THORATEC® HEARTMATE 3® LVAS IMPLANT KIT

Report

Report Number: 2916596-2026-02284
Event Type: Injury
Date Received: April 27, 2026
Date of Event: December 31, 2024
Report Date: April 27, 2026
Manufacturer: THORATEC CORPORATION
Product Code: DSQ
UDI-DI: 00813024013297
PMA / PMN Number: P160054
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: TX, US
Reporter Occupation: 003

Narratives

Additional Manufacturer Narrative · 0

SECTION A, D: SPECIFIC PATIENT INFORMATION AND DEVICE SERIAL NUMBER ARE DOCUMENTED AS UNKNOWN. DETAILS ARE LISTED IN THE ATTACHED ABSTRACT. DEVICE WAS IMPLANTED AT TIME OF EVENT. SECTION B3: DATE OF EVENT HAS BEEN ENTERED AS THE SAME AS 31DEC2024 SINCE THE DATA WERE COLLECTED BETWEEN 2017 AND 2024. 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. AUTHOR INFORMATION: PICKERING, T., MCCULLOUGH, K. A., DORTON, C. W., RAWITSCHER, D. A., MICHAEL DIMAIO, J., KABRA, N., MILLIGAN, G., RUSIA, A., OGBUE, P., AFZAL, A., & GEORGE, T. J. (2025). PROGNOSTIC VALUE OF THE VASOACTIVE-INOTROPIC SCORE IN PREDICTING OUTCOMES FOLLOWING LVAD IMPLANTATION. JHLT OPEN, 9, 100272. HTTPS://DOI.ORG/10.1016/J.JHLTO.2025.100272 . BAYLOR SCOTT AND WHITE RESEARCH INSTITUTE, BAYLOR SCOTT & WHITE: THE HEART HOSPITAL PLANO, PLANO, TX, DEPARTMENT OF CARDIOLOGY, BAYLOR SCOTT & WHITE: THE HEART HOSPITAL PLANO, PLANO, TX E, DEPARTMENT OF BIOMEDICAL ENGINEERING, TEXAS A&M UNIVERSITY, COLLEGE STATION, TX, DEPARTMENT OF ANESTHESIOLOGY, BAYLOR SCOTT & WHITE: THE HEART HOSPITAL PLANO, PLANO, TX, DEPARTMENT OF CARDIOTHORACIC SURGERY, BAYLOR SCOTT & WHITE: THE HEART HOSPITAL PLANO, PLANO, TX MANUFACTURER'S INVESTIGATION CONCLUSION: A DIRECT CORRELATION BETWEEN THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS) AND THE REPORTED EVENTS 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. THE HEARTMATE 3 LEFT VENTRICULAR ASSIST DEVICE (LVAS) INSTRUCTIONS FOR USE (IFU), REV. D AND THE HEARTMATE 3 PATIENT HANDBOOK, REV. A ARE CURRENTLY AVAILABLE. THE CURRENT REVISION OF IFU AND PATIENT HANDBOOK CAN BE FOUND ON THE EIFU PAGE OF THE ABBOTT WEBSITE. SECTION 1 OF THE IFU, ¿INTRODUCTION¿, LISTS POTENTIAL ADVERSE EVENTS, INCLUDING MULTIPLE TYPES OF ORGAN FAILURE AND DYSFUNCTION (RESPIRATORY FAILURE, RIGHT HEART FAILURE, RENAL FAILURE), AND DEATH, THAT MAY BE ASSOCIATED WITH THE USE OF THE HEARTMATE 3 LVAS. SECTION 6 "PATIENT CARE AND MANAGEMENT" (UNDER "RIGHT HEART FAILURE") DISCUSSES THE POTENTIAL DEVELOPMENT OF RIGHT HEART FAILURE FOLLOWING IMPLANT AND OUTLINES THE ASSOCIATED TREATMENT OPTIONS, INCLUDING INOTROPES AND RIGHT VENTRICULAR ASSIST DEVICE (RVAD) PLACEMENT. SECTION 6 (UNDER CAUTION!) STATES: "RIGHT HEART FAILURE CAN OCCUR FOLLOWING IMPLANTATION OF THE PUMP. RIGHT VENTRICULAR DYSFUNCTION, ESPECIALLY WHEN COMBINED WITH ELEVATED PULMONARY VASCULAR RESISTANCE, MAY LIMIT THE EFFECTIVENESS OF THE LVAS DUE TO REDUCED FILLING OF THE PUMP." THE SERIAL NUMBERS OF THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEMS IN USE WERE NOT PROVIDED. 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 ¿PROGNOSTIC VALUE OF THE VASOACTIVE-INOTROPIC SCORE (VIS) IN PREDICTING OUTCOMES FOLLOWING LVAD IMPLANTATION¿ THAT THE HEARTMATE 3 (HM3) LEFT VENTRICULAR ASSIST DEVICE (LVAD) MAY BE RELATED TO POSTOPERATIVE VASOPLEGIA, THE NEED FOR RVAD OR RENAL REPLACEMENT THERAPY, PROLONGED RESPIRATORY FAILURE REQUIRING TRACHEOSTOMY, AND DEATH. A RETROSPECTIVE REVIEW OF ALL HM3 IMPLANTATIONS FROM 2017 TO 2024 WAS PERFORMED. ALL PATIENTS RECEIVING A DURABLE LVAD WERE INCLUDED, AND LVAD EXCHANGES WERE EXCLUDED. 146 PATIENTS UNDERWENT PRIMARY HEARTMATE 3 LVAD IMPLANTATION. THE MEAN AGE WAS 61.78 ± 12.13 YEARS WITH MALE PREDOMINANCE. THIRTY-FOUR (23.29%) PATIENTS REQUIRED A REDO STERNOTOMY, 54 (36.99%) REQUIRED A CONCOMITANT VALVE PROCEDURE WITH 17 (11.64%) NECESSITATING AORTIC CROSS- CLAMPING. THE MEAN CBP TIME WAS 94.58 ± 32.95 MIN, AND THE MEAN CROSS-CLAMP TIME WAS 22.63 ± 10.10 MIN. FORTY- SEVEN (32.41%) PATIENTS WERE GIVEN HYDROXOCOBALAMIN PRIOR TO CPB, 39 (26.90%) WERE GIVEN METHYLENE BLUE EITHER INTRAOPERATIVELY OR POSTOPERATIVELY AS RESCUE THERAPY, AND 3 (2.05%) PATIENTS RECEIVED BOTH. AN ADDITIONAL 3 (2.05%) PATIENTS RECEIVED ANGIOTENSIN II POSTOPERATIVELY. INITIAL LVAD SPEEDS WERE DETERMINED UTILIZING TRANSESOPHAGEAL ECHOCARDIOGRAPHIC (TEE) GUIDANCE AND RANGED FROM 4800 TO 5300 RPM. LVAD SPEEDS WERE SUBSEQUENTLY TITRATED BASED ON RV FUNCTION AND INVASIVE HEMODYNAMIC MONITORING (SWAN-GANZ CATHETER), WITH SMALL INCREMENTAL INCREASES IN PUMP SPEED (100-200 RPM) OVER THE FIRST 24 HOURS TO OPTIMIZE LEFT-SIDED UNLOADING. POSTOPERATIVE HEMODYNAMIC MANAGEMENT WAS DETERMINED BY A MULTIDISCIPLINARY TEAM. VASOACTIVE MEDICATIONS WERE TITRATED TO ACHIEVE A MEAN ARTERIAL PRESSURE OF 70-90 MMHG, AND INOTROPIC MEDICATIONS WERE TITRATED TO ACHIEVE A CARDIAC INDEX OF 2.1 L/MIN/M². TTE WAS ALSO UTILIZED TO ADJUST LVAD SPEEDS POSTOPERATIVELY. METHYLENE BLUE (2 MG/KG) WAS GIVEN AS A RESCUE THERAPY FOR PATIENTS EXPERIENCING EXTREME VASOPLEGIA. LATER, HYDROXOCOBALAMIN (5 GM/DOSE) WAS USED PROPHYLACTICALLY IN ALL CASES UNTIL THE SUBSEQUENT NATIONAL SHORTAGE PREVENTED CONTINUED USE. POSTOPERATIVE VASOACTIVE MEDICATIONS AND DOSAGES WERE EXTRACTED FROM THE CRITICAL CARE FLOW SHEET AT THE TIME OF ARRIVAL IN THE INTENSIVE CARE UNIT (ICU) AND AT 6, 12, AND 24 HOURS POSTOPERATIVELY. VIS WAS CALCULATED BY USING THE FOLLOWING FORMULA: VIS = DOPAMINE (MCG/KG/MIN) + DOBUTAMINE (MCG/KG/MIN) + 100 X EPINEPHRINE (MCG/KG/MIN) + 100 X NOREPINEPHRINE (MCG/KG/MIN) + 10,000 X VASOPRESSIN (UNITS/KG/MIN) + 10 X MILRINONE (MCG/KG/MIN). IMMEDIATELY POSTOPERATIVELY, PATIENTS REQUIRED A MEDIAN EPINEPHRINE DOSE OF 0.05[0.04-0.08] MCG/KG/MIN, A MEDIAN MILRINONE DOSE OF 0.25[0.00-0.375] MCG/KG/MIN, A MEDIAN DOBUTAMINE DOSE OF 3[0-5] MCG/KG/MIN, A MEDIAN NOREPINEPHRINE DOSE OF 0.00[0.00-0.04] MCG/KG/MIN, AND A MEDIAN VASOPRESSIN DOSE OF 0.02[0.00-0.04] UNITS/MIN. AS EXPECTED, MULTIPLE TITRATIONS OF THESE MEDICATIONS WERE PERFORMED WHILE BEING USED. DOSAGES OF EPINEPHRINE (P < 0.01), NOREPINEPHRINE (P < 0.01), AND VASOPRESSIN (P < 0.01) ALL TENDED TO DECREASE OVER THE FIRST 24 HOURS POSTOPERATIVELY, CONSISTENT WITH ABATING VASODILATION; IN CONTRAST, DOSES OF MILRINONE (P = 0.23) AND DOBUTAMINE (P = 0.72) REMAINED RELATIVELY CONSTANT, CONSISTENT WITH AN ONGOING NEED FOR RV SUPPORT. VASOPRESSOR REQUIREMENTS WERE HIGHLY VARIABLE IN THE IMMEDIATE POSTOPERATIVE PERIOD DUE TO PATIENT AND PROCEDURE SPECIFIC FACTORS, VARIATIONS IN INTRAOPERATIVE HEMODYNAMIC MANAGEMENT STRATEGIES, ANESTHETIC WASHOUT, AND TRANSITION FROM THE OPERATING ROOM TO THE ICU. ACCORDINGLY, THE MEAN VIS DECREASED FROM 16.25 ± 10.04 ON ICU ARRIVAL TO 13.94 ± 8.29 AT 6 HOURS, 11.05 ± 6.60 AT 12 HOURS, AND 9.43 ± 6.30 AT 24 HOURS. THE MEAN VISMAX WAS 18.19 ± 10.14. PATIENTS UNDERGOING RE-OPERATIVE STERNOTOMY HAD A HIGHER VISMAX THAN THOSE UNDERGOING PRIMARY STERNOTOMY (21.40 ± 12.02 VS 17.20 ± 9.3, P = 0.03) AS DID THOSE REQUIRING A CONCOMITANT VALVULAR PROCEDURE (21.14 ± 10.33 VS 16.43 ± 9.66, P < 0.01) AND THOSE REQUIRING RVAD PLACEMENT (24.84 ± 13.00 VS 16.23 ± 8.22, P < 0.01). IN CONTRAST, PATIENTS REQUIRING FULL AORTIC CROSS-CLAMP HAD SIMILAR VISMAX AS THOSE WHO DID NOT (18.14 ± 10.25 VS 18.51 ± 9.50, P = 0.88). THE MAXIMUM VIS (VISMAX) WAS DEFINED AS THE HIGHEST VIS IN THE FIRST 24-HOUR PERIOD. THE PRIMARY OUTCOME OF INTEREST WAS VISMAX, SERVING AS A SURROGATE FOR THE SEVERITY OF POSTOPERATIVE VASOPLEGIA. SECONDARY OUTCOMES INCLUDED 30- DAY (OPERATIVE) AND 1-YEAR SURVIVAL, NEED FOR RVAD OR RENAL REPLACEMENT THERAPY, PROLONGED RESPIRATORY FAILURE REQUIRING TRACHEOSTOMY, AND LENGTH OF ICU AND HOSPITAL STAY. OPERATIVE MORTALITY WAS DEFINED AS DEATH WITHIN 30 DAYS OF SURGERY OR BEFORE DISCHARGE. OVERALL, OPERATIVE MORTALITY WAS 6.85%. PATIENTS WHO SUFFERED AN OPERATIVE MORTALITY HAD HIGHER VISMAX THAN THOSE WHO SURVIVED (25.35 ± 15.93 VS 17.66 ± 9.45, P = 0.02). IN TOTAL, 33 (22.60%) PATIENTS REQUIRED POSTOPERATIVE RVAD SUPPORT, 28 (19.18%) REQUIRED RENAL REPLACEMENT THERAPY, AND 25 (17.12%) REQUIRED A TRACHEOSTOMY. ALTHOUGH THESE COMPLICATIONS MAY REFLECT OVERALL ACUITY, LOGISTIC REGRESSION DEMONSTRATED THAT INCREMENTAL INCREASES IN VISMAX WAS ASSOCIATED WITH RIGHT HEART FAILURE REQUIRING RVAD PLACEMENT (OR: 1.08[1.04,1.13], P < 0.01), POSTOPERATIVE DIALYSIS (OR: 1.08[1.03,1.12], P < ;0.01), AND NEED FOR TRACHEOSTOMY (OR: 1.07[1.03,1.11], P < 0.01). THE STUDY DEMONSTRATED THAT POSTOPERATIVE VASOPLEGIA, AS MEASURED BY THE VISMAX, WAS A SIGNIFICANT PREDICTOR OF BOTH MORBIDITY AND MORTALITY. PATIENTS WITH HIGHER VISMAX HAD A SIGNIFICANTLY INCREASED RISK OF MORTALITY, RV FAILURE REQUIRING RVAD PLACEMENT, POSTOPERATIVE DIALYSIS, PROLONGED RESPIRATORY FAILURE NECESSITATING TRACHEOSTOMY, AND DECREASED 1-YEAR SURVIVAL.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1070841	THORATEC® HEARTMATE 3® LVAS IMPLANT KIT	Ventricular (assist) bypass	DSQ	THORATEC CORPORATION	106524US		00813024013297

Patients

Seq	Age	Sex	Outcome	Treatment
1	NA	Unknown	Hospitalization\| L\| R