BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONYX

    MDR report key: 17657137 · Received August 30, 2023

    Report

    Report Number
    2029214-2023-01547
    Event Type
    Injury
    Date Received
    August 30, 2023
    Date of Event
    September 9, 2020
    Report Date
    November 20, 2023
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    MFE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    G2: CITATION: AUTHORS: MOLINA-NUEVO, J. D., LÓPEZ-MARTÍNEZ, L., PEDROSA-JIMÉNEZ, M. J., JULIÁ-MOLLA, E.. ENDOVASCULAR MANAGEMENT OF AN UNSUAL CASE OF SPONTANEOUS RETROPERITONEAL HAEMORRHAGE DUE TO FIBROMUSCULAR DYSPLASIA. CVIR ENDOVASCULAR 3(1) 2020. DOI:1 0.1186/S42155-020-00157-8. EARLIEST 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.

    Additional Manufacturer Narrative · 0

    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.

    Description of Event or Problem · 0

    MOLINA-NUEVO JD, LÓPEZ-MARTÍNEZ L, PEDROSA-JIMÉNEZ MJ, JULIÁ-MOLLA E. ENDOVASCULAR MANAGEMENT OF AN UNSUAL CASE OF SPONTANEOUS RETROPERITONEAL HAEMORRHAGE DUE TO FIBROMUSCULAR DYSPLASIA. CVIR ENDOVASCULAR. 2020;3(1). DOI:10.1186/S42155-020-00157-8. MEDTRONIC LITERATURE REVIEW FOUND A REPORT OF PATIENT COMPLICATIONS IN ASSOCIATION WITH ONYX LIQUID EMBOLIC. THE PURPOSE OF THIS ARTICLE WAS TO PRESENT AN ATYPICAL CASE OF A FIBROMUSCULAR DYSPLASIA (FMD) PATIENT WITH ACTIVE BLEEDING AND LEFT RENAL ARTERY STENOSIS. THE FOLLOWING INTRA- OR POST-PROCEDURAL OUTCOMES WERE NOTED:  - STENOSIS OF THE LEFT RENAL ARTERY AND FREE PERITONEAL FLUID WERE OBSERVED. AFTER THE SELECTIVE ANGIOGRAPHIC SERIES OF THE LEFT RENAL ARTERY, THE EXISTENCE OF A PROFUSE COLLATERAL VASCULAR NETWORK TO THE ADRENAL GLAND WITH SIGNS OF ACTIVE BLEEDING WAS SEEN. THIS NETWORK COULD BE EMBOLIZED COMPLETELY BY INJECTING ONYX. AFTER THIS, ANOTHER ARTERIAL BRANCH, WHICH ALSO NOURISHED ANOTHER PART OF THIS NETWORK, EVIDENCING SIGNS OF ACTIVE BLEEDING WAS DETECTED. IT WAS EMBOLIZED IN THE SAME WAY BY INJECTING ONYX. FINALLY, AFTER AN EXTENSIVE VASCULAR STUDY CONFIRMING NO OTHER SIGN OF ACTIVE BLEEDING, AN ANGIOPLASTY OF THE LEFT RENAL ARTERY WAS PERFORMED USING A MUSTANG BALLOON CATHETER, WITH MODERATE RECOVERY OF CALIBER. THE PATIENT HAD A FAVORABLE OUTCOME, THOUGH HE HAD A FEVER PEAK OF 37.9 °C (WITH NEGATIVE URINE AND BLOOD CULTURES), SO LEVOFLOXACIN ANTIBIOTIC THERAPY WAS INSTITUTED FOR PREVENTIVE PURPOSES. HE HAD VERY HIGH BLOOD PRESSURE LEVELS, WITH PEAKS UP TO 200 MMHG, REQUIRING ADMINISTRATION OF AMLODIPINE, DOXAZOSIN AND EVEN INTRAVENOUS URAPIDIL PULSES FOR CONTROLLING THEM. GIVEN THIS SITUATION, IT WAS DECIDED TO PERFORM A NEW RENAL ANGIOPLASTY, IN THIS CASE BILATERAL, USING A MUSTANG BALLOON CATHETER OF 6MM× 4 CM ACHIEVING FULL BILATERAL RECOVERY OF THE NORMAL RENAL ARTERY CALIBER. AFTER THIS, THE PATIENT¿S BLOOD PRESSURE LEVELS RETURNED TO NORMAL. THE PATIENT WAS DISCHARGED AT 16 DAYS OF ADMISSION, ASYMPTOMATIC, FEVER-FREE, AND NOT REQUIRING MEDICAL TREATMENT.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS RECEIVED THAT NO ADVERSE EVENTS WITH MEDTRONIC PRODUCTS TOOK PLACE AS CONFIRMED BY THE HCP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1184094 ONYX AGENT, INJECTABLE, EMBOLIC MFE MICRO THERAPEUTICS, INC. DBA EV3 UNK-NV-ONYX UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Male Required Intervention