HEARTMATE 3 LVAS IMPLANT KIT
Report
- Report Number
- 2916596-2025-00930
- Event Type
- Death
- Date Received
- February 25, 2025
- Date of Event
- August 1, 2024
- Report Date
- March 25, 2025
- Manufacturer
- THORATEC CORPORATION
- Product Code
- DSQ
- PMA / PMN Number
- P160054
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
SECTION A, D: SPECIFIC PATIENT INFORMATION AND DEVICE SERIAL NUMBER ARE DOCUMENTED AS UNKNOWN. SECTION B3: DATE OF EVENT HAS BEEN ENTERED AS THE SAME AS PUBLISHED DATE SINCE DATE OF DATA COLLECTION WAS NOT PROVIDED TITLE: 25 YEARS OF LEFT VENTRICULAR ASSIST DEVICES IN PERTH BAUMWOL, J., SILBERT, B., SHAH, A., DEMBO, L., HAYES, H., MCLEAN, J., & LARBALESTIER, R. (2024). 25 YEARS OF LEFT VENTRICULAR ASSIST DEVICES IN PERTH. HEART LUNG AND CIRCULATION, 33, S242. HTTPS://DOI.ORG/10.1016/J.HLC.2024.06.244 NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE THE MANUFACTURER¿S INVESTIGATION IS COMPLETE.
SECTION D1: BRAND NAME CORRECTED. SECTION D4: MODEL NUMBER AND CATALOG NUMBER CORRECTED. SECTION E: REPORTER INFORMATION CORRECTED. SECTION G2: REPORT SOURCE CORRECTED. MANUFACTURER¿S INVESTIGATION CONCLUSION: A DIRECT CORRELATION BETWEEN THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS) AND THE REPORTED PATIENT OUTCOMES COULD NOT BE CONCLUSIVELY ESTABLISHED THROUGH THIS EVALUATION. NO PRODUCT WAS EVALUATED UNDER THIS COMPLAINT. THE HEARTMATE 3 DEVICE SERIAL NUMBERS, AS WELL AS OTHER SPECIFIC CASE/PATIENT INFORMATION, ARE NOT AVAILABLE. A REVIEW OF THE RELEVANT SECTIONS OF THE DEVICE HISTORY RECORDS COULD NOT BE PERFORMED AS THE SERIAL NUMBER OF THE DEVICE WAS NOT COMMUNICATED/IDENTIFIED. THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS) INSTRUCTIONS FOR USE (IFU), REV. C IS CURRENTLY AVAILABLE. SECTION 1 OF THE IFU, ¿INTRODUCTION,¿ LISTS POTENTIAL ADVERSE EVENTS, INCLUDING DEATH, THAT MAY BE ASSOCIATED WITH THE USE OF THE HEARTMATE 3 LVAS. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.
IT WAS REPORTED THROUGH THE RESEARCH ARTICLE "25 YEARS OF LEFT VENTRICULAR ASSIST DEVICES IN PERTH" THAT HEARTMATE 3 MAY BE ASSOCIATED WITH INFECTION, GASTROINTESTINAL BLEEDING, STROKE, AND DEATH. THE STUDY REVIEWED THE OUTCOMES OF THE WESTERN AUSTRALIAN LVAD PROGRAM. 158 LEFT VENTRICULAR ASSIST DEVICES (LVADS) HAVE BEEN IMPLANTED IN 25 YEARS, OF WHICH 106 WERE NEWER GENERATION DEVICES (INCLUDING HEARTMATE 3). ALMOST ALL PATIENTS (92%) WERE CLASSED AS BRIDGE-TO-TRANSPLANT OR -CANDIDACY/DECISION, WITH THE REMAINDER CLASSED ¿DESTINATION THERAPY¿ (DT). MEAN LV EJECTION FRACTION WAS 20% AND 33% HAD SEVERE RIGHT VENTRICULAR DYSFUNCTION. SIXTY-THREE PERCENT OF PATIENTS HAD A NON-ISCHAEMIC CARDIOMYOPATHY. FOLLOWING LVAD IMPLANT THE MEDIAN LENGTH OF STAY IN INTENSIVE CARE WAS 2 DAYS, AND IN HOSPITAL OVERALL 23 DAYS. NINETY-SIX PERCENT SURVIVED TO HOSPITAL DISCHARGE, AND FOLLOWING DISCHARGE 97% OF DAYS WITH LVAD WERE SPENT AS AN OUTPATIENT. THE MEDIAN NUMBER OF HOSPITAL READMISSIONS WAS 1.6 PER PATIENT PER YEAR. LVAD-ASSOCIATED INFECTION REQUIRING ADMISSION OR INTRAVENOUS ANTIBIOTICS AT ANY TIME POST-IMPLANT OCCURRED IN 36%, SIGNIFICANT GASTROINTESTINAL BLEEDING IN 19%, AND STROKE IN 9%. THE PERCENTAGE OF PATIENTS ALIVE WITH LVAD STILL IN SITU AT 1, 2, AND 5 YEARS WAS 92%, 88%, AND 68%, RESPECTIVELY. ALL DT PATIENTS SURVIVED AT LEAST 4 YEARS, SPENDING 97% OF DAYS WITH LVAD AS AN OUTPATIENT, AND FOUR DT PATIENTS HAVE SURVIVED FOR AT LEAST 10 YEARS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1088345 | HEARTMATE 3 LVAS IMPLANT KIT | VENTRICULAR (ASSIST) BYPASS | DSQ | THORATEC CORPORATION | 106524INT |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Death |