BEUDAMED
    FDA Adverse Event Death Summary report: N

    PIPELINE FLEX EMBOLIZATION DEVICE

    MDR report key: 6130989 · Received November 29, 2016

    Report

    Report Number
    2029214-2016-01073
    Event Type
    Death
    Date Received
    November 29, 2016
    Date of Event
    August 25, 2016
    Report Date
    November 1, 2016
    Manufacturer
    COVIDIEN (IRVINE)
    Product Code
    OUT
    PMA / PMN Number
    P100018.S011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PIPELINE DEVICE WILL NOT BE RETURNED FOR EVALUATION AS IT WAS IMPLANTED IN THE PATIENT. BASED ON THE REPORTED INFORMATION, THERE DID NOT APPEAR TO HAVE BEEN ANY DEFECT OF THE DEVICE DURING USE. THE EVENT OCCURRED IN THE PATIENT POST-PROCEDURE AND ITS CAUSE COULD NOT BE CONCLUSIVELY DETERMINED FROM THE REPORTED INFORMATION. MAZUR, M. D. (2016, AUGUST 25). RERUPTURE OF A BLISTER ANEURYSM AFTER TREATMENT WITH A SINGLE FLOW-DIVERTING STENT. NEUROSURGERY, 79(5), E634-E638. DOI:10.1227/NEU.0000000000001412 MDRS RELATED TO THIS ARTICLE: 2029214-2016-01072 2029214-2016-01073 2029214-2016-01074. 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

    EXPIRATION DATE, LOT NUMBER, ADDITIONAL INFORMATION, MANUFACTURING DATE - ADDITIONAL INFORMATION. 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

    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.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION FROM LITERATURE THAT A PATIENT EXPERIENCED NEUROLOGICAL DECLINE AFTER PIPELINE FLEX IMPLANTATION. THE PATIENT HAD INITIALLY PRESENTED WITH A THUNDERCLAP HEADACHE, CONFUSION, MILD LEFT-SIDED FACIAL WEAKNESS, AND LEFT PRONATOR DRIFT (HUNT AND HESS GRADE 3). A COMPUTED TOMOGRAPHY (CT) SHOWED THICK DIFFUSE SUBARACHNOID HEMORRHAGE (SAH) (FISHER GRADE 3) AND HYDROCEPHALUS. DIGITAL SUBTRACTION ANGIOGRAPHY DEMONSTRATED A 4.3 X 2.2MM DORSAL VARIANT BLISTER ANEURYSM OF THE RIGHT INTERNAL CAROTID ARTERY (ICA). THE PARENT VESSEL AT THE ANEURYSM SITE MEASURED 5.1MM IN DIAMETER; THE CAVERNOUS ICA MEASURED >6MM IN DIAMETER. THE PATIENT RECEIVED AN EXTERNAL VENTRICULAR DRAIN TO ADDRESS THE HYDROCEPHALUS. A PIPELINE FLEX WAS IMPLANTED TO TREAT THE BLISTER ANEURYSM; NINE DAYS POST-IMPLANTATION, THE PATIENT RECEIVED A SECOND PIPELINE FLEX DUE TO CONCERNS OF RE-RUPTURE. AFTER RETREATMENT, THE PATIENT HAD PERSISTENTLY POOR NEUROLOGICAL STATUS AND REFRACTORY INTRACRANIAL PRESSURE ELEVATIONS DESPITE MAXIMAL MEDICAL MANAGEMENT WITH HYPERTONIC INFUSIONS, SEDATIVES, CEREBROSPINAL FLUID DIVERSION, AND TARGETED COOLING. BECAUSE OF THE PATIENT¿S POOR PROGNOSIS, THE FAMILY DECIDED TO WITHDRAW CARE. THE PATIENT PASSED AWAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    782310 PIPELINE FLEX EMBOLIZATION DEVICE INTRACRANIAL ANEURYSM FLOW DIVERTER OUT COVIDIEN (IRVINE) PED-500-14 A080838

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Death