BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOVEROUND

    MDR report key: 8796442 · Received July 16, 2019

    Report

    Report Number
    1056601-2019-00012
    Event Type
    Injury
    Date Received
    July 16, 2019
    Date of Event
    January 14, 2019
    Report Date
    August 15, 2019
    Manufacturer
    HOVEROUND CORPORATION
    Product Code
    ITI
    PMA / PMN Number
    K042545
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ACCORDING TO INFORMATION FROM THE CRYOLIFE IMPLANT DATABASE, THE CRYOPATCH SG PULMONARY TRUNK PATCH WAS IMPLANTED IN A 5-DAY OLD FEMALE NEONATE DURING A NORWOOD PROCEDURE ON (B)(6) 2018. THE PATIENT UNDERWENT A PLANNED/STAGED GLENN PROCEDURE ON (B)(6) 2019, AT WHICH TIME IT WAS ALLEGED THAT THE PATCH USED DURING THE NORWOOD PROCEDURE 4 MONTHS PRIOR ¿LOOKED CALCIFIED¿. THERE IS NO ADDITIONAL INFORMATION AVAILABLE REGARDING PATIENT DEMOGRAPHICS, PERTINENT MEDICAL HISTORY, PRE-OPERATIVE DIAGNOSES, HOW THE SG PATCH WAS USED IN THE NORWOOD PROCEDURE, THE DEGREE OF CALCIFICATION PRESENT, WHETHER THE CALCIFICATION WAS NOTED PRIOR TO THE PATIENT UNDERGOING THE PLANNED/STAGED GLENN PROCEDURE, OR IF THE ALLEGED CALCIFICATION WAS CAUSING ANY ISSUES RELATED TO CARDIAC FUNCTION OR PERFORMANCE. IN ADDITION, NONE OF THE ALLEGED CALCIFIED PATCH MATERIAL WAS EXPLANTED OR SUBMITTED FOR HISTOLOGY/PATHOLOGY AT THE IMPLANTING HOSPITAL OR PROVIDED TO CRYOLIFE FOR HISTOLOGICAL ANALYSIS. THE NORWOOD PROCEDURE IS THE FIRST STAGE OF A 3-PART SURGICAL PALLIATION PROCEDURE TO CORRECT HYPOPLASTIC LEFT HEART SYNDROME (HLHS). HYPOPLASTIC LEFT HEART SYNDROME (HLHS) CONSTITUTES A SPECTRUM OF CARDIAC ANOMALIES THAT RESULT IN UNDERDEVELOPMENT OF LEFT-SIDED HEART STRUCTURES. IT IS CHARACTERIZED BY UNDERDEVELOPMENT OF THE AORTA, AORTIC VALVE, LEFT VENTRICLE, MITRAL VALVE, AND LEFT ATRIUM, RESULTING IN SEVERE OR TOTAL OBSTRUCTION OF BLOOD FLOW FROM THE LEFT VENTRICLE (SIVANANDAM 2011). COARCTATION OF THE AORTA (NARROWING OF THE AORTA) IS THE MOST FREQUENTLY ASSOCIATED ANOMALY WITH HLHS AND WITHOUT SOME FORM OF INTERVENTION, HLHS IS UNIVERSALLY FATAL WITHIN THE FIRST WEEKS OF LIFE AND IS THE MOST COMMON CAUSE OF CARDIAC-RELATED DEATH IN CHILDREN LESS THAN ONE MONTH OF AGE (ATIK 2006). THE GOALS OF NORWOOD PROCEDURE ARE TO RELIEVE SYSTEMIC OUTFLOW TRACT OBSTRUCTION, PROVIDE NONRESTRICTIVE CORONARY BLOOD FLOW AND ADEQUATE PULMONARY BLOOD FLOW, AND CREATE A NONRESTRICTIVE ATRIAL SEPTAL DEFECT (FEINSTEIN 2012). THE NORWOOD PALLIATION OF HLHS INCLUDES CONSTRUCTING A NEO-AORTA UTILIZING THE PULMONARY ROOT, ASCENDING AORTA, AND CRYOPRESERVED HOMOGRAFT TISSUE (THE PATCH MATERIAL). THE DUCTAL TISSUE IS RESECTED AND THE AUGMENTATION OF THE AORTIC ARCH AND SITE OF COARCTATION IS CARRIED OUT. PULMONARY BLOOD FLOW IS PROVIDED BY PLACEMENT OF A SHUNT. THE NORWOOD PROCEDURE IS PERFORMED SHORTLY AFTER BIRTH WITHIN THE FIRST WEEK OF LIFE. THE SECOND PROCEDURE, KNOWN AS THE BI-DIRECTIONAL GLENN OR HEMI-FONTAN, IS PERFORMED BETWEEN 3-6 MONTHS OF AGE, AND THE FINAL STAGE, KNOWN AS THE FONTAN, BETWEEN 18 MONTHS-5 YEARS OF AGE. CRYOPATCH SG IS INDICATED FOR REPAIR OR RECONSTRUCTION OF THE RIGHT VENTRICULAR OUTFLOW TRACT; HOWEVER, IT IS UNKNOWN HOW THE CRYOPATCH SG WAS USED DURING THE NORWOOD PROCEDURE. CALCIFICATION IS INCLUDED IN THE IFU (INSTRUCTIONS FOR USE) AS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH THE USE OF CRYOPATCH SG. IN ADDITION, THE PATCH WAS LEFT IMPLANTED WHICH INDICATES THAT THE CALCIFICATION DID NOT SIGNIFICANTLY IMPACT HEMODYNAMICS. ALL RISKS IDENTIFIED HAVE BEEN MITIGATED AS FAR AS POSSIBLE AND RESIDUAL RISK IS ACCEPTABLE. THIS REPORT IS BEING SUBMITTED AS REQUIRED BY FEDERAL REGULATIONS AND DOES NOT CONSTITUTE AN ADMISSION THAT THE DEVICE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. FURTHERMORE, THIS REPORT REFLECTS THE EVENT AS ALLEGED BY THE COMPLAINANT AND DOES NOT IMPLY THAT THE INFORMATION REPORTED TO CRYOLIFE IS ACCURATE OR HAS BEEN CONFIRMED BY CRYOLIFE.

    Additional Manufacturer Narrative · 1

    NO MALFUNCTION IS SUSPECTED, HOWEVER EVALUATION IS PENDING. THE END USER WAS LEANING OVER THE ARM OF THE POWER WHEELCHAIR TO PICK UP AN OBJECT, HIT THE JOYSTICK WITH AN ARM OR SLEEVE, AND DROVE INTO AN OTTOMAN. HOVEROUND'S OWNER'S MANUAL WARNS "TO REDUCE THE CHANCE OF SERIOUS INJURY OR DEATH FROM TIP-OVER, COLLISION WITH OBSTACLES, LOSS OF CONTROL, OR FALLING FROM THE POWER WHEELCHAIR, KEEP YOURSELF PROPERLY POSITIONED IN THE SEAT: DO NOT REACH OVER THE BACK OF THE CHAIR OR LEAN EXCESSIVELY FORWARD OR SIDEWAYS." AND "TO AVOID SERIOUS INJURY OR DEATH FROM SUDDEN UNEXPECTED MOVEMENT OF THE CHAIR OR CONTACT WITH MOVING PARTS AND OTHER OBJECTS: WHEN SEATED IN A STATIONARY CHAIR, PRESS THE POWER BUTTON TO OFF."

    Description of Event or Problem · 1

    WHEN THE END USER LEANED OVER TO PICK AN OBJECT OFF THE FLOOR, THE END USER'S ARM OR SWEATER HIT THE JOYSTICK AND THE END USER RAN INTO AN OTTOMAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    588464 HOVEROUND MOTORIZED WHEELCHAIR ITI HOVEROUND CORPORATION MPV5

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization