BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NV MICROCATHETER

    MDR report key: 6517107 · Received April 24, 2017

    Report

    Report Number
    2029214-2017-00501
    Event Type
    Injury
    Date Received
    April 24, 2017
    Date of Event
    October 28, 2010
    Report Date
    March 28, 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: FENG XU, WEI NI, YUJUN LIAO, YUXIANG GU, BIN XU, BING LENG, DONGLEI SONG. ONYX EMBOLIZATION FOR THE TREATMENT OF BRAIN ARTERIOVENOUS MALFORMATIONS. ACTA NEUROCHIR (2011). PUBLISHED ONLINE: 28 OCTOBER 2010 THE PURPOSE OF THIS ARTICLE WAS TO STUDY THE EXPERIENCE IN THE TREATMENT OF BRAIN AVMS WITH ONYX EMBOLIZATION. BETWEEN JANUARY 2004 AND DECEMBER 2007, 86 PATIENTS WITH BRAIN AVMS WERE EMBOLIZED WITH ONYX. THE AUTHORS CONCLUDE THAT ALTHOUGH ONYX ALLOWS MODERATE OBLITERATION RATES, COMBINED MANAGEMENT, SUCH AS ADJUNCTIVE EMBOLIZATION WITH MICROSURGERY OR RADIOSURGERY, MAY BE EFFECTIVE FOR SELECTED LARGE AVMS. THE MEAN PATIENT AGE WAS 30.3 YEARS (RANGE, 8¿55 YEARS). THERE WERE 51 MEN AND 35 WOMEN. THE REPORTED DEVICE IS EITHER THE MARATHON MICROCATHETER OR ULTRAFLOW MICROCATHETER. THE PRODUCTS WERE NOT RETURNED FOR EVALUATION AS THIS WAS AN EVENT CAPTURED THROUGH LITERATURE REVIEW. THE PRODUCTS WERE NOT RETURNED FOR EVALUATION AS THIS WAS AN EVENT CAPTURED THROUGH LITERATURE REVIEW. THERE IS LIMITED PATIENT, PROCEDURE AND DEVICE INFORMATION AVAILABLE; IN THIS ARTICLE IT WAS REPORTED THAT BOTH THE MARATHON AND ULTRAFLOW MICROCATHETERS WERE USED. IT WAS NOT REPORTED WHICH MICROCATHETER WAS USED IN THIS PROCEDURE. BOTH THE ULTRAFLOW AND MARATHON INSTRUCTIONS FOR USE (IFU) ADVISE, "SHOULD CATHETER REMOVAL BECOME DIFFICULT, THE FOLLOWING WILL ASSIST IN CATHETER RETRIEVAL. ASSESS THE FOLLOWING PARAMETERS BY OBSERVING THE DISTAL SHAFT OF THE CATHETER: ¿¿ VESSEL STRAIGHTENING ¿¿ TRACTION ON EMBOLIC CAST ¿¿ CATHETER TIP RELEASING FROM EMBOLIC CAST." HEMORRHAGE IS A KNOWN INHERENT RISK OF THIS PROCEDURE AND IS DOCUMENTED IN BOTH THE ULTRAFLOW AND MARATHON IFUS. BASED ON THE REPORTED INFORMATION, REVIEW OF IFUS, AND REVIEW OF LITERATURE TO INVESTIGATE THE COMPLAINT, THE MOST LIKELY CAUSE FOR THE REPORTED EVENT IS PROCEDURE RELATED. ADDITIONAL INFORMATION HAS BEEN REQUESTED ON EACH CASE; SHOULD THE INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WI LL BE SUBMITTED. MDRS FROM THIS EVENT: 2029214-2017-00501, 2029214-2017-00502 MDRS FROM THIS LITERATURE REVIEW: 2029214-2017-00493, 2029214-2017-00494, 2029214-2017-00495, 2029214-2017-00496, 2029214-2017-00497, 2029214-2017-00498, 2029214-2017-00499, 2029214-2017-00500, AND 2029214-2017-00503.

    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 A SEVERE INTRACEREBRAL HEMORRHAGE OCCURRED IN ONE PATIENT, WHICH WAS CAUSED BY SHIFTING OF THE NIDUS DURING MICROCATHETER RETRIEVAL. THE PATIENT UNDERWENT A CRANIOTOMY FOR HEMATOMA EVACUATION AND REMOVAL OF THE MALFORMATION. HOWEVER, THE PATIENT WAS LEFT WITH DISABLING HEMIPARESIS. AT THE FOLLOW-UP, THE PATIENT¿S CONDITION WAS IMPROVED TO A NON-DISABLING RESIDUAL HEMIPARESIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    298351 NV MICROCATHETER CATHETER, CONTINUOUS FLUSH KRA COVIDIEN (IRVINE) UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Required Intervention| S