BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP

    MDR report key: 10359556 · Received August 3, 2020

    Report

    Report Number
    3007042319-2020-05191
    Event Type
    Injury
    Date Received
    August 3, 2020
    Date of Event
    July 24, 2020
    Report Date
    October 21, 2020
    Manufacturer
    HEARTWARE, INC.
    Product Code
    DSQ
    PMA / PMN Number
    P100047
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    A SUPPLEMENTAL REPORT IS BEING SUBMITTED FOR DEVICE EVALUATION. PRODUCT EVENT SUMMARY: THE VENTRICULAR ASSIST DEVICE (VAD) AND TWO (2) SEGMENTS OF THE ASSOCIATED OUTFLOW GRAFT WERE RETURNED FOR EVALUATION. VARIOUS ANALYSES WERE CONDUCTED AND REVIEWED IN ORDER TO EVALUATE THE PERFORMANCE OF THE DEVICES IN RELATION TO THE REPORTED EVENT. FAILURE ANALYSIS OF THE RETURNED SEGMENTS OF OUTFLOW GRAFT REVEALED THAT THE DEVICE PASSED VISUAL EXAMINATION. FAILURE ANALYSIS OF THE RETURNED PUMP REVEALED THAT THE DEVICE PASSED FUNCTIONAL TESTING AND DIMENSIONAL VERIFICATION BUT VISUAL EXAMINATION REVEALED SCORING MARKS ON THE LOWER HOUSING CERAMIC SURFACE AND ON THE INFERIOR SURFACE OF THE IMPELLER. CONSIDERING THAT THE RETURNED DEVICE PASSED FUNCTIONAL EXAMINATION, THESE FRICTION MARKS ARE INDICATIVE THAT AN EXTERNAL FACTOR SUCH AS THROMBUS MAY HAVE FORCED THE IMPELLER AGAINST THE REAR HOUSING WITH SUFFICIENT STRENGTH TO OVERCOME THE REAR PRELOAD OF THE MAGNETIC SPRING/SUSPENSION SYSTEM. AS SUCH, THE PRESENCE OF FRICTION MARKS IS LIKELY A SYMPTOM OF THE CLINICAL CHALLENGE THE PUMP HAS EXPERIENCED AND IS GENERALLY NOT EVIDENCE OF A PUMP INDUCED PROBLEM. INTERNAL PATHOLOGICAL REPORT REVEALED EVIDENCE OF THROMBUS WITHIN THE PUMP. LOG FILE ANALYSIS REVEALED SEVERAL INTERMITTENT SUCTION EVENTS WITHIN THE ANALYZED PERIOD. ADDITIONALLY, A STEADY DECLINE IN POWER CONSUMPTION AND ESTIMATED FLOWS WAS LOGGED STARTING ON (B)(6) 2020, FOLLOWED BY A SUDDEN DECREASE IN POWER AND FLOWS ON (B)(6) 2020 TO PARAMETERS BELOW THE NORMAL OPERATING RANGE. SEVERAL SUBSEQUENT INCREASES AND DECREASES IN PARAMETERS WERE SUBSEQUENTLY LOGGED, INCLUDING A SHARP INCREASE IN POWER AND FLOW ON (B)(6) 2020. 294 LOW FLOW ALARMS WERE LOGGED SINCE (B)(6) 2020 AND 33 HIGH WATT ALARMS WERE LOGGED SINCE (B)(6) 2020. ADDITIONALLY, SEVERAL VAD DISCONNECT ALARMS WERE LOGGED ON (B)(6) 2020, INDICATING A PHYSICAL DISCONNECTION OF THE DRIVELINE FROM THE CONTROLLER, LIKELY DURING A CONTROLLER EXCHANGE AND/OR TROUBLESHOOTING. AS A RESULT, THE REPORTED EVENT WAS CONFIRMED. OF NOTE, IT WAS REPORTED THAT THE PATIENT WAS TREATED WITH ANTICOAGULANTS, THROMBOLYTIC THERAPY, AND ANTIPLATELET THERAPY. BASED ON THE AVAILABLE INFORMATION, THERE IS NO EVIDENCE TO INDICATE THAT A DEVICE MALFUNCTION OR PERFORMANCE ISSUE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. BASED ON THE RISK DOCUMENTATION, POSSIBLE CAUSES OF THE REPORTED LOW FLOW AND SUCTION EVENTS MAY BE ATTRIBUTED TO MULTIPLE FACTORS INCLUDING BUT NOT LIMITED TO THROMBUS AT THE INFLOW CANNULA/OUTFLOW GRAFT, CONSTRICTION AT THE OUTFLOW GRAFT, POOR VAD FILLING, AND/OR INAPPROPRIATE PUMP ROTATIONAL SPEED. THE MOST LIKELY ROOT CAUSE OF THE HIGH POWER EVENT CAN BE ATTRIBUTED TO EXTERNAL FACTORS SUCH AS THROMBUS FORMATION/INGESTION. PER THE INSTRUCTIONS FOR USE, DEVICE THROMBUS IS A KNOWN POTENTIAL COMPLICATION ASSOCIATED WITH THE IMPLANTATION OF A VAD. BASED ON REVIEW OF PAST ADVERSE EVENTS FOR THIS PATIENT, IT WAS NOTED THAT THE PATIENT HAD PREVIOUSLY EXPERIENCED A THROMBUS EVENT. 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. ADDITIONAL PRODUCTS: D1: HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ OUTFLOW GRAFT, D10:YES (B)(6) 2020, H3: YES H6:METHOD CODE(S):10 H6: FDA RESULTS CODE(S): 213 H6: FDA CONCLUSION CODE(S): 67,22 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.

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR TREATMENT NOT DIAGNOSIS. THE VENTRICULAR ASSIST SYSTEM IS INDICATED FOR USE AS A BRIDGE TO CARDIAC TRANSPLANTATION AND DESTINATION THERAPY IN PATIENTS WHO ARE AT RISK OF DEATH FROM REFRACTORY END-STAGE LEFT VENTRICULAR HEART FAILURE. THE SYSTEM IS DESIGNED FOR IN-HOSPITAL AND OUT-OF-HOSPITAL SETTINGS. ADDITIONAL PRODUCTS: HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ OUTFLOW GRAFT MODEL #: 1125 / CATALOG #: 1125 / EXPIRATION DATE: 31-OCT-2020 / LOT#: 368896-8257. UDI #: (B)(4). DEVICE AVAILABLE FOR EVALUATION: NO, DEVICE EVAL. BY MFR: NO, DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN, MFG DATE: 01-OCT-2015, LABELED FOR SINGLE USE: NO. (B)(4). INVESTIGATION OF THIS EVENT IS PENDING AND A SUPPLEMENTAL REPORT WILL BE SENT UPON ITS COMPLETION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VENTRICULAR ASSIST DEVICE (VAD) PATIENT WAS HOSPITALIZED FOR SUSPECTED THROMBUS IN THE INFLOW CANNULA AND OUTFLOW GRAFT. THE VAD EXHIBITED MULTIPLE LOW FLOW ALARMS AND SUCTION EVENT. THE PATIENT HAD ELEVATED LACTATE DEHYDROGENASE (LDH) AND WAS TREATED WITH ANTICOAGULANTS THAT WERE INJECT SUBCUTANEOUSLY TWICE, THROMBOLYTIC AND ANTIPLATELET THERAPY. A TRANSTHORACIC ECHOCARDIOGRAM (TTE), COMPUTERIZED TOMOGRAPHY (CT) SCAN, AND ULTRASOUND OF THE HEART WERE PERFORMED. IT WAS FURTHER STATED THAT THE VAD EXHIBITED HIGH WATTS ALARM AND THAT THE PATIENT WAS IN THE OPERATING ROOM (OR) FOR A VAD EXCHANGE FOR THROMBUS AND VAD STOP. THE VAD AND THE OUTFLOW GRAFT WERE EXPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    823528 HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP VENTRICULAR (ASSIST) BYPASS DSQ HEARTWARE, INC. 1104

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization| L| R