BEUDAMED
    FDA Adverse Event Death Summary report: N

    THORATEC® HEARTMATE 3® LVAS IMPLANT KIT

    MDR report key: 18231991 · Received November 29, 2023

    Report

    Report Number
    2916596-2023-08015
    Event Type
    Death
    Date Received
    November 29, 2023
    Date of Event
    March 1, 2021
    Report Date
    May 29, 2024
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    PMA / PMN Number
    P160054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: A DIRECT CORRELATION BETWEEN THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEMS (LVAS) AND THE REPORTED PATIENT OUTCOMES COULD NOT CONCLUSIVELY BE ESTABLISHED THROUGH THIS EVALUATION. THE RESEARCH ABSTRACT (SEE ATTACHED) TITLED, ¿COMPARING LONG-TERM SURVIVAL AND READMISSIONS BETWEEN HEARTMATE 3 AND HEART TRANSPLANT AS PRIMARY TREATMENT FOR ADVANCED HEART FAILURE¿, AIMED TO COMPARE 5-YEAR SURVIVAL AND READMISSIONS OF PATIENTS WHO RECEIVED A HEARTMATE 3 (HM3) LEFT VENTRICULAR ASSIST DEVICE (LVAD) OR ORTHOTOPIC HEART TRANSPLANTATION (OHT) AS PRIMARY TREATMENT FOR ADVANCED HEART FAILURE. A TOTAL OF 501 PATIENTS WHO RECEIVED A HM3 IMPLANT OR AN OHT BETWEEN (B)(6) 2014 AND (B)(6) 2021 WERE INITIALLY ANALYZED; HOWEVER, OHT PATIENTS WITH PRIOR LVADS WERE ULTIMATELY EXCLUDED. OF THE SELECTED PATIENTS, 219 RECEIVED A HM3, AND 118 RECEIVED AN OHT. RESULTS SHOWED NO STATISTICAL DIFFERENCE IN 2-YEAR AND 5-YEAR SURVIVAL RATES. HOWEVER, RESULTS DID FIND A GREATER SURVIVAL RATE IN HM3 PATIENTS BETWEEN THE AGES OF 18 AND 58 COMPARED TO HM3 PATIENTS OLDER THAN 59; RESULTS FOR OHT PATIENTS WERE SIMILAR. ADDITIONALLY, THE ALL-CAUSE, UNPLANNED MEAN CUMULATIVE READMISSION AT 5 YEARS WAS SIGNIFICANTLY HIGHER IN THE HM3 PATIENT GROUP. IN CONCLUSION, THE DATA SUGGESTED THAT THE HM3 LVAD PROVIDED COMPARABLE LONG-TERM SURVIVAL TO OHT AS A PRIMARY TREATMENT FOR HEART FAILURE, ESPECIALLY IN YOUNGER PATIENTS, BUT HAD SIGNIFICANTLY INCREASED READMISSIONS. THE HEARTMATE 3 DEVICE SERIAL NUMBERS, AS WELL AS OTHER SPECIFIC CASE/PATIENT INFORMATION, ARE NOT AVAILABLE. THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED AS THE HEARTMATE 3 DEVICE SERIAL NUMBERS, AS WELL AS OTHER SPECIFIC CASE/PATIENT INFORMATION, ARE NOT AVAILABLE. THE HEARTMATE 3 LVAS INSTRUCTIONS FOR USE (IFU), REV. C. IS CURRENTLY AVAILABLE. SECTION 1 OF THIS DOCUMENT LISTS ADVERSE EVENTS THAT MAY BE ASSOCIATED WITH THE USE OF THE HEARTMATE 3 LVAS, INCLUDING DEATH. 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 ONCE THE MANUFACTURER¿S INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 0

    SECTION D1, BRAND NAME: CORRECTED. SECTION D4, CATALOG NUMBER: CORRECTED. SECTION D4, PRIMARY UDI NUMBER: CORRECTED. SECTION 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 WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THROUGH THE RESEARCH ARTICLE ¿COMPARING LONG-TERM SURVIVAL AND READMISSIONS BETWEEN HEARTMATE 3 AND HEART TRANSPLANT AS PRIMARY TREATMENT FOR ADVANCED HEART FAILURE¿ THAT HEARTMATE 3 (HM3) MAY BE ASSOCIATED WITH REQUIRED HOSPITAL READMISSION AND DEATH. THIS RETROSPECTIVE STUDY COMPARED THE SURVIVAL AND READMISSION RATES BETWEEN PATIENTS IMPLANTED WITH HM3 AND PATIENT WHO RECEIVED AN ORTHOTOPIC HEART TRANSPLANT (OHT) AS THEIR PRIMARY RESPECTIVE TREATMENTS FOR ADVANCED HEART FAILURE. A TOTAL OF 501 PATIENTS WHO RECEIVED A HM3 IMPLANT OR AN OHT BETWEEN JAN2014 AND MAR2021 WERE INCLUDED IN THE STUDY; 219 PATIENTS RECEIVED A HM3, AND 119 RECEIVED AN OHT. RESULTS SHOWED NO STATISTICAL DIFFERENCE IN NEITHER THE 2-YEAR (89.6% FOR HM3 VS. 89.7% FOR OHT, P = 0.88) OR 5-YEAR SURVIVAL 967.2% FOR HM3 VS. 84% FOR OHT, P = 0.76) RATES. RESULTS DID FIND A GREATER SURVIVAL RATE IN HM3 PATIENTS BETWEEN THE AGES OF 18 AND 58 COMPARED TO HM3 PATIENTS OLDER THAN 59 (84.7% VS. 58.9%, P = 0.0039); RESULTS FOR OHT PATIENTS WERE SIMILAR. ADDITIONALLY, THE ALL-CAUSE, UNPLANNED MEAN CUMULATIVE READMISSION AT 5 YEARS WAS SIGNIFICANTLY HIGHER IN THE HM3 PATIENT GROUP (5.89 VS 2.99, P < 0.05). 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. DATE OF EVENT IS APPROXIMATE AS THE DATA WAS COLLECTED BETWEEN JAN2014 AND MAR2021.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1771702 THORATEC® HEARTMATE 3® LVAS IMPLANT KIT VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106524US

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death| H