BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PIPELINE EMBOLIZATION DEVICE

    MDR report key: 5992097 · Received September 30, 2016

    Report

    Report Number
    2029214-2016-00849
    Event Type
    Injury
    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, BUT RATHER A PROCEDURE RELATED EVENT. OCCLUSION IS A KNOWN INHERENT RISK OF PIPELINE PROCEDURE AND IS DOCUMENTED IN THE PIPELINE INSTRUCTION FOR USE. PER THE ARTICLE, THE PATIENTS EXPERIENCED OCCLUSION DUE TO NONCOMPLIANCE TO ANTIPLATELET MEDICATIONS. MDRS RELATED TO THIS ARTICLE: 2029214-2016-00389 2029214-2016-00848 2029214-2016-00849 2029214-2016-00850.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION FROM LITERATURE OF OCCLUSION AFTER PIPELINE EMBOLIZATION DEVICE 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. IT WAS REPORTED THAT THE PATIENT EXPERIENCED STENT OCCLUSION ON FOLLOW UP WITHOUT CLINICAL CONSEQUENCES. THE STENT OCCLUSION WAS REPORTEDLY DUE TO ANTIPLATELET MEDICATION NONCOMPLIANCE - THE PATIENT HAD DISCONTINUED MEDICATIONS. 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
    642541 PIPELINE EMBOLIZATION DEVICE INTRACRANIAL ANEURYSM FLOW DIVERTER OUT COVIDIEN (IRVINE) FA-77325-14 9690268

    Patients

    Seq Age Sex Outcome Treatment
    1 Other