BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONYX

    MDR report key: 17731602 · Received September 12, 2023

    Report

    Report Number
    2029214-2023-01666
    Event Type
    Injury
    Date Received
    September 12, 2023
    Date of Event
    November 9, 2020
    Report Date
    September 12, 2023
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    MFE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    G2: CITATION: AUTHORS: ALLUHAYBI A, ABDULQADER S, ALTUHAYNI K, ALTURKSTANI A, KABBANI A, AHMAD M. PREOPERATIVE TRANS-ARTERIAL EMBOLI ZATION OF A GIANT SCALP CONGENITAL HEMANGIOMA ASSOCIATED WITH CARDIAC FAILURE IN A PREMATURE NEWBORN. JOURNAL OF INTERNATIONAL MEDICAL RESEARCH 48(12) 1¿7 2020. 10.1177/0300060520977589. DATE OF PUBLICATION USED FOR DATE OF EVENT NO UNIQUE DEVICE IDENTIFIER (SERIAL/LOT) NUMBERS WERE PROVIDED; WITHOUT THIS INFORMATION IT COULD NOT BE DETERMINED WHETHER THESE OBSERVATIONS HAVE BEEN PREVIOUSLY REPORTED. WITHOUT RETURN OF THE PRODUCT NO DEFINITIVE CONCLUSION CAN BE MADE REGARDING THE CLINICAL OBSERVATIONS. 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

    ALLUHAYBI  A, ABDULQADER S, ALTUHAYNI K, ALTURKSTANI A, KABBANI A, AHMAD M. PREOPERATIVE TRANS-ARTERIAL EMBOLIZATION OF A GIANT SCALP CONGENITAL HEMANGIOMA ASSOCIATED WITH CARDIAC FAILURE IN A PREMATURE NEWBORN. JOURNAL OF INTERNATIONAL MEDICAL RESEARCH 2020; 48(12) 1¿7. DOI: 10.1177/0300060520977589. LITERATURE WAS REVIEWED REGARDING PREOPERATIVE TRANS-ARTERIAL EMBOLIZATION OF A GIANT SCALP CONGENITAL HEMANGIOMA ASSOCIATED WITH CA RDIAC FAILURE IN A PREMATURE NEWBORN USING ONYX. THE PATIENT¿S RIGHT LOWER LIMB BECAME PALE WITH WEAK PULSES POSTEMBOLIZATION. ULTRASOUND DOPPLER OF THE RIGHT LOWER LIMB SHOWED SPASMS IN THE RIGHT EXTERNAL ILIAC ARTERY, RIGHT COMMON FEMORAL ARTERY, AND PROXIMAL RIGHT SUPERFICIAL FEMORAL ARTERY WITHOUT EVIDENCE OF THROMBOSIS. VASCULAR SURGERY, NEUROINTERVENTION, AND HEMATOLOGY TEAMS WERE CONSULTED. FOLLOWING CONSERVATIVE MANAGEMENT, HEPARIN WAS INITIATED AT A THERAPEUTIC DOSE. A FEW DAYS LATER, HIS LEG VASCULARITY IMPROVED WITH NO PERMANENT INJURY. WITHIN 14 DAYS POSTEMBOLIZATION, THE CIRCUMFERENCE OF THE LESION HAD DECREASED FROM 23 CM TO 18 CM. THE PATIENT¿S CARDIAC FUNCTION IMPROVED AFTER EMBOLIZATION. HE UNDERWENT SURGICAL RESECTION 14 DAYS AFTER EMBOLIZATION AND DISCONTINUATION OF HEPARIN. TOTAL RESECTION OF THE LESION WITH MINIMAL BLOOD LOSS WAS ACHIEVED. POSTOPERATIVELY, THE PATIENT WAS EXTUBATED, AND HE MAINTAINED SATURATION IN ROOM AIR. HE WAS DISCHARGED 1 WEEK AFTER SURGERY. THE HISTOPATHOLOGICAL DIAGNOSIS WAS RICH. NO ADDITIONAL ADVERSE PATIENT EFFECTS OR PRODUCT PERFORM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1173421 ONYX AGENT, INJECTABLE, EMBOLIC MFE MICRO THERAPEUTICS, INC. DBA EV3 UNK-NV-ONYX UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 1 DA Male Required Intervention