BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NV MICROCATHETER

    MDR report key: 6517633 · Received April 24, 2017

    Report

    Report Number
    2029214-2017-00530
    Event Type
    Injury
    Date Received
    April 24, 2017
    Date of Event
    May 31, 2005
    Report Date
    March 30, 2017
    Manufacturer
    COVIDIEN (IRVINE)
    Product Code
    KRA
    PMA / PMN Number
    K093750
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: DONGLEI SONG, BING LENG,YUXIANG GU, WEI ZHU, BIN XU, XIECHENG CHEN, LIANGFU ZHOU. CLINICAL ANALYSIS OF 50 CASES OF BAVM EMBOLIZATION WITH ONYX, A NOVEL LIQUID EMBOLIC AGENT. INTERVENTIONAL NEURORADIOLOGY 11: 179-184, 2005 THE PURPOSE OF THIS ARTICLE WAS TO STUDY THE EMBOLIZATION TECHNIQUE USING ONYX TO TREAT CEREBRAL ARTERIOVENOUS MALFORMATIONS (AVMS), AS WELL AS THE EFFICACY. THE AUTHORS CONCLUDE THAT ONYX HAS A UNIQUE AND DISTINCTIVE SUPERIORITY IN TREATING CEREBRAL AVMS. BETWEEN SEPTEMBER 2003 AND MAY 2005, 50 PATIENTS WITH BAVMS WERE TREATED. THERE WERE 35 MEN AND 15 FEMALE PATIENTS WITH A MEAN AGE OF 28 YEARS (RANGE 12-47 YEARS). THERE IS LIMITED PATIENT AND DEVICE INFORMATION AVAILABLE WITHIN THIS ARTICLE. THE MODELS AND LOT NUMBERS WERE NOT CAPTURED OR REPORTED. WITHIN THE ARTICLE, THERE WAS NO CONFIRMED DEFECTS OR DEVICE DEFICIENCY. THE ARTICLE NOTED THAT BOTH THE ULTRAFLOW AND MARATHON WERE USED IN THE PROCEDURES, HOWEVER, WHICH OF THESE DEVICES USED IN THE INDIVIDUAL CASES WAS UNKNOWN. HEMORRHAGE AND VESSEL PERFORATION ARE KNOWN INHERENT RISKS OF THE PROCEDURE AND ARE NOTED UNDER POTENTIAL COMPLICATIONS IN THE ONYX, ULTRAFLOW, AND MARATHON INSTRUCTIONS FOR USE (IFUS). THE ONYX INSTRUCTIONS FOR USE (IFU) NOTES, ¿DO NOT ALLOW MORE THAN 1 CM OF ONYX¿ LES TO REFLUX BACK OVER CATHETER TIP. ANGIO-ARCHITECTURE, VASOSPASM, EXCESSIVE ONYX REFLUX, OR PROLONGED INJECTION TIME MAY RESULT IN DIFFICULT CATHETER REMOVAL AND CATHETER ENTRAPMENT. EXCESSIVE FORCE TO REMOVE AN ENTRAPPED CATHETER MAY CAUSE SERIOUS INTRACRANIAL HEMORRHAGE.¿ THE MARATHON AND ULTRAFLOW INSTRUCTIONS FOR USE BOTH ADVISE, ¿NEVER ADVANCE OR WITHDRAW AN INTRALUMINAL DEVICE AGAINST RESISTANCE UNTIL THE CAUSE OF THE RESISTANCE IS DETERMINED BY FLUOROSCOPY. EXCESSIVE FORCE AGAINST RESISTANCE MAY RESULT IN DAMAGE TO THE DEVICE OR VESSEL PERFORATION.¿ BASED ON THE REPORTED INFORMATION PER THE REPORTED INFORMATION, REVIEW OF IFUS, AND REVIEW OF LITERATURE TO INVESTIGATE THE COMPLAINT, THE MOST LIKELY CAUSE FOR THE REPORTED EVENTS IS PROCEDURE RELATED. ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM THE AUTHOR OF THE ARTICLE. SHOULD IT BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. MDRS FROM THIS EVENT: 2029214-2017-00529, 2029214-2017-00530 MDRS FROM THIS LITERATURE REVIEW: 2029214-2017-00531, 2029214-2017-00532, 2029214-2017-00533. 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.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION THROUGH LITERATURE REVIEW THAT 9 PATIENTS EXPERIENCED HEMORRHAGES (3 SEVERE, 6 ASYMPTOMATIC). WHEN RECEIVING ONYX EMBOLIZATION TREATMENT FOR BAVMS, 3 PATIENTS EXPERIENCED SEVERE BRAIN HEMORRHAGES, AND UNDERWENT EMERGENCY SURGERY TO REMOVE THE HEMATOMA. ONE OF THE HEMORRHAGES WAS CAUSED BY PERFORATION OF THE SMALL TORTUOUS FEEDER BY THE MICROCATHETER DURING THE PROCEDURE; THE OTHER 2 WERE CAUSED BY OBVIOUS SHIFTING OF THE NIDUS WHEN THE MICROCATHETER WAS WITHDRAWN AT THE END OF THE EMBOLIZATION PROCEDURE. ONE OF THE PATIENTS WAS FULLY RECOVERED WHEN DISCHARGED. THE OTHER TWO WERE LEFT WITH HEMIPLEGIA. ADDITIONALLY, 6 PATIENTS WITH HIGHER PERCENTAGE OF EMBOLIZATION WERE FOUND ASYMPTOMATIC OR MINOR SAH OR VENTRICULAR HEMORRHAGE. THE 6 PATIENTS RECOVERED AFTER EXPECTANT TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    299075 NV MICROCATHETER CATHETER, CONTINUOUS FLUSH KRA COVIDIEN (IRVINE) UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Other| S