BEUDAMED
    FDA Adverse Event Death Summary report: N

    ONYX

    MDR report key: 11733937 · Received April 27, 2021

    Report

    Report Number
    2029214-2021-00494
    Event Type
    Death
    Date Received
    April 27, 2021
    Date of Event
    November 2, 2017
    Report Date
    April 27, 2021
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    MFE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    RAVI N. SRINIVASA, RAJIV N. SRINIVASA, SARA ZHAO, JOSEPH J. GEMMETE, JACOB BUNDY, JEFFREY F.B. CHICK. BALLOON OCCLUSION TECHNIQUE WITH ETHYLENE VINYL ALCOHOL FOR THE TREATMENT OF A PEDIATRIC PULMONARY ARTERY MYCOTIC ANEURYSMRADIOLOGY CASE REPORTS 13(2018). DOI: 10 .1016/J.RADCR.2017.10.013 A B S T R A C T MYCOTIC ANEURYSMS, WHICH MAY OCCUR ANYWHERE IN THE BODY, MAY BE PRONE TO SPONTANEOUS RUPTURE. ANTIBIOTIC THERAPY COMBINED WITH SURGICAL DEBRIDEMENT WITHOUT OR WITH REVASCULARIZATION HAS BEEN DESCRIBED AS POTENTIAL TREATMENT OPTIONS. THIS REPORT DESCRIBES A COMBINED BALLOON OCCLUSION TECHNIQUE WITH THE INJECTION OF ETHYLENE-VINYL ALCOHOL COPOLYMER FOR THE TREATMENT OF AMYCOTIC ANEURYSM OF THE PULMONARY ARTERY SECONDARY TO INFECTIVE ENDOCARDITIS. SIMILAR TECHNIQUES HAVE BEEN DESCRIBED IN THE CEREBRAL CIRCULATION AND MAY OBVIATE CONCERNS FOR COIL EROSION, NON-TARGET EMBOLIZATION, OR SUPERINFECTION. REPORTED EVENT. A (B)(6) YEAR OLD GIRL WITH HISTORY OF DIGEORGE SYNDROME, PRIOR NEONATAL TRUNCUS ARTERIOSUS REPAIR, AND SEVERE LEFT PULMONARY ARTERY HYPOPLASIA PRESENTED WITH METHICILLIN-SENSITIVE STAPHYLOCOCCAL BACTEREMIA SECONDARY TO INFECTIVE ENDOCARDITIS COMPLICATED BY SEPTIC PULMONARY EMBOLI, BILATERAL PYELONEPHRITIS, AND SEPTIC SHOCK. BECAUSE OF WORSENING RESPIRATORY FAILURE AND PULMONARY HEMORRHAGE, THE PATIENT WAS PLACED ON VENOVENOUS EXTRACORPOREAL MEMBRANE OXYGENATION (V-V ECMO). SIX DAYS AFTER PLACEMENT ON V-V ECMO, ACUTE HEMORRHAGE WAS NOTED AROUND AND IN THE RIGHT CHEST TUBE AND ALSO IN THE ENDOTRACHEAL TUBE. COMPUTED TOMOGRAPHY ANGIOGRAPHY SHOWED A PATENT CONDUIT BETWEEN THE RIGHT VENTRICLE AND THE PULMONARY ARTERY, AN ACUTE RIGHT HEMOTHORAX, AND A 19-MM BILOBED PRESUMED MYCOTIC ANEURYSM INVOLVING THE MEDIAL BASAL SEGMENT OF THE RIGHT LOWER LOBE PULMONARY ARTERY. IN ADDITION, EXTRAVASATION WAS NOTED FROM AN INTERCOSTAL ARTERY AT THE SITE OF THE RIGHT CHEST TUBE. THE PATIENT WAS PLACED UNDER GENERAL ANESTHESIA WITH ADDITIONAL SUPPORT FROM A PERFUSIONIST TEAM TO MANAGE HER ECMO CIRCUIT. LEFT COMMON FEMORAL VEIN ACCESS WAS OBTAINED ANTEGRADE USING A MICROPUNCTURE SET, AND A 9-FRENCH, 70 CM FLEXOR SHEATH (COOK MEDICAL; BLOOMINGTON, IN) WAS PLACED INTO THE INFERIOR VENA CAVA. A 7-FRENCH APC CATHETER (COOK MEDICAL) WAS USED TO SELECT THE MAIN PULMONARY ARTERY. DIGITAL SUBTRACTION ARTERIOGRAPHY REVEALED A PATENT PULMONARY ARTERY CONDUIT AND CONFIRMED THE PRESENCE OF A 19-MM BILOBED MYCOTIC ANEURYSM ARISING FROM THE MEDIAL BASAL SEGMENT OF THE RIGHT LOWER LOBE PULMONARY ARTERY.THE GUIDING SHEATH WAS ADVANCED FURTHER INTO THE RIGHT PULMONARY ARTERY, AND A 5-FRENCH, 100 CM VERTEBRAL TIP CATHETER (ANGIODYNAMICS; LATHAM, NY) AND ANGLED TIP GLIDEWIRE (TERUMO; TOKYO, JAPAN) WERE USED TO CANNULATE THE BRANCH VESSEL FEEDING THE MYCOTIC ANEURYSM. GIVEN THE PATIENTS HISTORY OF ENDOCARDITIS AND ACUTE HEMORRHAGE IN THE ENDOTRACHEAL TUBE, THE THOUGHT WAS THIS MOST LIKELY REPRESENTED A FRIABLE MYCOTIC ANEURYSM, WHICH WOULD BE PRONE TO RUPTURE WITH ANY SIGNIFICANT MANIPULATION. BASED ON THIS, A DECISION WAS MADE TO OCCLUDE THEMYCOTIC ANEURYSM USING THE BALLOON OCCLUSION TECHNIQUE WITH THE INJECTION OF EVOH (ONYX). A 150-CM, SCEPTER C OCCLUSION BALLOON CATHETER (MICROVENTION; TUSTIN, CA) WAS ADVANCED COAXIALLY AND PLACED AT THE NECK OF THE MYCOTIC ANEURYSM OVER A SYNCHRO 0.014-INCH WIRE (STRYKER NEUROVASCULAR; KALAMAZOO, MI). THE OCCLUSION BALLOON WAS GENTLY INFLATED TO 5 MM IN THE PARENT VESSEL USING A CADENCE PRECISION INJECTOR SYRINGE (EV3, COVIDIEN; PLYMOUTH, MN).THE DEAD SPACE OF THE CATHETER WAS THEN PRIMED WITH DIMETHYL SULFOXIDE, AND EVOH (ONYX 34; EV3, COVIDIEN) WAS THEN SLOWLY INJECTED INTO THE MYCOTIC ANEURYSM, FILLING IT COMPLETELY.THE BALLOON WAS DEFLATED AND REPEAT PULMONARY ARTERIOGRAPHY SHOWED OCCLUSION OF THE MYCOTIC ANEURYSM AND PRESERVED FLOW TO NORMAL LUNG PARENCHYMA. RIGHT FEMORAL ARTERIAL ACCESS WAS THEN OBTAINED, AND A THORACIC AORTOGRAM REVEALED EXTRAVASATION FROM A RIGHT INTERCOSTAL ARTERY. THE ARTERY WAS SELECTED AND SUCCESSFULLY TREATED WITH COILS AND GELFOAM. TOTAL PROCEDURE TIME WAS 132 MINUTES. THE PATIENT RETURNED TO THE PEDIATRIC INTENSIVE CARE UNIT IN STABLE CONDITION. HEMORRHAGE INTO THE RIGHT CHEST TUBE AND ENDOTRACHEAL TUBE RESOLVED COMPLETELY 24 HOURS AFTER THE PROCEDURES. UNFORTUNATELY, CARE WAS WITHDRAWN BECAUSE OF NEUROLOGIC DETERIORATION 3 DAYS AFTER THE PROCEDURE. THE FAMILY DECLINED AN AUTOPSY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    630282 ONYX AGENT, INJECTABLE, EMBOLIC MFE MICRO THERAPEUTICS, INC. DBA EV3 UNK-NV-ONYX UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Death