BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP

    MDR report key: 13500165 · Received February 9, 2022

    Report

    Report Number
    3007042319-2022-02441
    Event Type
    Injury
    Date Received
    February 9, 2022
    Date of Event
    February 3, 2020
    Report Date
    April 18, 2022
    Manufacturer
    HEARTWARE, INC.
    Product Code
    DSQ
    PMA / PMN Number
    P100047
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MEDTRONIC WAS MADE AWARE OF THIS EVENT THROUGH A SEARCH OF LITERATURE PUBLICATIONS. IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DE VICE INFORMATION FROM THE LITERATURE PUBLICATION OR TO MATCH THE EVENT WITH PREVIOUSLY REPORTED EVENTS. THIS INFORMATION IS BASED ENTIRELY ON JOURNAL LITERATURE. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS LIMITED DUE TO CONFIDENTIALITY CONCERNS. WITHOUT A LOT NUMBER OR DEVICE SERIAL NUMBER, THE MANUFACTURING DATE CANNOT BE DETERMINED. SINCE NO DEVICE ID WAS PRO VIDED, IT IS UNKNOWN IF THIS EVENT HAS BEEN PREVIOUSLY REPORTED. REQUEST FOR ADDITIONAL INFORMATION WILL BE MADE AND, UPON RECEIPT, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY. REFERENCED ARTICLE: USEFULNESS OF HVAD WAVEFORMS AS DIAGNOSTIC ASSISTANCE FOR CARDIAC TAMPONADE. AMERICAN SOCIETY FOR ARTIFICIAL INTERNAL ORGANS, JOURNAL, APRIL 2021; 67(4):E90-E92. DOI: 10.1097/MAT.0000000000001303. PMID: 33181545.

    Additional Manufacturer Narrative · 0

    ### A SUPPLEMENTAL REPORT IS BEING SUBMITTED FOR INVESTIGATION COMPLETION. PRODUCT EVENT SUMMARY: THE PUMP WAS NOT RETURNED FOR EVALUATION. THE REPORTED LOW FLOW EVENT COULD NOT BE CONFIRMED SINCE LOG FILES WERE NOT PROVIDED FOR ANALYSIS. INFORMATION PROVIDED BY THE SITE INDICATED THAT THE PATIENT'S COURSE WAS COMPLICATED BY CONTINUOUS INTRA-OPERATIVE PERICARDIAL AND MEDIASTINAL BLEEDING, REQUIRING BLOOD PRODUCT TRANSFUSIONS AND ADDITIONAL ANTI-COAGULATION REVERSAL MEDICATION. POST-OPERATIVELY, THE PATIENT REQUIRED MULTIPLE TRANSFUSIONS AND A TRANSTHORACIC ECHOCARDIOGRAPHY SHOWED A LARGE PERICARDIAL HEMATOMA. SEVERAL DAYS LATER, AFTER DRAINAGE TUBE REMOVAL, THE PATIENT COMPLAINED OF LEFT ABDOMINAL PAIN AND A CHEST COMPUTERIZED TOMOGRAPHY REVEALED THE PERICARDIAL HEMATOMA STILL PRESENT. TWO DAYS LATER, THE DECISION WAS MADE TO PERFORM A THORACOTOMY TO REMOVE THE HEMATOMA AFTER THE PATIENT EXPERIENCED TACHYCARDIA AND PULSUS PARADOXUS, EVIDENCED BY AN ELECTROCARDIOGRAM. AFTER SURGERY, THE PULSUS PARADOXUS RESOLVED AND THE PATIENT BECAME HEMODYNAMICALLY STABLE WITH ABDOMINAL PAIN RESOLVING. BASED ON THE AVAILABLE INFORMATION, INCLUDING THE OCCURRENCE OF THE EVENT WITHIN 30 DAYS OF IMPLANT, 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 EVENT 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. PER THE INSTRUCTIONS FOR USE, BLEEDING AND CARDIAC ARRHYTHMIAS ARE KNOWN POTENTIAL COMPLICATIONS ASSOCIATED WITH THE IMPLANTATION OF A VAD. 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.

    Additional Manufacturer Narrative · 0

    A SUPPLEMENTAL REPORT IS BEING SUBMITTED FOR ADDITIONAL INFORMATION. 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 WHICH CONTAINED INFORMATION REGARDING VENTRICULAR ASSIST DEVICES (VADS). THE ARTICLE WAS A CASE REPORT ON DIAGNOSIS OF CARDIAC TAMPONADE USING VAD FLOW WAVEFORMS. ONE PATIENT'S COURSE WAS COMPLICATED BY CONTINUOUS INTRA-OPERATIVE PERICARDIAL AND MEDIASTINAL BLEEDING, REQUIRING BLOOD PRODUCT TRANSFUSIONS AND ADDITIONAL ANTI-COAGULATION REVERSAL MEDICATION. POST-OPERATIVELY, THE PATIENT REQUIRED MULTIPLE TRANSFUSIONS AND A TRANSTHORACIC ECHOCARDIOGRAPHY (TTE) SHOWED A LARGE PERICARDIAL HEMATOMA. BY DAY 10, AFTER DRAINAGE TUBE REMOVAL, THE PATIENT COMPLAINED OF LEFT ABDOMINAL PAIN AND A CHEST COMPUTERIZED TOMOGRAPHY (CT) REVEALED THE PERICARDIAL HEMATOMA STILL PRESENT, ACCOMPANIED BY REDUCED VAD FLOWS AND PULSATILITY. TWO DAYS LATER THE DECISION WAS MADE TO PERFORM A THORACOTOMY TO REMOVE THE HEMATOMA AFTER THE PATIENT EXPERIENCED TACHYCARDIA AND PULSUS PARADOXUS, EVIDENCED BY AN ELECTROCARDIOGRAM (EKG). AFTER SURGERY, THE PULSUS PARADOXUS RESOLVED AND THE PATIENT BECAME HEMODYNAMICALLY STABLE WITH ABDOMINAL PAIN RESOLVING. THE VAD PARAMETERS RETURNED TO NORMAL. 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
    233597 HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP VENTRICULAR (ASSISST) BYPASS DSQ HEARTWARE, INC. 1104

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Male Life Threatening| R