BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP

    MDR report key: 19949979 · Received August 9, 2024

    Report

    Report Number
    3007042319-2024-04282
    Event Type
    Injury
    Date Received
    August 9, 2024
    Date of Event
    August 2, 2019
    Report Date
    September 25, 2024
    Manufacturer
    HEARTWARE, INC.
    Product Code
    DSQ
    UDI-DI
    00888707002639
    PMA / PMN Number
    P100047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION OF THIS EVENT IS PENDING AND A SUPPLEMENTAL REPORT WILL BE SENT UPON ITS COMPLETION. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE 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. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Additional Manufacturer Narrative · 0

    A SUPPLEMENTAL REPORT IS BEING SUBMITTED FOR INVESTIGATION COMPLETION. PRODUCT EVENT SUMMARY: (B)(6) WAS NOT RETURNED FOR EVALUATION. THIS COMPLAINT IS ASSOCIATED WITH A CLINICAL ADVERSE EVENT. A REVIEW OF THE DEVICE HISTORY RECORD WAS NOT PERFORMED AS THE REPORTED EVENT IS NOT RELATED TO A MANUFACTURING OR SERVICING ISSUE. BASED ON THE AVAILABLE INFORMATION, THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. PER THE INSTRUCTIONS FOR USE, RESPIRATORY DYSFUNCTION AND RENAL DYSFUNCTION ARE KNOWN POTENTIAL COMPLICATIONS ASSOCIATED WITH THE IMPLANTATION OF A VAD. BASED ON REVIEW OF PAST ADVERSE EVENTS FOR THIS PATIENT AND THE PATIENT'S REPORTED MEDICAL HISTORY, IT WAS NOTED THAT THE PATIENT HAD A HISTORY OF RENAL DYSFUNCTION AND RESPIRATORY DYSFUNCTION. POSSIBLE CLINICAL FACTORS THAT MAY HAVE CONTRIBUTED TO THIS EVENT INCLUDE THE PATIENT¿S PRE-EXISTING HISTORY AND RELATED COMORBIDITIES, THE PROGRESSION OF THEIR UNDERLYING DISEASE, ISSUES RELATED TO THE THERAPEUTIC USE OF ANTICOAGULANT AND ANTIPLATELET MEDICATIONS AND THE PATIENT'S COMPLEX POST-OPERATIVE COURSE. THERE ARE POSSIBLE PATIENT, PHARMACOLOGICAL AND PROCEDURAL FACTORS THAT MAY HAVE CONTRIBUTED TO THIS EVENT. INVESTIGATION OF THIS EVENT IS COMPLETED AND THE FILE WILL BE CLOSED. IF NEW INFORMATION IS RECEIVED, THE FILE WILL BE RE-OPENED AND A SUPPLEMENTAL WILL BE SUBMITTED. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE 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. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE VENTRICULAR ASSIST DEVICE (VAD) PATIENT WAS ADMITTED TO AN OUTSIDE HOSPITAL FOR FLUID RETENTION AND SHORTNESS OF BREATH. THE PATIENT WAS TRANSFERRED TO THE IMPLANTING CENTER FOR CONTINUING CARE. AT THE OUTSIDE FACILITY THE PATIENT RE-STARTED HEMODIALYSIS AND HAD A PERM-A-CATH IMPLANTED AS DIALYSIS HAD BEEN UTILIZED INTERMITTENTLY SINCE VAD IMPLANT. UPON ARRIVAL TO THE IMPLANTING CENTER, THE PATIENT HAD DECREASED BUT PAINFUL URINATION WITH ASSOCIATED ABDOMINAL PAIN, URINARY FREQUENCY AND URINARY RETENTION. THE PATIENT ALSO HAD ONGOING SHORTNESS OF BREATH, PITTING EDEMA, FLUID RETENTION AND HYPONATREMIA DUE TO DIURESIS. DIALYSIS WAS NOT REQUIRED AND THE PATIENT WAS MAINTAINED ON INTRAVENOUS (IV) DIURETICS. UROLOGY WAS CONSULTED FOR URINARY SYMPTOMS AND PATIENT¿S HOME DOSE OF FLOMAX WAS INCREASED AS WELL AS ORDERS FOR STRAIGHT URINARY CATHETERIZATION AS NEEDED. THE PATIENT WAS FOUND TO HAVE IRON DEFICIENCY ANEMIA WITH LABORATORY DATA AND RECEIVED SEVERAL DOSES OF IV IRON. LABS ALSO SHOWED SEVERAL DAYS OF LEUKOCYTOSIS AND BLOOD AND URINE CULTURES WERE DONE TO RULE OUT INFECTIOUS PROCESS AND ULTIMATELY WAS THOUGHT TO BE ELEVATED DUE TO A GOUT FLARE. DIURETICS WERE TRANSITIONED FROM IV TO ORAL AND THE PATIENT WAS DISCHARGED TO A REHAB FACILITY. THE VAD REMAINS 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
    2205155 HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP VENTRICULAR (ASSISST) BYPASS DSQ HEARTWARE, INC. 1103 00888707002639

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Male Required Intervention| H DDMB1D4 ICD, 5076-52 LEAD, 6395M62 LEAD.