BEUDAMED
    FDA Adverse Event Death Summary report: N

    THORATEC® HEARTMATE 3® LVAS IMPLANT KIT

    MDR report key: 21433033 · Received February 21, 2025

    Report

    Report Number
    2916596-2025-01181
    Event Type
    Death
    Date Received
    February 21, 2025
    Date of Event
    October 1, 2023
    Report Date
    March 25, 2025
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013297
    PMA / PMN Number
    P160054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTIONS A AND D: SPECIFIC PATIENT INFORMATION AND DEVICE SERIAL NUMBER ARE DOCUMENTED AS UNKNOWN. DETAILS ARE LISTED IN THE ATTACHED ARTICLE. DEVICE WAS IMPLANTED AT TIME OF EVENT. SECTION B2: SPECIFIC DEATH DATE IS DOCUMENTED AS UNKNOWN. DETAILS ARE LISTED IN THE ATTACHED ARTICLE SECTION B3: DATE OF EVENT HAS BEEN ENTERED AS 01OCT2023 AS PATIENTS WERE IMPLANTED BETWEEN NOVEMBER 2014 AND OCTOBER 2023. AUTHOR INFORMATION: VINOGRADSKY, A., HYNDS, M., KAKU, Y., ARNELL, T., POWERS, A., YUZEFPOLSKAYA, M., COLOMBO, P., SAYER, G., URIEL, N., NAKA, Y., & TAKEDA, K. (2024). OMENTAL WRAPPING FOR REFRACTORY DRIVELINE INFECTION AFTER HEARTMATE 3 IMPLANTATION. THE JOURNAL OF HEART AND LUNG TRANSPLANTATION, 43(4), S598¿S599. HTTPS://DOI.ORG/10.1016/J.HEALUN.2024.02.910. BAYLOR SCOTT AND WHITE HEALTH, FORT WORTH, TX. THE REPORTABLE AWARE DATE IS THE DATE THE SJM NOTIFIER COMPLETED READING THE ARTICLE AND ENTERED IN THE COMPLAINT DATABASE (PER SECTION 6.3.4 OF 90979616). NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER¿S INVESTIGATION IS COMPLETED.

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: SECTION E1: REPORTER ESTABLISHMENT NAME CORRECTED. SECTION H6: HEALTH EFFECT - CLINICAL CODE CORRECTED. MANUFACTURER'S INVESTIGATION CONCLUSION: THE PUMP REMAINS IN USE SUPPORTING THE PATIENT. A CORRELATION BETWEEN THE DEVICE AND THE REPORT OF INFECTION COULD NOT BE CONCLUSIVELY DETERMINED. INFECTION IS LISTED IN THE INSTRUCTIONS FOR USE AS A POTENTIAL ADVERSE EVENT THAT MAY BE ASSOCIATED WITH THE USE OF HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM. INFECTION HAS BEEN PREVIOUSLY INVESTIGATED AND WILL CONTINUE TO BE MONITORED THROUGH QUALITY DATA REVIEWS, WHICH ARE CONDUCTED ON PRODUCTION AND POST PRODUCT SIGNALS TO EVALUATE IF PRODUCTS ARE CONFORMING TO PRODUCT REQUIREMENTS. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THROUGH THE RESEARCH ARTICLE "OMENTAL WRAPPING FOR REFRACTORY DRIVELINE INFECTION AFTER HEARTMATE 3 IMPLANTATION" THAT DRIVELINE INFECTIONS (DLI) ARE A FREQUENT COMPLICATION OF LEFT VENTRICULAR ASSIST DEVICE (LVAD) THERAPY AND ACCOUNT FOR SIGNIFICANT MORBIDITY AND MORTALITY. THE STUDY RETROSPECTIVELY REVIEWED PATIENTS WHO UNDERWENT HEARTMATE (HM) 3 IMPLANTATION AT THE INSTITUTION BETWEEN NOVEMBER 2014 AND OCTOBER 2023. DURING THE STUDY PERIOD, 336 HM3 LVADS WERE IMPLANTED AT THE CENTER. FIFTY-FOUR PATIENTS (16.1%) DEVELOPED AT LEAST ONE DLI. OF THESE, 6 (11.1%) UNDERWENT INCISION AND DRAINAGE (I&D) WITH OMENTAL WRAPPING FOR REFRACTORY DLI. MEDIAN AGE OF THE COHORT WAS 57.9 YEARS (RANGE: 45.2, 65.8) AT INTERVENTION. ALL PATIENTS HAD UNDERGONE AT LEAST ONE PREVIOUS I&D FOR DLI FOLLOWED BY VACUUM-ASSISTED WOUND CLOSURE, WITH MEDIAN TIME TO INITIAL DLI OF 2.1 YEARS (RANGE: 0.3, 6.2). TWO HAD A HISTORY OF VARIABLE ADHERENCE TO ANTIBIOTIC THERAPY. MEDIAN TIME FROM HM3 IMPLANTATION TO OMENTAL FLAP WAS 3.6 YEARS (RANGE: 0.4, 6.5). COMPUTED TOMOGRAPHY REVEALED THAT INFECTION HAD EXTENDED CLOSE TO THE PUMP IN ALL PATIENTS; 4 (66.7%) PATIENTS¿ WOUND CULTURES YIELDED POSITIVE RESULTS. INTRAOPERATIVELY, IN ADDITION TO EXTENSIVE I&D, A LAPAROSCOPICALLY HARVESTED OMENTAL FLAP WAS WRAPPED AROUND DRIVELINE. SKIN WAS CLOSED PRIMARILY. THERE WAS ONE DEATH IN A PATIENT WHO HAD LEFT THE HOSPITAL AGAINST MEDICAL ADVICE WITHOUT ANTIBIOTIC THERAPY. HE WAS READMITTED ON POSTOPERATIVE DAY 18 WITH SEVERE SEPSIS SECONDARY TO S. AUREUS BACTEREMIA AND DIED ON DAY 31. THE FIVE REMAINING PATIENTS CONTINUE ON THE HM3 WITH NO EVIDENCE OF DLI RECURRENCE ON CHRONIC ANTIBIOTIC SUPPRESSION AT A MEDIAN OF 2.4 MONTHS (RANGE: 0.0, 3.8) AFTER THE PROCEDURE. THE FOLLOWING DETAILS WERE GIVEN FOR 4/6 PATIENTS WHO UNDERWENT INCISION AND DRAINAGE (I&D) WITH OMENTAL WRAPPING: PATIENT 1: 59 YEAR OLD MALE AT IMPLANT. COMORBIDITIES AND MEDICAL HISTORY: HYPERTENSION, DIABETES MELLITUS, CORONARY ARTERY DISEASE, CEREBROVASCULAR ACCIDENT, PERIPHERAL VASCULAR DISEASE, PRIOR CORONARY ARTERY BYPASS GRAFTING. PREVIOUS DRIVELINE INFECTION 6.2 YEARS AFTER HEARTMATE (HM) 3 IMPLANT, RECURRENCE 6.5 YEARS AFTER HM 3 IMPLANT. CULTURE RESULTS FOR BOTH INSTANCES WERE NEGATIVE WITH RARE POLYMORPHONUCLEAR NEUTROPHILS. INFECTION WAS MANAGED WITH OMENTAL FLAP. SUBJECT FOLLOWED UP 2.9 MONTHS AFTER OMENTAL FLAP AND CURRENT STATUS IS ALIVE ON THE DEVICE. PATIENT 2: 54 YEAR OLD MALE AT IMPLANT. COMORBIDITIES AND MEDICAL HISTORY: HYPERTENSION, SUBMASSIVE PULMONARY EMBOLISM, POLYSUBSTANCE USE DISORDER. PREVIOUS DRIVELINE INFECTION 3.5 YEARS AFTER HEARTMATE (HM) 3 IMPLANT, CULTURES WERE POSITIVE FOR METHICILLIN SENSITIVE STAPHYLOCOCCUS AUREUS (MSSA) WITH VARIABLE ADHERENCE TO ANTIBIOTIC THERAPY. DRIVELINE INFECTION RECURRENCE 4.1 YEARS AFTER HM 3 IMPLANT, CULTURES POSITIVE FOR MSSA AND ENTEROBACTER CLOACAE. INFECTION WAS MANAGED WITH OMENTAL FLAP. SUBJECT FOLLOWED UP 1 MONTH AFTER OMENTAL FLAP AND CURRENT STATUS IS DECEASED. PATIENT 3: 41 YEAR OLD MALE AT IMPLANT. COMORBIDITIES AND MEDICAL HISTORY: CEREBROVASCULAR ACCIDENT, ATRIAL FIBRILLATION, IMPLANTABLE CARDIAC DEFIBRILLATOR, POLYSUBSTANCE USE DISORDER, HISTORY OF POOR ADHERENCE PREVENTING LISTING FOR TRANSPLANT. PATIENT HAD 2 PREVIOUS DRIVELINE INFECTIONS 1.6 YEARS AFTER IMPLANT WITH CULTURES POSITIVE FOR S. EPIDERMIDIS. DRIVELINE INFECTION RECURRENCE 4 YEARS AFTER IMPLANT, CULTURES WERE POSITIVE FOR MORGANELLA MORGANIL. INFECTION WAS MANAGED WITH OMENTAL FLAP. SUBJECT FOLLOWED UP 4 MONTHS AFTER OMENTAL FLAP AND CURRENT STATUS IS ALIVE ON THE DEVICE. PATIENT 4: 57 YEAR OLD MALE AT IMPLANT. COMORBIDITIES AND MEDICAL HISTORY: HYPERTENSION, HYPERLIPIDEMIA, DIABETES MELLITUS, CEREBROVASCULAR ACCIDENT, IMPLANTABLE CARDIAC DEFIBRILLATOR. PATIENT HAD 3 PREVIOUS DRIVELINE INFECTIONS. THE FIRST WAS 2.2 YEARS AFTER IMPLANT AND CULTURES WERE POSITIVE FOR P. AERUGINOSA. THE SECOND WAS 2.7 YEARS AFTER IMPLANT AND CULTURES WERE POSITIVE FOR A. XYLOSOXIDANS. THE THIRD WAS 3.1 YEARS AFTER IMPLANT AND CULTURES WERE POSITIVE FOR P. AERUGINOSA AND CANDIDA ORTHOPSILOSIS. THERE WAS VARIABLE ADHERENCE TO ANTIBIOTIC THERAPY. DRIVELINE INFECTION RECURRENCE 3.3 YEARS AFTER IMPLANT, CULTURES WERE NEGATIVE WITH RARE POLYMORPHONUCLEAR NEUTROPHILS. INFECTION WAS MANAGED WITH OMENTAL FLAP. SUBJECT FOLLOWED UP 3.3 MONTHS AFTER OMENTAL FLAP AND CURRENT STATUS IS ALIVE ON THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1472671 THORATEC® HEARTMATE 3® LVAS IMPLANT KIT VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106524US 00813024013297

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death