BEUDAMED
    FDA Adverse Event Death Summary report: N

    MARATHON MICROCATHETER

    MDR report key: 6574458 · Received May 17, 2017

    Report

    Report Number
    2029214-2017-00662
    Event Type
    Death
    Date Received
    May 17, 2017
    Date of Event
    March 23, 2017
    Report Date
    April 25, 2017
    Manufacturer
    COVIDIEN (IRVINE)
    Product Code
    KRA
    PMA / PMN Number
    K093750
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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

    CITATION: WOJCIECH PONCYLJUSZ, MARCIN SAWICKI, KATARZYNA LUBKOWSKA, MONIKA RAC. EARLY OUTCOMES AND PERIPROCEDURAL COMPLICATIONS OF T RANSARTERIAL EMBOLIZATION OF BRAIN ARTERIOVENOUS MALFORMATIONS WITH ONYX. POLISH NEUROLOGICAL SOCIETY. 2017. ACCEPTED 23 MARCH 2017. THE AIM OF THE STUDY WAS TO ASSESS THE EFFICACY AND SAFETY OF ENDOVASCULAR TREATMENT OF BAVM WITH ONYX BY REPORTING ONE-CENTER EXPER IENCE. BETWEEN 2006 AND 2013, 54 PATIENTS WITH BAVM WERE EMBOLIZED WITH ONYX. 108 PROCEDURES WERE PERFORMED. THE GROUP CONSISTED OF 24 MALES AND 30 FEMALES, AGED 10 TO 65 YEARS (MEAN 42.6+/- 15.4). CLINICAL MANIFESTATIONS OF BAVMS WERE: HEMORRHAGE IN 27 (50.0%), HEADACHES IN 12 (22.2%), SEIZURES IN 7 (13.0%) AND FOCAL NEUROLOGIC DEFICITS IN 2 (3.7%) PATIENTS. SIX (11.1%) PATIENTS WERE ASYMPTOMATIC. A MAJORITY OF BAVMS WERE OF II AND III GRADE IN SPETZLER-MARTIN SCALE (19 AND 22 CASES RESPECTIVELY). THE DEVICE WAS NOT RETURNED FOR ANALYSIS; THEREFORE THE EVENT CAUSE COULD NOT BE RELIABLY DETERMINED. IT IS POSSIBLE THAT THERE MIGHT HAVE BEEN SIGNIFICANT REFLUX WHICH MAY LED TO THE REPORTED ISSUE. PER OUR INSTRUCTIONS FOR USE (IFU): ¿DIFFICULT CATHETER REMOVAL OR CATHETER ENTRAPMENT MAY BE CAUSED BY ONE OR MORE OF THE FOLLOWING FACTORS: LONG CATHETERIZATION TIME; ANGIO-ARCHITECTURE (VERY DISTAL ARTERIOVENOUS MALFORMATION FED BY AFFERENT, LENGTHENED, SMALL, OR TORTUOUS PEDICLES); VASOSPASM; REFLUX; INJECTION TIME. TO REDUCE THE RISK OF CATHETER ENTRAPMENT, CAREFULLY SELECT CATHETER PLACEMENT AND MANAGE REFLUX TO MINIMIZE THE FACTORS LISTED ABOVE. ONYX LES REFLUX ALONG THE DISTAL TIP OF THE MICRO CATHETER: APART FROM THE RISK OF ISCHEMIC COMPLICATIONS DUE TO UNINTENDED EMBOLIZATION, SIGNIFICANT REFLUX MAY RESULT IN ENTRAPMENT OF THE MICRO CATHETER CAUSING DIFFICULT REMOVAL. THE AMOUNT OF REFLUX THAT CAN BE ACCEPTED MUST ALWAYS BE COMPARED TO THE ANGIO-ARCHITECTURE OF THE MALFORMATION TO MINIMIZE RISK OF UNINTENDED EMBOLIZATION OR DIFFICULT CATHETER REMOVAL. IN GENERAL, MINIMIZE THE REFLUX TO LESS THAN 1 CM ALONG THE DISTAL TIP OF THE MICRO CATHETER. ALL OTHER FACTORS MAY AFFECT THIS LIMIT. SHOULD CATHETER REMOVAL BECOME DIFFICULT, THE FOLLOWING TECHNIQUE MAY ASSIST IN CATHETER RETRIEVAL: CAREFULLY PULL THE CATHETER TO ASSESS ANY RESISTANCE TO REMOVAL; IF RESISTANCE IS FELT, REMOVE ANY ¿SLACK¿ IN THE CATHETER; GENTLY APPLY TRACTION TO THE CATHETER (APPROXIMATELY 3-4 CM OF STRETCH TO THE CATHETER); HOLD THIS TRACTION FOR A FEW SECONDS AND RELEASE; ASSESS TRACTION ON VASCULATURE TO MINIMIZE RISK OF HEMORRHAGE; THIS PROCESS CAN BE REPEATED INTERMITTENTLY UNTIL CATHETER IS RETRIEVED; WHEN USING EV3 MICRO CATHETERS, DO NOT APPLY MORE THAN 20 CM OF TRACTION TO CATHETER, TO MINIMIZE RISK OF CATHETER SEPARATION. FOR ENTRAPPED CATHETERS: UNDER SOME DIFFICULT CLINICAL SITUATIONS, IT MAY SAFER TO LEAVE A FLOW-DIRECTED CATHETER IN THE VASCULAR SYSTEM, RATHER THAN RISK RUPTURING THE MALFORMATION AND, CONSEQUENTLY A HEMORRHAGE, BY EXERCISING TOO MUCH TRACTION ON AN ENTRAPPED CATHETER; THIS IS ACCOMPLISHED BY STRETCHING THE CATHETER AND CUTTING THE SHAFT NEAR THE ENTRY POINT OF VASCULAR ACCESS ALLOWING THE CATHETER TO REMAIN IN THE ARTERY; IF CATHETER BREAKS DURING REMOVAL, DISTAL MIGRATION OR COILING OF THE CATHETER MAY OCCUR; SAME DAY SURGICAL RESECTION SHOULD BE CONSIDERED TO MINIMIZE RISK OF THROMBOSIS.¿ ADDITIONAL INFORMATION HAS BEEN REQUESTED ON THIS EVENT, HOWEVER NO INFORMATION HAS BEEN PROVIDED. SHOULD IT BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED ON THIS EVENT, HOWEVER NO INFORMATION HAS BEEN PROVIDED. SHOULD IT BECOME AVAILABLE, A SU PPLEMENTAL REPORT WILL BE SUBMITTED. MDRS FROM THIS LITERATURE REVIEW: 2029214-2017-00661, 2029214-2017-00662 2029214-2017-00663, 2029214-2017-00664.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION THROUGH LITERATURE REVIEW THAT IN 108 PROCEDURES PERFORMED ON 54 PATIENTS, 1 PATIENT EXPERIENCED A SUB ARACHNOID HEMORRHAGE (SAH) FROM A TEARING OF THE FEEDING PEDICLE DURING RETRIEVAL OF THE TRAPPED MARATHON MICROCATHETER AND LATER DIED. THE PATIENT PRESENTED WITH A CEREBELLAR AVM. THE NIDUS WAS 3CM, PLEXIFORM, WITH 1 FEEDER (RIGHT PCA) AND 1 DRAINING VEIN. DURING THE PROCEDURE, THE PATIENT EXPERIENCED A SAH DUE TO TEARING OF THE FEEDING PEDICLE DURING RETRIEVAL OF A TRAPPED MICROCATHETER. THE SAH INDUCED REFRACTORY CEREBRAL EDEMA WHICH WAS RESISTANT TO TREATMENT. DECOMPRESSIVE CRANIECTOMY WAS PERFORMED, HOWEVER THE PATIENT DIED DUE IN THE FOLLOWING DAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    352718 MARATHON MICROCATHETER CATHETER, CONTINUOUS FLUSH KRA COVIDIEN (IRVINE) UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Death