BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC NAVIGATION

    MDR report key: 14291070 · Received May 5, 2022

    Report

    Report Number
    1723170-2022-00693
    Event Type
    Injury
    Date Received
    May 5, 2022
    Date of Event
    December 7, 2019
    Report Date
    May 4, 2022
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PATIENT AGE IS THE MEAN VALUE OF PATIENTS IN THE STUDY. PATIENT GENDER IS THE MAJORITY VALUE OF PATIENTS IN THE STUDY. PATIENT WEIGHT NOT AVAILABLE FROM THE SITE. EVENT DATE IS THE ONLINE PUBLISHING DATE OF THE PUBLICATION. DEVICE LOT NUMBER, OR SERIAL NUMBER, UNAVAILABLE. NO PARTS HAVE BEEN RECEIVED BY THE MANUFACTURER FOR EVALUATION. DEVICE MANUFACTURE DATE IS DEPENDENT ON THE DEVICE LOT/SERIAL NUMBER, THEREFORE IS UNAVAILABLE. 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

    CITATION: ALBERT MCANSAH ISAACS, MD, DANAE KRAHN, MD, ANDREW M. WALKER, PHD, HEATHER HURDLE, MD, MSC, MARK G. HAMILTON, MDCM. TRANSESOPHAGEAL ECHOCARDIOGRAPHY-GUIDED VENTRICULOATRIAL SHUNT INSERTION. OPERATIVE NEUROSURGERY 19:25¿31, 2020 DOI: 10.1093/ONS/OPZ353 ABSTRACT: BACKGROUND: DETERMINING AN OPTIMAL LOCATION WITHIN THE RIGHT ATRIUM (RA) FOR PLACEMENT OF THE DISTAL VENTRICULOATRIAL (VA) SHUNT CATHETER OFFER SEVERAL OPERATIVE CHALLENGES THAT PLACE PATIENTS AT RISK FOR PERIOPERATIVE COMPLICATIONS AND DOWNSTREAM VA SHUNT FAILURE. UTILIZING TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE) GUIDANCE TO PLACE DISTAL VA SHUNT CATHETERS MAY HELP TO CIRCUMVENT THESE RISKS. OBJECTIVE: TO REVIEW OUR CURRENT PRACTICE OF VA SHUNT INSERTION USING TEE GUIDANCE METHODS: A RETROSPECTIVE REVIEW OF ALL CONSECUTIVE PATIENTS WHO UNDERWENT VA SHUNT PROCEDURES BETWEEN DECEMBER 19, 2016 AND JANUARY 22, 2019, DURING WHICH TIME INTRAOPERATIVE TEE WAS USED FOR SHUNT PLACEMENT WAS PERFORMED. DATA ON THE TIME REQUIRED FOR SHUNT PLACEMENT AND TOTAL PROCEDURE TIME, BASELINE ECHOCARDIOGRAPHY FINDINGS, AND SHORT AND LONG-TERM COMPLICATIONS OF SHUNT PLACEMENT WERE ASSESSED. RESULTS: A TOTAL OF 33 PATIENTS UNDERWENT VA SHUNT PROCEDURES, WITH A MEDIAN FOLLOW-UP TIME OF 250 (88-412) D. THE ONLY IMMEDIATE COMPLICATION RELATED TO SHUNT PLACEMENT OR TEE USE WAS TRANSIENT ECTOPY IN 1 PATIENT. THE MEAN TIME FOR ATRIAL CATHETER INSERTION WAS 12.6 ± 4.8 MIN. RIGHT-HEART CATHETERS WERE INSERTED BETWEEN THE RA-SUPERIOR VENA CAVA JUNCTION AND 22 MM WITHIN THE RA IN ALL BUT 3 PROCEDURES. A TOTAL OF 7/33 PATIENTS (21%) UNDERWENT SHUNT REVISION. INDICATIONS FOR REVISIONS INCLUDED DISTAL CLOTS, PROXIMAL OBSTRUCTION, POSITIVE BLOOD CULTURE, AND SHUNT VALVE REVISION. NO OTHER COMPLICATIONS OF VA SHUNT INSERTION WERE REPORTED. CONCLUSION: VA SHUNT INSERTION USING TEE ALLOWS FOR PRECISE DISTAL CATHETER PLACEMENT. EARLY PATIENT EXPERIENCE CONFIRMS THIS TECHNIQUE HAS A LOW COMPLICATION RATE. REPORTED EVENT(S): ONE PATIENT EXPERIENCED A SELF-LIMITING ATRIAL FIBRILLATION THAT WAS NOTED TO BE BRIEF AND DUE TO THE SHUNT PLACEMENT AND TEE USAGE. FIVE CATHETERS REQUIRED REVISION DUE TO A DISTAL CLOT ONE CATHETER REQUIRED REVISION DUE TO A PROXIMAL OBSTRUCTION ONE CATHETER REQUIRED REVISION DUE TO A POSITIVE BLOOD CULTURE ONE CATHETER REQUIRED REVISION DUE TO A BROKEN PROXIMAL VALVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1463807 MEDTRONIC NAVIGATION NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC UNK_NAV_SYS

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Male Required Intervention