BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PIPELINE

    MDR report key: 5088479 · Received September 18, 2015

    Report

    Report Number
    2029214-2015-05003
    Event Type
    Injury
    Date Received
    September 18, 2015
    Date of Event
    August 25, 2015
    Report Date
    September 1, 2015
    Manufacturer
    COVIDIEN (IRVINE)
    Product Code
    OUT
    PMA / PMN Number
    P100018.S004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ARTICLE WEBSITE: +HTTP://CASEREPORTS.BMJ.COM/CONTENT/2015/BCR-2015-011786.LONG OFF LABEL USE: TREATMENT OF CAROTID¿CAVERNOUS FISTULA. PER INSTRUCTION FOR USE: THE PIPELINE¿ EMBOLIZATION DEVICE (PED) IS INDICATED FOR THE ENDOVASCULAR TREATMENT OF ADULTS (22 YEARS OF AGE OR OLDER) WITH LARGE OR GIANT WIDE-NECKED INTRACRANIAL ANEURYSMS (IAS) IN THE INTERNAL CAROTID ARTERY FROM THE PETROUS TO THE SUPERIOR HYPOPHYSEAL SEGMENTS. INFORMATION REGARDING THE DEVICE MODEL AND LOT NUMBERS, PATIENT WEIGHT, AND PROCEDURE COMPLICATIONS HAVE BEEN REQUESTED; HOWEVER, THE AUTHORS HAVE INDICATED THAT THE INFORMATION CANNOT BE PROVIDED. THE DEVICE WILL NOT BE RETURNED FRO 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 POST PROCEDURE COMPLICATION.

    Description of Event or Problem · 1

    MEDTRONIC (COVIDIEN) RECEIVED INFORMATION FROM LITERATURE REVIEW THAT A PATIENT REQUIRED ANOTHER PIPELINE EMBOLIZATION DEVICE (PED) PLACEMENT FOUR MONTHS AFTER THE FIRST PED IMPLANT DUE TO PERSISTENT FISTULOUS COMMUNICATION ACROSS THE PETROUS CAVERNOUS JUNCTION. THE PATIENT WAS TREATED FOR A HIGH FLOW, DIRECT LEFT CAROTID-CAVERNOUS FISTULA (CCF). A PED WAS DEPLOYED ACROSS THE PETROUS-VERNOUS CAROTID JUNCTION FROM A TRANSARTERIAL APPROACH. A POST-PROCEDURE ANGIOGRAM SHOWED NEAR COMPLETE RESOLUTION OF THE CCF, WITH A FEW MINOR FISTULOUS CONNECTIONS IN THE PETROUS SEGMENT OF THE INTERNAL CAROTID ARTERY (ICA). FOUR MONTHS LATER, A CEREBRAL ANGIOGRAM SHOWED PERSISTENT FISTULOUS COMMUNICATION ACROSS THE PETROUS CAVERNOUS JUNCTION-APED WAS DEPLOYED INTO THE LEFT M1 SEGMENT OF THE MIDDLE CEREBRAL ARTERY IN ORDER TO TREAT THIS ABNORMAL COMMUNICATION. SEVEN MONTHS LATER, A REPEAT ANGIOGRAM SHOWED A COMPLETELY REMODELED ICA AND OCCLUSION OF THE CCF. CITATION: PRADEEP N, NOTTINGHAM R, KAM A, ET AL. TREATMENT OF POST-TRAUMATIC CAROTID-CAVERNOUS FISTULAS USING PIPELINE EMBOLIZATION DEVICE ASSISTANCE. BMJ CASE REP. 2015 AUG 25;2015. PII: BCR2015011786. DOI: 10.1136/BCR-2015-011786.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    618239 PIPELINE INTRACRANIAL ANEURYSM FLOW DIVERTER OUT COVIDIEN (IRVINE) PIPELINE ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 00023 YR Required Intervention