BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PIPELINE FLEX W/SHIELD TECHNOLOGY

    MDR report key: 8218884 · Received January 4, 2019

    Report

    Report Number
    2029214-2019-00008
    Event Type
    Malfunction
    Date Received
    January 4, 2019
    Date of Event
    December 11, 2018
    Report Date
    June 24, 2019
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    OUT
    PMA / PMN Number
    P100018.S011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MY
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    IMAGES RELEVANT TO THE COMPLAINT WERE NOT AVAILABLE FOR REVIEW. THE PIPELINE FLEX (WITH SHIELD) EMBOLIZATION DEVICE (MODEL: PED2-450-25 LOT: A518688) WAS RETURNED FOR ANALYSIS WITHIN A SHIPPING BOX; WITHIN AN OPENED PIPELINE FLEX OUTER CARTON; WITHIN AN OPENED PIPELINE FLEX INNER POUCH AND WITHOUT ITS DISPENSER COIL. THE PIPELINE FLEX BRAID WAS RETURNED ALREADY DEPLOYED FROM THE PUSHWIRE. NO BENDS OR KINKS WERE FOUND WITH THE PIPELINE FLEX PUSHWIRE. THE DISTAL HYPOTUBE AND PTFE SHRINK TUBING WERE FOUND TO BE INTACT WITH NO SIGNS OF ELONGATION. NO DAMAGES WERE FOUND PROXIMAL BUMPER, RE-SHEATHING PAD, DISTAL MARKER, PTFE SLEEVES OR COIL TIP. THE PIPELINE FLEX BRAID WAS FOUND OPEN AND IN GOOD CONDITION WITH MODERATE FRAYING ON ONE END. NO OTHER ANOMALIES WERE OBSERVED. BASED ON THE DEVICE ANALYSIS AND REPORTED INFORMATION, THE CUSTOMER¿S REPORT OF ¿FAILURE/INCOMPLETE OPEN DISTAL¿ COULD NOT BE CONFIRMED. IT IS LIKELY THE PATIENT¿S ¿SEVERE¿ VESSEL TORTUOSITY CONTRIBUTED TO THE EVENT. REGARDING DAMAGE TO THE BRAID END IS LIKELY THE RESULTS OF THE PHYSICIAN RE-SHEATHING THE DEVICE MORE THAN RECOMMENDED TWO TIMES. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. 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 AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE 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 REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM 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

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

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION THAT THIS PIPELINE FLEX WITH SHIELD TECHNOLOGY DEVICE DID NOT OPEN DURING THE PROCEDURE. THE PATIENT UNDERWENT EMBOLIZATION TREATMENT FOR A MEDIUM UNRUPTURED SACCULAR ANEURYSM LOCATED IN INTERNAL CAROTID ARTERY, MEASURING 16.8MMX8.5MM, DISTAL LANDING ZONE 3.3MM AND PROXIMAL 4.3MM. THE VESSEL WAS OBSERVED SEVERELY TORTUOUS. IT WAS REPORTED THAT THE FIRST PIPELINE DEVICE UNABLE TO OPEN DISTALLY, WAITED ABOUT 2-3MINS AFTER UNSHEATHING ABOUT 10MM BUT THE PIPELINE STILL NOT OPEN. THE PHYSICIAN DECIDED TO RESHEATH THE DEVICE AND RE-DEPLOY. UNSHEALTH AND PUSH THE DELIVERY WIRE BUT THE DISTAL PART STILL NOT OPEN. RESHEATH AND REDEPLOY FOR 2ND TIMES BUT THE PROBLEM REMAINED. PHYSICIAN DECIDED TO REMOVE THE DEVICE AND CHANGE TO THE NEW DEVICE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO REPORTS OF PATIENT INJURY IN ASSOCIATION WITH THIS EVENT. THERE WERE NOT ANY PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT. THE PIPELINE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE IFU. LESS THAN 50% THE PIPELINE HAD BEEN DEPLOYED WHEN IT FAILED TO OPEN. COOK SHUTTLE 6FR 80CM, NAVIEN RFX05811508 A580005, MARKSMAN 027 FA-55150-103 LOT A678089, ECHELON 10 105-5091-150 LOT A396721, AVIGO 103-0606-200 A667041, AXIUM QC-12-40-3D A230772 , AXIUM QC-16-40-3D A223247.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    10674 PIPELINE FLEX W/SHIELD TECHNOLOGY INTRACRANIAL ANEURYSM FLOW DIVERTER OUT MICRO THERAPEUTICS, INC. DBA EV3 PED2-450-25 A518688

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR