BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP/DRIVELINE

    MDR report key: 11866321 · Received May 21, 2021

    Report

    Report Number
    3007042319-2021-03699
    Event Type
    Injury
    Date Received
    May 21, 2021
    Date of Event
    May 17, 2021
    Report Date
    July 22, 2021
    Manufacturer
    HEARTWARE, INC.
    Product Code
    DSQ
    UDI-DI
    00888707000017
    PMA / PMN Number
    P100047
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    A SUPPLEMENTAL REPORT IS BEING SUBMITTED FOR DEVICE EVALUATION. ADDITIONAL PRODUCT: D4: MODEL 1125/LOT NUMBER: 0001804248 H6: FDA METHOD CODE(S): B17 H6: FDA RESULTS CODE(S): C20 H6: FDA CONCLUSION CODE(S): D14,D12 PRODUCT EVENT SUMMARY: THE PUMP AND THE ASSOCIATED OUTFLOW GRAFT WERE NOT RETURNED FOR EVALUATION. THE REPORTED LOW FLOW EVENT WAS CONFIRMED THROUGH LOG FILE ANALYSIS WHICH REVEALED A SUSTAINED DECREASE IN POWER CONSUMPTION AND ESTIMATED FLOWS BEGINNING ON (B)(6) 2021, FOLLOWED BY A SUDDEN DECREASE IN POWER CONSUMPTION AND ESTIMATED FLOWS ON (B)(6) 2021. 108 LOW FLOW ALARMS WERE RECORDED ON (B)(6) 2021. INFORMATION PROVIDED BY THE SITE INDICATED THAT THE PATIENT WAS ADMITTED WITH NAUSEA AND FATIGUE. THE PATIENT'S INTERNATIONAL NORMALIZED RATIO (INR) WAS IN RANGE AND LACTATE DEHYDROGENASE (LDH) WAS 219 AND STABLE. A TRANSTHORACIC ECHOCARDIOGRAM (TTE) AND A COMPUTERIZED TOMOGRAPHY (CT) SCAN WERE PERFORMED SHOWING AN OCCLUSION IN THE OUTFLOW GRAFT (OFG). OF NOTE, IT WAS REPORTED THAT SURGERY WAS PERFORMED TO REMOVE AN ADDITIONAL SURROUNDING GRAFT PLACED BY THE SURGEON AT IMPLANT, AFTER WHICH FLOWS RETURNED TO NORMAL. BASED ON THE AVAILABLE INFORMATION, THERE IS NO EVIDENCE TO SUGGEST THAT A DEVICE MALFUNCTION CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. BASED ON THE AVAILABLE INFORMATION, THE MOST LIKELY ROOT CAUSE OF THE REPORTED LOW FLOW EVENT CAN BE ATTRIBUTED, BUT NOT LIMITED, TO CONSTRICTION AT THE OUTFLOW GRAFT DUE TO EXTERNAL COMPRESSION FROM THE ADDITIONAL SURROUNDING GRAFT PLACED BY THE SURGEON AT IMPLANT. 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, 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 · 1

    OTHER DEVICES INVOLVED IN THIS EVENT: HEARTWARE VENTRICULAR ASSIST SYSTEM  OUTFLOW GRAFT, MODEL 1125, LOT NUMBER: 0001804248 ,EXPIRATION DATE: UNK, UDI ASKU, (B)(4). MFG DATE: UNK, (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    THE VENTRICULAR ASSIST DEVICE (VAD) EXHIBITED LOW FLOWS THAT TRIGGERED MULTIPLE LOW FLOW ALARMS. THE PATIENT WAS ADMITTED WITH NAUSEA AND FATIGUE. THE PATIENT'S INTERNATIONAL NORMALIZED RATIO (INR) WAS IN RANGE AND LACTATE DEHYDROGENASE (LDH) WAS 219 AND STABLE . A TRANSTHORACIC ECHOCARDIOGRAM (TTE) AND A COMPUTERIZED TOMOGRAPHY (CT) SCAN WERE PERFORMED SHOWING AN OCCLUSION IN THE OUTFLOW GRAFT (OFG). THE PATIENT WAS TAKEN TO THE OPERATING ROOM (OR) TO REMOVE THE RIGID VASCULAR GRAPH AND FLOWS RETURNED TO NORMAL. THE VAD AND OUTFLOW GRAFT REMAIN IMPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    763338 HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP/DRIVELINE VENTRICULAR (ASSISST) BYPASS DSQ HEARTWARE, INC. 1103 00888707000017

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Hospitalization| L| R