BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PIPELINE EMBOLIZATION DEVICE

    MDR report key: 5719510 · Received June 12, 2016

    Report

    Report Number
    2029214-2016-00389
    Event Type
    Injury
    Date Received
    June 12, 2016
    Date of Event
    November 20, 2015
    Report Date
    May 23, 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 MODEL AND LOT NUMBERS WERE NOT REPORTED. THE 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. 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

    ADDITIONAL INFORMATION MDRS RELATED TO THIS ARTICLE: 2029214-2016-00389 2029214-2016-00848 2029214-2016-00849 2029214-2016-00850.

    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 FROM LITERATURE THAT PATIENTS EXPERIENCED STENT 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. TWO PATIENTS SHOWED COMPLETE STENT OCCLUSION ON FOLLOW UP WITHOUT CLINICAL CONSEQUENCES. BOTH CASES WERE DUE TO ANTIPLATELET MEDICATION NONCOMPLIANCE - THE PATIENTS 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
    373904 PIPELINE EMBOLIZATION DEVICE INTRACRANIAL ANEURYSM FLOW DIVERTER OUT COVIDIEN (IRVINE) FA-71500-25 9721318

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Other