BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS IMPLANT KIT (WITH SEALED GRAFTS)

    MDR report key: 12590074 · Received October 7, 2021

    Report

    Report Number
    2916596-2021-05477
    Event Type
    Injury
    Date Received
    October 7, 2021
    Date of Event
    August 23, 2021
    Report Date
    November 23, 2021
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024011224
    PMA / PMN Number
    P060040
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: A DIRECT RELATIONSHIP BETWEEN THE DEVICE AND THE REPORTED GASTROINTESTINAL (GI) BLEEDING COULD NOT BE CONCLUSIVELY DETERMINED THROUGH THIS EVALUATION. A DIRECT CAUSE FOR THE REPORTED DRIVELINE INFECTION AND BACTEREMIA COULD NOT BE CONCLUSIVELY DETERMINED THROUGH THIS EVALUATION. THE SUBMITTED LOG FILE CONTAINED DATA FROM 28JUL2021 TO 23AUG2021. THE PUMP OPERATED AT OR ABOVE THE LOW SPEED LIMIT FOR THE DURATION OF THE LOG FILE. THERE WERE NO NOTABLE PUMP-RELATED ALARMS, AND THE LOG FILE APPEARED TO SHOW THE SYSTEM OPERATING AS INTENDED. REVIEW OF THE DEVICE HISTORY RECORDS FOR (B)(6) SHOWED NO DEVIATIONS FROM MANUFACTURING OR QUALITY ASSURANCE SPECIFICATIONS. THE HEARTMATE II LVAS IFU, REV. C IS CURRENTLY AVAILABLE. THE IFU LISTS BLEEDING AND INFECTION AS ADVERSE EVENTS THAT MAY BE ASSOCIATED WITH THE USE OF THE HEARTMATE II LVAS. THE PATIENT CARE AND MANAGEMENT SECTION OF THE IFU DISCUSSES ANTICOAGULATION, INCLUDING RECOMMENDED INR VALUES. THE IFU CONTAINS INFORMATION ON CONTROLLING INFECTION IN THE PATIENT CARE AND MANAGEMENT SECTION. THE HMII LVAS IFU CONTAINS INFORMATION REGARDING PUMP SPEED, POWER, FLOW, AND PI. THE IFU EXPLAINS THAT PUMP POWER IS A DIRECT MEASUREMENT OF MOTOR VOLTAGE AND CURRENT; THEREFORE, CHANGES IN PUMP SPEED, FLOW, OR PHYSIOLOGICAL DEMAND CAN AFFECT PUMP POWER. THIS DOCUMENT ALSO DESCRIBES HOW PUMP PERFORMANCE IS SENSITIVE TO CHANGES IN SYSTEMIC VASCULAR RESISTANCE AND LEFT VENTRICULAR FILLING. THE 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 SUDDEN PI CHANGES INCLUDE SUDDEN CHANGES IN THE PATIENT'S VOLUME STATUS, ARRHYTHMIAS, SUDDEN CHANGES IN POWER, AND SUDDEN CHANGES IN PUMP SPEED. HEARTMATE II LVAS PATIENT HANDBOOK, REV. C, SECTION 2 ENTITLED ¿HOW YOUR HEART PUMP WORKS¿ AND SECTION 4 ENTITLED ¿LIVING WITH THE HEARTMATE II¿ OUTLINE CARE INSTRUCTIONS IN REFERENCE TO PREVENTING INFECTION. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED ON 15SEP2021 THAT THE PATIENT HAD BEEN ADMITTED ON (B)(6) 2021 FOR GASTROINTESTINAL BLEEDING. THE PATIENT WAS ANEMIC WITH A HEMOGLOBIN OF 7.2 AND HAD AN ELEVATED WHITE BLOOD CELL (WBC) COUNT OF 20.7. ON 21SEP2021, IT WAS REPORTED THAT AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PERFORMED ON (B)(6) 2021 FOUND EROSIONS IN THE PATIENT'S FUNDUS. MEANWHILE, A COLONOSCOPY REVEALED A SLOWLY OOZING BLEED IN THE PATIENT'S ASCENDING COLON. 3 HEMOCLIPS WERE PLACED. ON (B)(6) 2021, A EGD AND COLONOSCOPY WERE PERFORMED BUT NO BLEEDING SOURCE WAS FOUND. A (B)(6) 2021 CAPSULE ENDOSCOPY WAS PERFORMED, THOUGH INCOMPLETE WITH LIMITED VISUALIZATION. HOWEVER, 3 VERY SMALL ARTERIOVENOUS MALFORMATIONS (AVMS) WERE FOUND IN THE SMALL BOWEL WHICH WERE NOT ACTIVELY BLEEDING. THE PATIENT'S HEMATOCRIT TO HEMOGLOBIN (H:H) RATIO WAS FOUND TO BE STABLE AT THIS TIME, THE PATIENT WAS STARTED ON OCREOTIDE. THE PATIENT ALSO REPORTEDLY HAD BACTEREMIA AND WAS POSITIVE FOR ACINETOBACTER WHICH WAS GROWING IN THEIR DRIVELINE SITE. THE PATIENT REPORTEDLY HAD A CHRONIC DRIVELINE INFECTION. THEY ALSO RECEIVED SOLUMEDROL PRIOR TO BLOOD TRANSFUSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1487454 HEARTMATE II LVAS IMPLANT KIT (WITH SEALED GRAFTS) VENTRICULAR (ASSISST) BYPASS DSQ THORATEC CORPORATION 106015 00813024011224

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Male Hospitalization| R