BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HYPERGLIDE

    MDR report key: 6441253 · Received March 28, 2017

    Report

    Report Number
    2029214-2017-00255
    Event Type
    Injury
    Date Received
    March 28, 2017
    Date of Event
    February 29, 2012
    Report Date
    March 2, 2017
    Manufacturer
    COVIDIEN (IRVINE)
    Product Code
    MJN
    PMA / PMN Number
    K021066
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED ANALYSIS. ATTEMPTS TO OBTAIN SPECIFIC DETAILS HAVE BEEN MADE. HOWEVER, OUR ATTEMPTS HAVE BEEN UNSUCCESSFUL. BASED ON THE REPORTED INFORMATION, THERE IS NO EVIDENCE THAT THE DEVICE WAS DEFECTIVE OR MALFUNCTIONED. THE IATROGENIC CAROTID DISSECTION, THE VESSEL PERFORATION, THE THROMBI, AND HEMORRHAGES ARE KNOWN INHERENT RISK OF MECHANICAL THROMBECTOMY PROCEDURE AND ARE DOCUMENTED IN OUR DEVICE¿S INSTRUCTION FOR USE (IFU). THESE EVENTS COULD NOT BE CONFIRMED, AS THE CAUSE COULD NOT BE DEFINITIVELY DETERMINED.

    Description of Event or Problem · 1

    CITATION: INTRA-ARTERIAL THROMBOLYSIS USING DOUBLE DEVICES: MECHANICOMECHANICAL OR CHEMICOMECHANICAL TECHNIQUES. PARK H1, HWANG GJ, JIN SC, BANG JS, OH CW, KWON OK. J KOREAN NEUROSURG SOC. 2012 FEB;51(2):75-80. THREE PROCEDURE-RELATED COMPLICATIONS DEVELOPED IN 3 PATIENTS: IATROGENIC CAROTID DISSECTION, CEREBRAL ARTERY (M2) PERFORATION AND THROMBI AT THE OPHTHALMIC ARTERY. THE CAROTID DISSECTION WAS SUCCESSFULLY TREATED WITH A STENT. BLOOD LEAKAGE FROM THE M2 PERFORATION WAS CONTROLLED WITH A TEMPORARY M2 OCCLUSION WITH PLATINUM COILS. THE OPHTHALMIC ARTERY THROMBUS WAS RESOLVED BY INFUSION OF A THROMBOLYTIC AGENT. RECOVERY FROM THESE COMPLICATIONS WAS CONFIRMED BY FOLLOW-UP ANGIOGRAMS. POST-PROCEDURAL HEMORRHAGE WAS DETECTED ON CT IN FIVE PATIENTS. OF THESE, 2 PATIENTS WERE SYMPTOMATIC. ONE PATIENT, WHO HAD A CEREBELLAR HEMORRHAGE, UNDERWENT DECOMPRESSIVE SURGERY BECAUSE OF BRAIN STEM COMPRESSION AND HAD A MRS AT 90 DAYS OF 5. THE OTHER PATIENT RECEIVED CONSERVATIVE MANAGEMENT AND HAD A MRS AT 90 DAYS OF 4.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    222324 HYPERGLIDE CATHETER, INTRAVASCULAR OCCLUDING, TEMPORARY MJN COVIDIEN (IRVINE)

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention