BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP

    MDR report key: 16264787 · Received January 30, 2023

    Report

    Report Number
    3007042319-2023-00266
    Event Type
    Injury
    Date Received
    January 30, 2023
    Date of Event
    December 17, 2021
    Report Date
    January 30, 2023
    Manufacturer
    HEARTWARE, INC.
    Product Code
    DSQ
    PMA / PMN Number
    P100047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS INFORMATION IS BASED ENTIRELY ON JOURNAL LITERATURE. MEDTRONIC WAS MADE AWARE OF THIS EVENT THROUGH A SEARCH OF LITERATURE PUBLICATIONS. THIS EVENT OCCURRED OUTSIDE THE US. PATIENT INFORMATION IS LIMITED DUE TO CONFIDENTIALITY CONCERNS. THE EVENT ONLY OCCURRED WITH ONE PATIENT BUT SPECIFIC DETAILS ON THE PATIENT WERE NOT PROVIDED. THE MODEL LISTED IN THE REPORT IS A REPRESENTATIVE OF THE MODEL FAMILY, AS THERE IS NO SPECIFIC MODEL LISTED. WITHOUT A LOT NUMBER OR DEVICE SERIAL NUMBER, THE MANUFACTURING DATE CANNOT BE DETERMINED. SINCE NO DEVICE ID WAS PROVIDED, IT IS UNKNOWN IF THIS EVENT HAS BEEN PREVIOUSLY REPORTED. A REQUEST FOR ADDITIONAL INFORMATION WILL BE MADE AND UPON RECEIPT A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY. REFERENCED ARTICLE: FIBRIN SEALANT PATCH FOR THE MANAGEMENT OF INTRACTABLE BLEEDING FROM AN LVAD APEX CANNULA. THE HEART SURGERY FORUM. 2021. 24(6):E1052-E1053. DOI: 10.1532/HSF.4081. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    A JOURNAL ARTICLE WAS REVIEWED THAT CONTAINED INFORMATION REGARDING THE MANAGEMENT OF BLEEDING FROM A LEFT VENTRICULAR ASSIST DEVICE (LVAD) APEX CANNULA. THE ARTICLE REPORTS A PATIENT IMPLANTED WITH AN LVAD WHO ALSO HAD CONCOMITANT TRICUSPID VALVE RECONSTRUCTION, AN IMPLANT FOR TEMPORARY RIGHT VENTRICULAR SUPPORT VIA RIGHT FEMORAL VEIN, AND AN EIGHT-MILLIMETER VASCULAR GRAFT ANASTOMOSED TO THE CENTRAL PULMONARY ARTERY. BLEEDING OCCURRED FROM THE APEX INFLOW CANNULA SITE WHICH NECESSITATED INTRAOPERATIVE TRANSFUSION OF SIX UNITS OF PACKED RED BLOOD CELLS, FOUR FRESH-FROZEN PLASMAS, FOUR UNITS OF PLATELETS, AND TWO GRAMS OF FIBRINOGEN. HEMOSTASIS COULD NOT BE ACHIEVED DESPITE TWO REVISIONS, ALONG WITH SURGICAL MEASURES SUCH AS ADDITIONAL SUTURING, PLEDGETED SUTURES, FIBRIN SEALANTS, AND OTHER POLYMERIC SEALING DEVICES. FINALLY, A FIBRIN SEALANT PATCH WAS USED AROUND THE APEX CANNULA AND THE BLEEDING CEASED, AND THE PATIENT WAS FULLY ANTICOAGULATED WITHOUT FURTHER REVISIONS OR BLOOD TRANSFUSIONS. THE STATUS/DISPOSITION OF THE LVAD APPEARS TO BE STILL IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    5265 HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP VENTRICULAR (ASSISST) BYPASS DSQ HEARTWARE, INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Male Life Threatening| H| R