BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PIPELINE FLEX

    MDR report key: 6106484 · Received November 16, 2016

    Report

    Report Number
    2029214-2016-01029
    Event Type
    Injury
    Date Received
    November 16, 2016
    Date of Event
    October 19, 2016
    Report Date
    October 19, 2016
    Manufacturer
    MEDTRONIC COVIDIEN
    Product Code
    OUT
    PMA / PMN Number
    P100018.S011
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR EVALUATION AS IT REMAINS IN THE PATIENT; WITHOUT RETURN OF THE DEVICE, NO DEFINITIVE CONCLUSIONS CAN BE DRAWN REGARDING THE CLINICAL OBSERVATION. MDRS RELATED TO THIS REPORT: 2029214-2016-01026, 2029214-2016-01027, 2029214-2016-01028. 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

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION THAT DURING TREATMENT OF AN ANEURYSM LOCATED IN THE LEFT INTERNAL CAROTID ARTERY (ICA), THREE DEVICES WERE LAZY TO OPEN AND A FOURTH DEVICE HAD SOME NARROWING. IT WAS REPORTED THAT THE MIDDLE SECTION OF THE FIRST DEVICE (PED-500-30; LOT A120624) FAILED TO OPEN AS THE PROXIMAL SECTION WAS POSITIONED IN A BEND. LESS THAN 50% OF THE DEVICE WAS DEPLOYED WHEN IT FAILED TO OPEN. THE DEVICE WAS RESHEATHED MORE THAN 2 TIMES AND REMOVED FROM THE PATIENT, WITH THE MICROCATHETER. A SECOND PIPELINE (PED-500-30; LOT A120624) WAS ATTEMPTED AND THE DISTAL SECTION FAILED TO OPEN AS THE PIPELINE MIDDLE SECTION WAS POSITIONED IN A BEND. LESS THAN 50 % OF THIS DEVICE WAS DEPLOYED WHEN IT FAILED TO OPEN. THE DEVICE WAS RESHEATHED MORE THAN 2 TIMES AND WITHDRAWN WITH THE MICROCATHETER. A THIRD DEVICE WAS ATTEMPTED, THIS DEVICE (PED-475-30; A066386) MIDDLE SECTION DID NOT OPEN AS THE MIDDLE SECTION WAS POSITIONED IN A BEND. LESS THAN 50 % OF THIS DEVICE WAS DEPLOYED WHEN IT FAILED TO OPEN. THE DEVICE WAS RESHEATHED MORE THAN TWO TIMES AND REMOVED FROM THE PATIENT WITH THE MICROCATHETER. A NEW MICROCATHETER WAS USED IN TWO OF THE THREE DELIVERIES. EVENTUALLY THE FOURTH DEVICE (PED-475-30; LOT NUMBER UNKNOWN) WAS SUCCESSFULLY IMPLANTED; HOWEVER, THE DEVICE DID SHOW SOME NARROWING AT THE DISTAL THIRD OF THE DEVICE. APPROXIMATELY AN HOUR AFTER THE IMPLANT THE PATIENT WAS EXPERIENCED STROKE LIKE SYMPTOMS AND WAS BROUGHT BACK TO THE LAB FOR DIAGNOSTIC ANGIOGRAM. THE ANGIOGRAM REVEALED COMPLETE ICA OCCLUSION FROM THE BIFURCATION OF THE EXTERNAL ICA TO THE M1 M2 SEGMENTS. DEVICE WAS APPOSED DISTAL AND PROXIMAL. MID SECTION WAS SLIGHTLY NARROWED (NOT FLOW RESTRICTIVE). SOME CONTRAST STAGNATION WAS OBVIOUS. THE ANEURYSM WAS UNRUPTURED AND SACCULAR. THE MAX DIAMETER WAS 10 MM AND THE NECK DIAMETER WAS 6 MM. THE DISTAL LANDING ZONE WAS UNKNOWN, AND THE PROXIMAL LANDING ZONE WAS 4.8 MM. THE PATIENT HAD MODERATE VESSEL TORTUOSITY. DAPT WAS ADMINISTERED, AND PRU LEVEL WAS NOTED AS THERAPEUTIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    756930 PIPELINE FLEX INTRACRANIAL ANEURYSM FLOW DIVERTER OUT MEDTRONIC COVIDIEN PED-475-30

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Other