BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PIPELINE FLEX

    MDR report key: 8075395 · Received November 15, 2018

    Report

    Report Number
    2029214-2018-00942
    Event Type
    Malfunction
    Date Received
    November 15, 2018
    Date of Event
    October 19, 2018
    Report Date
    January 23, 2019
    Manufacturer
    COVIDIEN (IRVINE)
    Product Code
    OUT
    PMA / PMN Number
    P100018.S011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE PIPELINE FLEX WAS RETURNED FOR EVALUATION WITHIN ITS OUTER CARTON; INSIDE OF A SEALED BIOHAZARD PLASTIC BAG AND A SHIPPING BOX. WHEN COMPARED TO THE DRAWING THE DISTAL AND PROXIMAL DPS RESTRAINTS WERE FOUND TO BE INTACT. THE DPS SLEEVES WERE FOUND INTACT WITH NO SIGNS OF DAMAGE. THE DISTAL HYPOTUBE AND PTFE SHRINK TUBING WERE FOUND TO BE INTACT WITH NO SIGNS OF ELONGATION. THE DISTAL AND PROXIMAL ENDS OF THE PIPELINE FLEX BRAID FULLY OPENED AND MODERATELY FRAYED. NO BEND WAS FOUND ON THE PUSHWIRE. NO DAMAGES WERE FOUND WITH THE TIP COIL, DISTAL MARKER, RE-SHEATHING MARKER, RE-SHEATHING PAD OR WITH THE PROXIMAL BUMPER. NO OTHER ANOMALIES WERE OBSERVED. IT IS POSSIBLE THAT THE "PATIENT TORTUOUS ANATOMY" MAY HAVE CONTRIBUTED TO THE FAILURE TO OPEN ISSUE. THE DAMAGE ON BOTH ENDS OF THE PIPELINE FLEX BRAID IS LIKELY THE RESULT OF THE CUSTOMER RE-SHEATHING THE DEVICE MORE THAN RECOMMENDED TWO TIMES. MEDTRONIC, INC. (MEDTRONIC) IS SUBMITTING THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE MEDICAL DEVICE REPORTING REGULATION. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION IN THE TIME ALLOTTED AND HAS PROVIDED AS MUCH INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY "DEFECTS" OR HAS "MALFUNCTIONED". THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA, TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REPORTING PURSUANT TO PART 803. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE IT BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. 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

    THE PIPELINE FLEX DEVICE HAS NOT BEEN RETURNED FOR EVALUATION; PRODUCT ANALYSIS CANNOT BE PERFORMED. THE DEVICE WAS NOT RETURNED, THEREFORE THE REPORTED EVENT COULD NOT BE CONFIRMED. THE CAUSE OF THE EVENT CANNOT BE CONCLUSIVELY DETERMINED FROM THE PROVIDED INFORMATION. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED REPORT THAT A PIPELINE FLEX DID NOT OPEN DURING A PROCEDURE. THE PATIENT WAS UNDERGOING TREATMENT OF AN UNRUPTURED, SACCULAR ANEURYSM IN THE "UPPER CAROTID ARTERY." VESSEL TORTUOSITY WAS DESCRIBED AS MODERATE. THE DEVICES WERE PREPARED AS INDICATED IN THE IFU. A CONTINUOUS CATHETER FLUSH WAS MAINTAINED DURING THE PROCEDURE. IT WAS REPORTED THAT DURING THE PROCEDURE, THE CATHETER WAS PLACED, THEN THE PIPELINE FLEX WAS ADVANCED TO THE TREATMENT SITE. THE PIPELINE FLEX WAS REPORTEDLY DEPLOYED, BUT THE DEVICE COULD NOT BE OPENED. REPEATED ATTEMPTS WERE MADE TO OPEN THE DEVICE WITHOUT SUCCESS. THE SYSTEM WAS REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED USING A NEW CATHETER AND PIPELINE FLEX WITHOUT FURTHER ISSUE. THERE WERE NO REPORTS OF PATIENT INJURY IN ASSOCIATION WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    914571 PIPELINE FLEX INTRACRANIAL ANEURYSM FLOW DIVERTER OUT COVIDIEN (IRVINE) PED-450-20 A639618

    Patients

    Seq Age Sex Outcome Treatment
    1