BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE II LVAS IMPLANT KIT (WITH SEALED GRAFTS)

    MDR report key: 16576439 · Received March 20, 2023

    Report

    Report Number
    2916596-2023-01453
    Event Type
    Malfunction
    Date Received
    March 20, 2023
    Date of Event
    March 2, 2023
    Report Date
    June 29, 2023
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024011224
    PMA / PMN Number
    P060040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    RELATED MFR # FOR THE PREVIOUS DRIVELINE REPAIR: 2916596-2022-01697 SECTION D9, H3: A PORTION OF THE PERCUTANEOUS LEAD WAS RETURNED. MANUFACTURER'S INVESTIGATION CONCLUSION INCIDENTAL FINDINGS 1. DAMAGE TO THE BLACK AND GRAY SHRINK TUBING AS WELL AS THE COPPER TAPE WAS OBSERVED AT THE PREVIOUS DRIVELINE REPAIR SITE. 2. FLUID INGRESS WAS OBSERVED AT THE PREVIOUS DRIVELINE REPAIR SITE. REVIEW OF THE SUBMITTED LOG FILE CONFIRMED LOW SPEED AND PUMP STOP EVENTS ON (B)(6) 2023 WHILE THE PATIENT WAS CONNECTED TO 14 VOLT (V) BATTERY POWER. ALTHOUGH THE EVALUATION OF THE REPLACED EXTERNAL PORTION OF THE DRIVELINE (DL) AND THE SUBMITTED IMAGES DID NOT CONFIRM AN ISSUE THAT COULD HAVE CONTRIBUTED TO THESE EVENTS, BASED ON PREVIOUS COMPLAINT HISTORY, THE ABNORMAL PUMP OPERATION CAPTURED IN THE SUBMITTED LOG FILE APPEARED TO BE CONSISTENT WITH POTENTIAL DRIVELINE WIRE COMPROMISE. THE REPORTED DAMAGE TO THE OUTER JACKET OF THE PATIENT¿S DL WAS CONFIRMED; HOWEVER, A SPECIFIC CAUSE FOR THE OBSERVED DAMAGE COULD NOT BE CONCLUSIVELY DETERMINED. A DISTAL-END DRIVELINE REPLACEMENT WAS PERFORMED (B)(6) 2023 AND APPROXIMATELY 20¿ OF THE EXTERNAL PORTION/DISTAL-END OF THE DRIVELINE WAS RETURNED FOR EVALUATION. ELECTRICAL CONTINUITY TESTING OF THE RETURNED DRIVELINE WAS CONDUCTED, AND ALL WIRES WERE FOUND TO BE ELECTRICALLY INTACT. NO WIRE-TO-WIRE OR WIRE-TO-SHIELD ELECTRICAL SHORTS WERE INDUCED DURING THIS TEST, DESPITE MANIPULATION OF THE DRIVELINE. LAYERS OF TAPE WERE OBSERVED ALONG THE LENGTH OF THE DRIVELINE, AND UPON REMOVAL OF THE TAPE, DAMAGE TO THE SILICONE JACKET WAS OBSERVED APPROXIMATELY 3¿, 4¿, AND 13" FROM THE METAL CONNECTOR. THE SILICONE JACKET, BIONATE COVER, AND METAL BRAIDED SHIELD LAYERS WERE CAREFULLY REMOVED TO EXAMINE THE UNDERLYING DRIVELINE WIRES. VISUAL INSPECTION OF THE WIRES REVEALED NO EVIDENCE OF ANY BREACHES OR DAMAGE TO THE WIRE INSULATION OR UNDERLYING CONDUCTORS THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENTS. THE DRIVELINE WAS THEN SUBMERGED IN A SALINE BATH FOR HIGH POTENTIAL TESTING TO VERIFY THE INTEGRITY OF EACH WIRE¿S INSULATION. THE TEST DID NOT REVEAL ANY CURRENT LEAKAGE IN THE INSULATION OF ANY OF THE DRIVELINE WIRES. THE ACCOUNT REPORTED THAT THE REPAIR DID NOT RESOLVE THE ISSUE, AND THE PATIENT WAS PLACED ON AN UNGROUNDED PATIENT CABLE. THE PATIENT REMAINS ONGOING ON HEARTMATE II LVAS, SERIAL NUMBER (B)(6), AND NO FURTHER RELATED EVENTS HAVE BEEN REPORTED AT THIS TIME. THE HEARTMATE II LVAS IFU, REV. C, AND THE HEARTMATE II PATIENT HANDBOOK, REV. C ARE CURRENTLY AVAILABLE. SECTIONS 6 AND 8 OF THE HMII IFU, AS WELL AS SECTIONS 4 AND 6 OF THE HMII PATIENT HANDBOOK, PROVIDE INFORMATION REGARDING HOW TO CARE FOR THE DRIVELINE AND ADDRESS DAMAGE DUE TO WEAR AND FATIGUE OF THE DRIVELINE. THESE DOCUMENTS INSTRUCT THE USER TO CHECK THEIR DRIVELINE DAILY FOR SIGNS OF DAMAGE, SUCH AS CUTS, HOLES, OR TEARS. THE PATIENT HANDBOOK ALSO INSTRUCTS THE USER TO CALL THEIR HOSPITAL CONTACT RIGHT AWAY IF THE DRIVELINE IS DAMAGED (OR MIGHT BE DAMAGED). THESE SECTIONS STATE THAT DESPITE CARE, ALL HEARTMATE II DRIVELINES HAVE THE POTENTIAL FOR WIRE/SHIELD BREAKDOWN TO OCCUR DEPENDENT ON DURATION OF USE AND MOVEMENT/FLEXING OVER TIME. ADDITIONALLY, THESE SECTIONS OUTLINE INDICATIONS OF DRIVELINE DAMAGE AS WELL AS THE HOW TO RESPOND TO SUCH EVENTS. SECTION 7 OF THE IFU AND SECTION 5 OF THE HMII PATIENT HANDBOOK ADDRESS ALL HAZARD AND ADVISORY ALARMS, AS WELL AS HOW TO RESPOND TO EACH ALARM CONDITION. THE PATIENT HANDBOOK ALSO CONTAINS A SECTION ON HANDLING EMERGENCIES AND FURTHER INSTRUCTS THE USER TO CALL THEIR HOSPITAL CONTACT IF THE PATIENT THINKS THAT, FOR ANY REASON, ANY PORTION OF THEIR EQUIPMENT IS NOT FUNCTIONING AS USUAL, IS BROKEN, OR THEY ARE UNCOMFORTABLE WITH THE OPERATION OF THE EQUIPMENT. THE IFU AND THE PATIENT HANDBOOK STATE THAT ALTHOUGH THE EXTERNAL COMPONENTS OF THE HEARTMATE II LVAS ARE MOISTURE-RESISTANT, THEY ARE NOT WATERPROOF. THESE DOCUMENTS INSTRUCT THE USER TO TAKE CARE TO PROTECT EXTERNAL SYSTEM COMPONENTS FROM WATER OR MOISTURE¿OUTSIDE IN HEAVY RAIN OR SNOW, AND ALWAYS FOR EVERY SHOWER. THESE DOCUMENTS FURTHER STATE TO NEVER SUBMERGE THE DRIVELINE OR OTHER SYSTEM COMPONENTS IN WATER OR LIQUID. ADDITIONALLY, THE REPLACED HEARTMATE II LVAD PERCUTANEOUS LEAD PATIENT INSTRUCTIONS, REV. D, PROVIDES CARE INSTRUCTIONS AND IMPORTANT PRECAUTIONS REGARDING REPLACED DRIVELINES. THIS DOCUMENT CAUTIONS THE USER: DO NOT KINK OR BEND THE DRIVELINE. CHECK YOUR DRIVELINE OFTEN TO MAKE SURE IT IS FREE OF KINKS OR SHARP BENDS. A KINK OR SHARP BEND IN THE DRIVELINE MAY DAMAGE THE WIRES INSIDE." AND "ALLOW FOR A GENTLE CURVE FOR YOUR DRIVELINE. DO NOT SEVERELY BEND YOUR DRIVELINE MULTIPLE TIMES OR WRAP IT TIGHTLY." THIS IFU STATES TO CHECK YOUR ENTIRE DRIVELINE (INCLUDING THE SPLICED AREA) FOR SIGNS OF DAMAGE (CUTS, HOLES, TEARS). IF YOU DISCOVER DAMAGE TO YOUR DRIVELINE, REPORT IT IMMEDIATELY TO YOUR HOSPITAL CONTACT PERSON. THIS DOCUMENT ALSO NOTES TO PAY SPECIFIC ATTENTION TO THE ¿END¿ AREAS OF THE SPLICE WHERE THE GREY TUBE MEETS THE WHITE TUBE (BOTH ENDS). THE RELEVANT SECTIONS OF THE DEVICE HISTORY RECORDS FOR (B)(6) AND THE DRIVELINES, SERIAL NUMBERS (B)(6), WERE REVIEWED AND SHOWED NO DEVIATIONS FROM MANUFACTURING OR QUALITY ASSURANCE SPECIFICATIONS. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT'S LOG FILES WERE SUBMITTED FOR REVIEW OVER CONCERNS ABOUT PUMP STOPS. A REVIEW OF THE LOG FILE REVEALED LOW FLOW AND POWER CABLE DISCONNECT ALARMS AND PUMP STOPS 4 TIMES ON (B)(6) 2023. THE PATENT'S DRIVELINE HAD EXTENSIVE DAMAGE WITH MOST OF IT COVERED IN RESCUE TAPE. THE PATIENT HAD NO KNOWN RECENT TRAUMA TO THE DRIVELINE. THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR CLOSE OBSERVATION AND IN ORDER TO OBTAIN THE NECESSARY X-RAYS. THE PATIENT HAD A DRIVELINE REVISION ON (B)(6) 2023. NO ALARMS OR UNUSUAL EVENTS WERE SEEN AFTER THE REPAIR. ADDITIONAL INFORMATION REVEALED THAT THE REPAIR DID NOT RESOLVED THE ISSUE

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    823977 HEARTMATE II LVAS IMPLANT KIT (WITH SEALED GRAFTS) VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106015 00813024011224

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Male