BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP

    MDR report key: 13111634 · Received December 29, 2021

    Report

    Report Number
    3007042319-2021-08469
    Event Type
    Injury
    Date Received
    December 29, 2021
    Date of Event
    January 5, 2021
    Report Date
    March 7, 2022
    Manufacturer
    HEARTWARE, INC.
    Product Code
    DSQ
    UDI-DI
    00888707003261
    PMA / PMN Number
    P100047
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION OF THIS EVENT IS PENDING AND A SUPPLEMENTAL REPORT WILL BE SENT UPON ITS COMPLETION. THIS INFORMATION WAS RECEIVED FROM THE MECHANICAL CIRCULATORY SUPPORT PRODUCT SURVEILLANCE REGISTRY STUDY. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 0

    ### A SUPPLEMENTAL REPORT IS BEING SUBMITTED FOR INVESTIGATION COMPLETION. PRODUCT EVENT SUMMARY: THE VENTRICULAR ASSIST DEVICE (VAD) WAS NOT RETURNED FOR EVALUATION. THE REPORTED LOW FLOW AND SUCTION EVENTS WERE NOT CONFIRMED VIA REVIEW OF THE CONTROLLER LOG FILES SINCE LOG FILES COVERING THE REPORTED EVENT DATE WERE NOT AVAILABLE FOR ANALYSIS. INFORMATION PROVIDED BY THE SITE INDICATED THAT, IN ADDITION TO THE REPORTED LOW FLOWS AND SUCTION, THE PATIENT'S CREATININE LEVEL INCREASED, CONSISTENT WITH AN ACUTE KIDNEY INJURY (AKI); THE PATIENT WAS INITIALLY TREATED WITH INTRAVENOUS LASIX DIURETICS AND, WHEN THE AKI DIDN'T IMPROVE, DIURESIS WAS HELD FOR ONE DAY. ADDITIONALLY, THE PATIENT UNDERWENT A RIGHT HEART CATHETERIZATION WHICH REVEALED ELEVATED RIGHT SIDED PRESSURES AND COMPENSATED PULMONARY WEDGE PRESSURE. BASED ON THE AVAILABLE INFORMATION, THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. BASED ON RISK DOCUMENTATION, MULTIPLE FACTORS MAY HAVE CONTRIBUTED TO THE REPORTED LOW FLOW AND SUCTION EVENTS INCLUDING BUT NOT LIMITED TO POOR VAD FILLING, THROMBUS AT THE INFLOW CANNULA/OUTFLOW GRAFT, CONSTRICTION AT THE OUTFLOW GRAFT, AND/OR INAPPROPRIATE PUMP ROTATIONAL SPEED. PER THE INSTRUCTIONS FOR USE, RENAL DYSFUNCTION IS A K KNOWN POTENTIAL COMPLICATION ASSOCIATED WITH THE IMPLANTATION OF A VAD. THERE WAS NO EVIDENCE THAT THE PATIENT HAD A HISTORY OF RENAL DYSFUNCTION EVENTS. 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 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

    IT WAS REPORTED THAT THE VENTRICULAR ASSIST DEVICE (VAD) HAD THREE (3) LOW FLOW ALARMS AND THE WAVE FORM WAS SUGGESTIVE OF A SUCTION EVENT. THE PATIENT WAS HOSPITALIZED AND WHILE INPATIENT HAD ONE MORE LOW FLOW ALARM AND THE ETIOLOGY OF THE ALARMS WERE UNCLEAR. THE PATIENT'S CREATININE WENT FROM A BASELINE OF 1.5-1.8 TO 3.08 CONSISTENT WITH AN ACUTE KIDNEY INJURY (AKI). THE PATIENT WAS INITIALLY TREATED WITH INTRAVENOUS LASIX DIURETICS AND WHEN THE AKI DIDN'T IMPROVE, DIURESIS WAS HELD FOR ONE DAY. THE PATIENT THEN UNDERWENT A RIGHT HEART CATHETERIZATION WHICH REVEALED ELEVATED RIGHT SIDED PRESSURES AND COMPENSATED PULMONARY WEDGE PRESSURE. THIS WAS NOT CONSISTENT WITH EITHER HYPO OR HYPERVOLEMIA. A TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) SHOWED NO SIGNIFICANT CHANGES EITHER. A RECHECK OF THE CREATININE LEVELS AFTER HOLDING THE DIURETICS FOR ONE DAY SHOWED IT IMPROVED FROM 3 TO 2.69. 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
    2009852 HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP VENTRICULAR (ASSISST) BYPASS DSQ HEARTWARE, INC. 1103 00888707003261

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Female Required Intervention| H DVBC3D4 ICD, 6935M62 LEAD