BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THORATEC® HEARTMATE 3® LVAS IMPLANT KIT

    MDR report key: 19722420 · Received July 11, 2024

    Report

    Report Number
    2916596-2024-04247
    Event Type
    Injury
    Date Received
    July 11, 2024
    Date of Event
    December 1, 2023
    Report Date
    July 15, 2024
    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
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A1-A6: SPECIFIC PATIENT INFORMATION AND DEVICE SERIAL NUMBER WAS NOT PROVIDED AND ARE DOCUMENTED AS UNKNOWN. B3: DATE OF EVENT IS APPROXIMATE AS THE DATA WERE COLLECTED BETWEEN JAN2010 AND DEC2023. B5: BYRNE, R.D H.P. TUNUGUNTLA H.P, CHOUDHRY S, ADACHI, I, HICKEY, E.J, BROD, A: BAYLOR COLLEGE OF MEDICINE/ TEXAS CHILDREN'S HOSPITAL, HOUSTON, TX; FRANKEL, W.C: CLEVELAND CLINIC, CLEVELAND, OH NAIR A.P, CIVITELLO, A.: TEXAS HEART INSTITUTE, HOUSTON, TX. JOURNAL OF HEART AND LUNG TRANSPLANTATION, SUPPL. SUPPLEMENT 43.4: S499. ELSEVIER INC. (APR 2024). D4: DEVICE SERIAL NUMBER AND LOT NUMBER WERE NOT PROVIDED, AND EXPIRATION DATE AND MANUFACTURE DATE (H4) CANNOT BE DETERMINED. THE PRIMARY UDI NUMBER IN D4 IS REFLECTIVE OF ALL AVAILABLE INFORMATION. NO FURTHER INFORMATION PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE THE MANUFACTURER INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: A SPECIFIC CAUSE FOR THE REPORTED DRIVELINE INFECTION COULD NOT BE CONCLUSIVELY DETERMINED THROUGH THIS EVALUATION. THE STUDY PERFORMED A RETROSPECTIVE REVIEW OF PATIENTS WITH CONGENITAL HEART DISEASE THAT WERE AGE 18 OR OLDER AT THE TIME OF VENTRICULAR ASSIST DEVICE (VAD) IMPLANT FROM 2010-2023. THREE OF THE PATIENTS INCLUDED IN THE STUDY WERE IMPLANTED WITH A HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS). ONE PATIENT WITH A HEARTMATE 3 LVAS EXPERIENCED A DRIVELINE INFECTION APPROXIMATELY 1.5 YEARS AFTER IMPLANT OF THE VAD. AT THE CONCLUSION OF THE STUDY PERIOD, THE THREE PATIENTS WITH HEARTMATE 3 LVAS DEVICES REMAINED ON VAD SUPPORT. SPECIFIC DEVICE SERIAL NUMBERS WERE NOT PROVIDED, AND NO PRODUCT WAS AVAILABLE FOR EVALUATION. THE HEARTMATE 3 LVAS INSTRUCTIONS FOR USE (IFU) LISTS DRIVELINE INFECTION AS AN ADVERSE EVENT THAT MAY BE ASSOCIATED WITH THE USE OF THE HEARTMATE 3 LVAS. ADDITIONALLY, THE HEARTMATE 3 LVAS IFU AND PATIENT HANDBOOK BOTH PROVIDE INFORMATION REGARDING HOW TO PREVENT INFECTION. THE APPLICABLE SERIAL/LOT NUMBER OF THE HEARTMATE 3 LVAD (LEFT VENTRICULAR ASSIST DEVICE) ASSOCIATED WITH THE REPORTED EVENT WAS NOT PROVIDED AND WAS UNABLE TO BE IDENTIFIED THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS) INSTRUCTIONS FOR USE (IFU), REV. C IS CURRENTLY AVAILABLE. SECTION 1 ¿INTRODUCTION¿ OF THIS DOCUMENT LISTS DRIVELINE INFECTION AS AN ADVERSE EVENT THAT MAY BE ASSOCIATED WITH THE USE OF THE HEARTMATE 3 LVAS. ADDITIONALLY, SECTION 6 ¿PATIENT CARE AND MANAGEMENT¿ LISTS INFECTION AS A POTENTIAL LATE POSTIMPLANT COMPLICATION THAT MAY BE ASSOCIATED WITH THE USE OF THE HEARTMATE 3 LVAS. THIS SECTION INCLUDES INFORMATION FOR CARING FOR THE DRIVELINE EXIT SITE AS WELL AS INFORMATION REGARDING HOW TO PREVENT AND CONTROL INFECTION. THE HEARTMATE 3 LVAS PATIENT HANDBOOK REV. D, CONTAINS SEVERAL SECTIONS WITH INFORMATION ABOUT HOW TO PREVENT AND CONTROL INFECTION AS WELL AS INFORMATION FOR CARING FOR THE DRIVELINE EXIT SITE. 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 ¿MEDIUM TO LONG-TERM VENTRICULAR ASSIST DEVICE SUPPORT IN ADULTS WITH CONGENITAL HEART DISEASE: THE BAYLOR ST. LUKE'S MEDICAL CENTER / TEXAS CHILDREN'S HOSPITAL EXPERIENCE¿ THAT THE HEARTMATE 3 LEFT VENTRICULAR ASSIST LVAD) MAY BE RELATED TO INFECTION. A RETROSPECTIVE REVIEW OF PATIENTS WITH CONGENITAL HEART DISEASE AGE 18 OR OLDER AT TIME OF VAD IMPLANTATION FROM 2010-2023 WAS PERFORMED. IMPLANTED DEVICES INCLUDED HEARTMATE II, HVAD, AND HEARTMATE 3. ONLY 2 PATIENTS DID NOT EXPERIENCE DEVICE-RELATED COMPLICATIONS DURING FOLLOW-UP. OF THE 3 HEARTMATE 3 PATIENTS, COMPLICATIONS INCLUDED DRIVELINE INFECTION (33%). MEDIUM TO LONG-TERM VAD SUPPORT IN ADULT CONGENITAL HEART DISEASE (ACHD) PATIENTS IS POSSIBLE, INCLUDING FOR PATIENTS WITH FONTAN CIRCULATION. DEVICE-RELATED COMPLICATIONS MAY BE LESS FREQUENT IN PATIENTS SUPPORTED WITH THE HEARTMATE 3.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2346591 THORATEC® HEARTMATE 3® LVAS IMPLANT KIT VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106524US 00813024013297

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization| R