PHASE DRIVELINE ISSUE. NO OTHER NOTABLE EVENTS OR ALARMS WERE CAPTURED. THE PUMP APPEARED TO BE OPERATING AS INTENDED AT THE FIXED SPEED PRIOR TO AND FOLLOWING THE PUMP STOP EVENT. IT WAS REPORTED THAT THE PATIENT'S PUMP WAS OFF FOR ABOUT 2 SECONDS ON 05MAY2025. THEY STATED THEY HAD "BENT THE WRONG WAY" WHEN THIS OCCURRED. THE PATIENT HAD AN EXTERNAL DRIVELINE REPAIR IN 2017 (CS-093204) AND HAS HAD A KNOWN SHORT TO SHIELD ISSUE SINCE 2022 (CS-165819) AND HAS BEEN ON AN UNGROUNDED CABLE EVER SINCE. IT WAS SUSPECTED THAT THE SHORT TO SHIELD HAD MATURED TO A PHASE TO PHASE SHORT. THE PATIENT EXPERIENCED SOME DIZZINESS AT THE TIME OF THE PUMP STOP EVENT. THE PUMP STOP EVENT WAS SAID TO HAVE RESOLVED. THE PATIENT WAS NOT A SURGICAL CANDIDATE AND WAS AT HOME DECIDING WHETHER TO PURSUE PALLIATIVE CARE. THE PATIENT REMAINS ONGOING ON HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM (LVAS), SERIAL NUMBER VAD-51575, WITH NO FURTHER RELATED ISSUES REPORTED AT THIS TIME. THE RELEVANT SECTIONS OF THE DEVICE HISTORY RECORDS FOR VAD-51575 AND DRIVELINE SERIAL NUMBERS 24689 (ORIGINAL) AND 10287 (REPAIR), WERE REVIEWED AND SHOWED NO DEVIATIONS FROM MANUFACTURING OR QUALITY ASSURANCE SPECIFICATIONS. THE HEARTMATE II LVAS INSTRUCTIONS FOR USE (IFU), REV. C, AND THE HEARTMATE II LVAS PATIENT HANDBOOK, REV. C ARE CURRENTLY AVAILABLE. THE CURRENT REVISION OF THE IFU CAN BE FOUND ON THE ELECTRONIC IFU PAGE OF THE ABBOTT WEBSITE. SECTION 6 OF THE IFU ENTITLED "PATIENT CARE AND MANAGEMENT" ADDRESSES HOW TO CARE FOR THE DRIVELINE; HOWEVER, ALL HEARTMATE II DRIVELINES HAVE THE POTENTIAL FOR WIRE/SHIELD BREAKDOWN TO OCCUR DEPENDENT ON DURATION OF USE AND PATIENT HANDLING. IN ADDITION, SECTION 6 (UNDER "PUMP PERFORMANCE MONITORING") OUTLINES INDICATIONS OF DRIVELINE DAMAGE AS WELL AS HOW TO RESPOND TO SUCH EVENTS. SECTION 7 ENTITLED "ALARMS AND TROUBLESHOOTING" OUTLINES ALL SYSTEM CONTROLLER ALARMS AND THE APPROPRIATE ACTIONS ASSOCIATED WITH THEM. THE HEARTMATE II LVAS PATIENT HANDBOOK CONTAINS A SECTION ON ¿CARING FOR THE DRIVELINE.¿ THE SECTION ENTITLED ¿ALARMS AND TROUBLESHOOTING¿ OUTLINES ALL SYSTEM CONTROLLER ALARMS AS WELL AS HOW TO RESPOND TO EACH ALARM CONDITION. A SECTION ON HANDLING EMERGENCIES IS ALSO PROVIDED. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 0

    SECTION D4: EXPIRATION DATE AND MANUFACTURE DATE (H4) CANNOT YET BE DETERMINED. THE PRIMARY UDI NUMBER IN D4 IS REFLECTIVE OF ALL AVAILABLE INFORMATION. SECTION H6: MEDICAL DEVICE PROBLEM CODE CORRECTED. NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT'S PUMP WAS OFF FOR ABOUT 2 SECONDS ON (B)(6) 2025. THEY STATED THEY "BENT THE WRONG WAY" WHEN THIS OCCURRED. LOG FILES WERE SENT FOR REVIEW. THE PATIENT HAD AN EXTERNAL DRIVELINE REPAIR IN 2017 AND DEVELOPED SHORT TO SHIELD IN 2022 AND HAS BEEN ON AN UNGROUNDED CABLE EVER SINCE. IT APPEARED THAT THE SHORT TO SHIELD WAS MATURING TO A PHASE TO PHASE SHORT. THE EVENT OCCURRED WHILE THE PATIENT WAS ON THE PATIENT CABLE.

    Description of Event or Problem · 0

    IT WAS LATER REPORTED THAT THE PATIENT EXPERIENCED SOME DIZZINESS AT THE TIME OF THE PUMP STOP EVENT. THE PUMP STOP EVENT WAS SAID TO HAVE RESOLVED. THE PUMP STOP WAS SUSPECTED TO BE A PREVIOUSLY KNOWN SHORT TO SHIELD THAT HAD DEVELOPED TO A PHASE TO PHASE SHORT. THE PATIENT WAS CURRENTLY AT HOME AND WAS DECIDING WHETHER TO PURSUE PALLIATIVE CARE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    550330 HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 105306 00813024011187

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Female Other