BEUDAMED
    FDA Adverse Event Death Summary report: N

    PIPELINE EMBOLIZATION DEVICE

    MDR report key: 5992093 · Received September 30, 2016

    Report

    Report Number
    2029214-2016-00848
    Event Type
    Death
    Date Received
    September 30, 2016
    Date of Event
    November 20, 2015
    Report Date
    September 8, 2016
    Manufacturer
    COVIDIEN (IRVINE)
    Product Code
    OUT
    PMA / PMN Number
    P100018.S004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PIPELINE DEVICE WILL NOT BE RETURNED FOR ANALYSIS AS IT WAS IMPLANTED IN THE PATIENT. BASED ON THE REPORTED INFORMATION, THERE IS NO EVIDENCE SUGGESTING THAT THE DEVICE WAS DEFECTIVE. THE CAUSE OF THE EVENT COULD NOT BE CONCLUSIVELY DETERMINED FROM THE REPORTED INFORMATION. MDRS RELATED TO THIS ARTICLE: 2029214-2016-00389, 2029214-2016-00848, 2029214-2016-00849, 2029214-2016-00850. 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 REVIEW OF PATIENT DEATH AFTER PIPELINE IMPLANTATION. THIS WAS RETROSPECTIVE STUDY OF 51 PATIENTS TREATED FOR 57 ANEURYSMS WITH THE PIPELINE EMBOLIZATION DEVICE (PED). THE PATIENTS WERE TREATED FOR RUPTURED AND UNRUPTURED ANEURYSMS LOCATED IN THE INTERNAL CAROTID ARTERY (ICA) (CAVERNOUS, OPHTHALMIC, COMMUNICATING SEGMENTS), ANTERIOR CEREBRAL ARTERY (ACA), BASILAR ARTERY, AND VERTEBRAL ARTERY. THE AVERAGE MEASUREMENT OF THE LARGEST ANEURYSM DIAMETER WAS 11.9MM. A MEAN OF 1.5 PIPELINE DEVICES WERE USED. THE ARTICLE STATED THAT 3 OF THE 80 PATIENTS WERE UNABLE TO UNDERGO FOLLOW-UP ANGIOGRAPHY DUE TO DEATH BEFORE THE FIRST SCHEDULED ANGIOGRAM. THE FIRST FOLLOW-UP ANGIOGRAPHY WAS USUALLY PERFORMED AT 6-MONTHS POST-TREATMENT. ONE PATIENT REPORTEDLY EXPERIENCED A STROKE WHILE IN REHABILITATION, CODED DURING MRI, AND PASSED AWAY. THE OTHER TWO PATIENTS PASSED AWAY DUE FOR REASONS UNRELATED TO THE PIPELINE DEVICE OR PROCEDURE (HEPATIC ANEURYSM RUPTURE, MULTIPLE MEDICAL PROBLEMS AND FAILURE TO THRIVE) CITATION: JOHN, S. ET AL. (2016). LONG-TERM FOLLOW-UP OF IN-STENT STENOSIS AFTER PIPELINE FLOW DIVERSION TREATMENT OF INTRACRANIAL ANEURYSMS. NEUROSURGERY, 78(6), 862-867. DOI:10.1227/NEU.0000000000001146.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    642536 PIPELINE EMBOLIZATION DEVICE INTRACRANIAL ANEURYSM FLOW DIVERTER OUT COVIDIEN (IRVINE)

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Death