BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PIPELINE EMBOLIZATION DEVICE

    MDR report key: 4220600 · Received November 3, 2014

    Report

    Report Number
    2029214-2014-00608
    Event Type
    Malfunction
    Date Received
    November 3, 2014
    Date of Event
    September 30, 2014
    Report Date
    December 15, 2017
    Manufacturer
    COVIDIEN
    Product Code
    OUT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE EVENT HAS NOT BEEN RETURNED FOR EVALUATION.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: DEVICE EVALUATED. ADDITIONAL MANUFACTURER NARRATIVE: DEVICE EVALUATION: THE PIPELINE DELIVERY SYSTEM WAS RETURNED FOR EVALUATION AND THE CLINICAL OBSERVATION COULD NOT BE CONFIRMED AND THE EVENT CAUSE COULD NOT BE DETERMINED AS THE RETURNED PIPELINE BRAID WAS FOUND FULLY OPENED AT BOTH ENDS. THE PIPELINE BRAID WAS RETURNED DETACHED FROM THE PUSHWIRE; THEREFORE, THE DISTAL AND PROXIMAL ENDS OF THE BRAID WERE UNABLE TO BE IDENTIFIED. BOTH ENDS OF THE PIPELINE BRAID WERE FOUND FULLY OPENED WITH NO DAMAGE. NO BENDS WERE FOUND ON THE PUSHWIRE. NO DEFECTS WERE FOUND WITH THE TIP COIL, CAPTURE COIL OR PROXIMAL BUMPER. NO OTHER ANOMALIES WERE OBSERVED. POSSIBLE CONTRIBUTING FACTOR TO THE REPORTED EVENT INCLUDE VESSEL TORTUOSITY. HOWEVER, THE PATIENT ANATOMY WAS NOT REPORTED. PER OUR INSTRUCTIONS FOR USE (IFU): ¿BEGIN TO DELIVER THE DEVICE USING A COMBINATION OF UNSHEATHING THE PIPELINE FLEX EMBOLIZATION DEVICE AND PUSHING DELIVERY WIRE SIMULTANEOUSLY. AFTER THE DISTAL END OF THE PIPELINE FLEX EMBOLIZATION DEVICE HAS SUCCESSFULLY EXPANDED, DEPLOY THE REMAINDER OF PIPELINE FLEX EMBOLIZATION DEVICE BY PUSHING THE DELIVERY WIRE AND/OR UNSHEATHING THE PIPELINE FLEX EMBOLIZATION DEVICE. RE-SHEATHING AND/OR MANIPULATION OF THE MICRO CATHETER, BY LOCKING DOWN THE DELIVERY WIRE AND MOVING BOTH AS A SYSTEM, MAY FACILITATE EXPANSION OF THE PIPELINE FLEX EMBOLIZATION DEVICE. DO NOT USE IN PATIENTS IN WHOM THE ANGIOGRAPHY DEMONSTRATES THE ANATOMY IS NOT APPROPRIATE FOR ENDOVASCULAR TREATMENT, DUE TO CONDITIONS SUCH AS SEVERE INTRACRANIAL VESSEL TORTUOSITY OR STENOSIS.¿ THE ORIGINAL MDR 2029214-2014-00608 WAS SUBMITTED IN 2014. THE DEVICE HAS JUST BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE PATIENT UNDERWENT PIPELINE EMBOLIZATION TREATMENT INVOLVING TWO PIPELINES. DURING THE PROCEDURE, IT WAS REPORTED THE FIRST PIPELINE (4.50MM X 25MM) COULD NOT BE OPENED AND WAS ALSO HAVING DIFFICULTY ADVANCING IN THE MICROCATHETER. ANOTHER PIPELINE (4.50MM X 20MM) WAS ADVANCED TO THE LESION, BUT ALSO COULD NOT BE OPENED. THERE WAS NO INJURY REPORTED, NO PERMANENT DAMAGE, NO PROLONGED HOSPITAL STAY, AND NO BLEEDING IN EXCESS. NO FURTHER INFORMATION AS PROVIDED. SAME EVENT AS MDR# 2029214-2014-00607.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    703326 PIPELINE EMBOLIZATION DEVICE FLOW DIVERSION OUT COVIDIEN FA-77450-20 9774816

    Patients

    Seq Age Sex Outcome Treatment
    1