BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THORATEC® HEARTMATE 3® LVAS IMPLANT KIT

    MDR report key: 21434592 · Received February 21, 2025

    Report

    Report Number
    2916596-2025-00920
    Event Type
    Injury
    Date Received
    February 21, 2025
    Date of Event
    January 1, 2013
    Report Date
    February 21, 2025
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013297
    PMA / PMN Number
    P160054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    SPECIFIC PATIENT INFORMATION AND DEVICE SERIAL NUMBER ARE DOCUMENTED AS UNKNOWN. DEPARTMENT OF INTERNAL MEDICINE, UNIVERSITY OF MICHIGAN, 1500 E MEDICAL CENTER DRIVE TC 311Q, ANN ARBOR, MI 48109-5853, USA. DIVISION OF CARDIOVASCULAR MEDICINE, UNIVERSITY OF MICHIGAN MEDICAL CENTER, ANN ARBOR, MI 48109-5869, USA . ELECTROPHYSIOLOGY SECTION, DIVISION OF CARDIOVASCULAR MEDICINE, UNIVERSITY OF MICHIGAN, 1425 E. ANN ST. FLOOR 3 RECEPTION C, ANN ARBOR, MI 48103, USA. DEPARTMENT OF CARDIOVASCULAR SURGERY, UNIVERSITY OF MICHIGAN, ANN ARBOR, MI 48103, USA. CURTIS, B., DESHMUKH, A., LARSON, J., GHANBARI, H., GHANNAM, M., CRAWFORD, T., LATCHAMSETTY, R., PAGANI, F., BOGUN, F., & LIANG, J. (2024). SAFETY AND HEMODYNAMIC IMPLICATIONS OF TRANSSEPTAL ACCESS FOR VENTRICULAR TACHYCARDIA ABLATION IN PATIENTS WITH LEFT VENTRICULAR ASSIST DEVICES. JOURNAL OF INTERVENTIONAL CARDIAC ELECTROPHYSIOLOGY, 67(6), P.1319-1321. HTTPS://DOI.ORG/10.1007/S10840-024-01768-0. MANUFACTURER¿S INVESTIGATION CONCLUSION: A DIRECT CORRELATION BETWEEN HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEMS (LVAS) AND THE REPORTED EVENTS COULD NOT CONCLUSIVELY BE ESTABLISHED THROUGH THIS EVALUATION. THE SERIAL NUMBERS OF THE HEARTMATE 3 LEFT VENTRICULAR SYSTEMS IN USE WERE NOT PROVIDED. THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS) INSTRUCTIONS FOR USE (IFU), REVISION D IS CURRENTLY AVAILABLE. SECTION 1 OF THIS DOCUMENT LISTS ADVERSE EVENTS, INCLUDING CARDIAC ARRYTHMIA AND RIGHT HEART FAILURE, THAT MAY BE ASSOCIATED WITH THE USE OF THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM. SECTION 6 ¿PATIENT CARE AND MANAGEMENT¿ LISTS ARRHYTHMIA AS A POTENTIAL LATE POSTIMPLANT COMPLICATIONS THAT MAY BE ASSOCIATED WITH THE USE OF HEARTMATE 3 LVAS. ADDITIONALLY, SECTION 6, ¿PATIENT CARE AND MANAGEMENT¿, EXPLAINS THAT POST-IMPLANTATION HYPERTENSION MAY BE TREATED AT THE DISCRETION OF THE ATTENDING PHYSICIAN. 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." 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 ¿SAFETY AND HEMODYNAMIC IMPLICATIONS OF TRANSSEPTAL ACCESS FOR VENTRICULAR TACHYCARDIA ABLATION IN PATIENTS WITH LEFT VENTRICULAR ASSIST DEVICES¿ THAT THE HEARTMATE 3 (HM3) MAY BE ASSOCIATED WITH VENTRICULAR TACHYCARDIA, VENTRICULAR ANEURYSM, PULMONARY HYPERTENSION, MODERATE OR SEVERE RIGHT VENTRICLE DYSFUNCTION, TRANSPLANTATION, AND DEATH. A TOTAL OF 15 PATIENTS WITH LVAD UNDERWENT 19 VENTRICULAR TACHYCARDIA ABLATION PROCEDURES WITH SINGLE TRANSSEPTAL ACCESS FOR LEFT VENTRICLE (LV) ABLATION WITHOUT ATRIAL SEPTAL DEFECT (ASD) CLOSURE. LVADS INCLUDED HEARTMATE 3 AND HEARTWARE HVAD. 6 HAD PULMONARY HYPERTENSION, AND 7 HAD MODERATE OR SEVERE RIGHT VENTRICLE DYSFUNCTION. POST-PROCEDURE ECHOCARDIOGRAMS (N = 14; MEDIAN TIME TO ECHO 57 DAYS) SHOWED NO INTRACARDIAC SHUNTING OR PERSISTENT ASD. RIGHT HEART CATHETERIZATION (RHC) (PRE: N = 14; POST: N = 8, AT MEDIAN FOLLOW-UP 92.5 DAYS) SHOWED SIMILAR PRE-AND POST-ABLATION RA PRESSURES (11.5 VS. 12 MMHG, P = 0.17) AND WEDGE PRESSURES (20.5 VS. 19.5 MMHG, P = 0.99). SIGNIFICANT SHUNTING WAS ABSENT ON PRE- VERSUS POST-ABLATION ARTERIAL (MEDIAN 95% VS. 99%) AND PA OXYGEN SATURATIONS (58% VS. 62%). NO CLINICALLY SIGNIFICANT RIGHT-LEFT SHUNTING OR HYPOXIA/HYPOXEMIA OCCURRED POST-ABLATION. OVER MEAN FOLLOW-UP OF 581 ± 418 DAYS AFTER LAST ABLATION, 10 PATIENTS REMAINED ALIVE, 1 OF WHOM UNDERWENT HEART TRANSPLANTATION. 5 PATIENTS DIED DURING FOLLOW-UP (4 FROM CONDITIONS UNRELATED TO ABLATION AND 1 FROM RECURRENT VT). AT 1 YEAR AFTER LAST ABLATION, VA RECURRED IN 5 (30%) PATIENTS (FIG. 1A).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1109626 THORATEC® HEARTMATE 3® LVAS IMPLANT KIT Ventricular (assist) bypass DSQ THORATEC CORPORATION 106524US 00813024013297

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Life Threatening| R