BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PIPELINE

    MDR report key: 9905961 · Received March 31, 2020

    Report

    Report Number
    2029214-2020-00312
    Event Type
    Injury
    Date Received
    March 31, 2020
    Report Date
    March 31, 2020
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    OUT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SINCE THE DEVICE WAS NOT RETURNED, WE ARE UNABLE TO PERFORM FURTHER ROOT CAUSE ANALYSIS AND THE EXACT CAUSE OF THE REPORTED EVENT IS UNKNOWN. ALL DEVICES ARE 100% TESTED AND ALL PRODUCTS ARE 100% INSPECTED FOR DAMAGES AND IRREGULARITIES DURING MANUFACTURE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ELSAYED GA, CHAGOYA G, BERNSTOCK JD, ET AL. MAGNETIC RESONANCE IMAGING SAFETY OF RETAINED TIP AND PROTECTIVE COILS AFTER FAULTY DEPLOYMENT OF AN INTRACRANIAL PIPELINE EMBOLIZATION DEVICE: A CASE REPORT. WORLD NEUROSURGERY. 2019;129:221-224. DOI:10.1016/J.WNEU.2019.06.007. THE CASE IN THIS ARTICLE WAS REGARDING (B)(6) YEAR OLD FEMALE WITH A RUPTURED VERTEBRAL ARTERY FUSIFORM ANEURYSM JUST DISTAL TO THE ORIGIN OF THE POSTERIOR INFERIOR CEREBELLAR ARTERY. THE RUPTURE LED TO HYDROCEPHALUS AND SUBARACHNOID HEMORRHAGE FOR THE PATIENT. IT WAS REPORTED THAT, DURING PROCEDURE. ONLY MINIMAL TORQUING OF THE DELIVERY SYSTEM WAS REQUIRED TO DISENGAGE THE DISTAL PIPELINE, BUT THE TIP AND PROTECTIVE COIL FRAGMENTED FROM THE DELIVERY WIRE DURING DEPLOYMENT. THIS WAS NOTICED WHEN THE DELIVERY MICROCATHETER WAS ADVANCED OVER THE DELIVERY WIRE AFTER THE DEPLOYMENT. ATTEMPTS TO RETRIEVE THE CAPTURE COIL WERE UNSUCCESSFUL, AND IT REMAINED WITHIN THE P1 SEGMENT OF THE RIGHT PCA. THERE WERE NO OTHER COMPLICATIONS AT THE CONCLUSION OF THE PROCEDURE. THE DEVICE FRAGMENTS REMAINED IN THE PATIENT. POSTPROCEDURE THE PATIENT¿S NEUROLOGIC CONDITION IMPROVED. HOWEVER, AS THE PATIENT BECAME MORE ALERT, A NEW ONSET OF A LEFT UPPER EXTREMITY PARESIS WAS SEEN. 21 DAYS POST PROCEDURE THE PATIENT WAS FOLLOWING COMMANDS AND THEIR LEFT UPPER EXTREMITY PARESIS STARTED TO IMPROVE. THEY WERE ULTIMATELY DISCHARGED TO A REHABILITATION FACILITY, WITH PLANS FOR FOLLOW-UP IMAGING AT 3 MONTHS, BUT DID NOT SHOW DUE TO RELOCATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    370683 PIPELINE INTRACRANIAL ANEURYSM FLOW DIVERTER OUT MICRO THERAPEUTICS, INC. DBA EV3

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Other