BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM

    MDR report key: 16781464 · Received April 20, 2023

    Report

    Report Number
    2916596-2023-01908
    Event Type
    Injury
    Date Received
    April 20, 2023
    Date of Event
    March 7, 2023
    Report Date
    March 10, 2024
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013297
    PMA / PMN Number
    P160054
    Removal / Correction Number
    FA-Q124-HF-1
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    SECTIONS A AND D: SPECIFIC PATIENT INFORMATION AND DEVICE SERIAL NUMBER ARE DOCUMENTED AS UNKNOWN. DEVICE WAS IMPLANTED AT TIME OF EVENT. DATE OF EVENT HAS BEEN ENTERED AS THE SAME AS PUBLISHED DATE 07MAR2023 SINCE DATE OF DATA COLLECTION WAS NOT PROVIDED. THE REPORTABLE AWARE DATE IS THE DATE THE SJM NOTIFIER COMPLETED READING THE ARTICLE AND ENTERED IN THE COMPLAINT DATABASE. TITLE: CATHETER-BASED INTERVENTION IN A HM3 WITH EXTRINSIC OUTFLOW GRAFT OBSTRUCTION AND HYPOTENSION HOFELD, B., GAGLIANELLO, N. A., & AZZAM, I. K. JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY. MANUFACTURER'S INVESTIGATION CONCLUSION: EVALUATION OF THE COMPUTED TOMOGRAPHY (CT) SCAN IMAGE IN THE RESEARCH ARTICLE TITLED ¿CATHETER-BASED INTERVENTION IN A HM3 WITH EXTRINSIC OUTFLOW GRAFT OBSTRUCTION AND HYPOTENSION¿ CONFIRMED A DARK AREA ALONG THE OUTFLOW GRAFT THAT APPEARED CONSISTENT WITH AN EXTRINSIC OUTFLOW GRAFT OBSTRUCTION. THE HEARTMATE 3 DEVICE SERIAL NUMBER AND OTHER SPECIFIC CASE/PATIENT INFORMATION IS NOT AVAILABLE AND WAS NOT REQUESTED. NO PRODUCT WAS EVALUATED UNDER THIS COMPLAINT. THE SERIAL NUMBER OR OTHER IDENTIFYING INFORMATION OF THE PRODUCT WAS NOT REPORTED AND WAS NOT ABLE TO BE DETERMINED DURING THE INVESTIGATION. THE CURRENT VERSION OF THE HEARTMATE 3 LVAS IFU CONTAINS A SECTION ENTITLED ¿PREPARING THE SEALED OUTFLOW GRAFT" AND EXPLAINS HOW TO ATTACH THE SEALED OUTFLOW GRAFT TO THE AORTA. ALSO IN THIS SECTION, "ATTACHING THE SEALED OUTFLOW GRAFT TO THE PUMP," INSTRUCTS THE USER TO VERIFY THAT THE GRAFT IS NOT TWISTED OR KINKED BY CHECKING THE POSITION OF THE BLACK LINE ON THE GRAFT ABOVE AND BELOW THE BEND RELIEF AND ENSURING THAT THE LINE IS STRAIGHT. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 0

    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 ¿CATHETER-BASED INTERVENTION IN A HM3 WITH EXTRINSIC OUTFLOW GRAFT OBSTRUCTION AND HYPOTENSION¿ THAT LEFT VENTRICULAR ASSIST DEVICE (LVAD) OUTFLOW GRAFT OBSTRUCTION (OGO) FROM EXTRINSIC, FIBRO-THROMBOTIC COMPRESSION, OR INTERNAL THROMBOSIS CAN OBSTRUCT FLOW, CAUSING SYMPTOMATIC HYPOTENSION. THIS WAS A CASE STUDY THAT EVALUATED A PATIENT WITH ISCHEMIC CARDIOMYOPATHY. THE PATIENT HAD A HEARTMATE 3 FOR FIVE YEARS AT THE TIME OF THE EVENT. THE PATIENT PRESENTED WITH SYMPTOMS OF AN ALTERED MENTAL STATUS AND LOW MEAN ARTERIAL PRESSURES (MAPS). THE PUMP SPEED, FLOW, POWER, AND PULSATILITY INDEXES (PIS) WERE ALL STABLE. THERE WERE NO SIGNS OF HEMOLYSIS AND THE PATIENT'S INTERNATIONAL NORMALIZED RATIO WAS FOUND TO BE THERAPEUTIC. AN OUTFLOW GRAFT OBSTRUCTION WAS SUSPECTED. A COMPUTED TOMOGRAPHY ANGIOGRAPHY (CT-A) SHOWED AN ECCENTRIC, HYPODENSE, >50%, PROXIMAL OUTFLOW GRAFT LESION, IDENTIFIED AS INTERNAL THROMBUS. DECISION-MAKING INTRAVASCULAR ULTRASOUND RULED OUT INTERNAL THROMBUS. TWO SELF-EXPANDING STENTS AND 1 COVERED STENT WERE PLACED. ANTIPLATELET MEDICATION WAS GIVEN FOR 1 MONTH AND A REPEAT CT-A CONFIRMED PATENCY. A GRAFTOPLASTY PROCEDURE IMPROVED THE PATIENT'S SYMPTOMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1612741 HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106524 00813024013297

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention