BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PIPELINE FLEX

    MDR report key: 10993231 · Received December 11, 2020

    Report

    Report Number
    2029214-2020-01284
    Event Type
    Malfunction
    Date Received
    December 11, 2020
    Date of Event
    December 8, 2020
    Report Date
    March 8, 2021
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    OUT
    UDI-DI
    00847536016651
    PMA / PMN Number
    P100018.S011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    H3: ANALYSIS OF THE PIPELINE FLEX EMBOLIZATION DEVICE (LOT NO. A861757) FOUND THAT THE BRAID WAS RETURNED ALREADY DETACHED FROM THE PUSHER, AND THE BRAID ENDS (PROXIMAL, DISTAL) COULD NOT BE IDENTIFIED. THE PIPELINE FLEX BRAID ENDS WERE FOUND OPEN BUT DAMAGED (FRAYED). NO BENDS OR KINKS WERE FOUND WITH THE PIPELINE FLEX PUSHER. THE PIPELINE FLEX DISTAL HYPOTUBE DOES NOT APPEAR TO BE STRETCHED AND THE PTFE SHRINK TUBING WAS INTACT. THE PROXIMAL BUMPER, RE-SHEATHING PAD AND RE-SHEATHING MARKER WERE FOUND INTACT. THE PTFE SLEEVES AND TIP COIL WERE FOUND TO BE IN GOOD CONDITION. NO OTHER ANOMALIES WERE OBSERVED. BASED ON THE DEVICE ANALYSIS AND REPORTED INFORMATION, THE CUSTOMER¿S REPORT OF ¿FAILURE/INCOMPLETE OPEN¿ COULD NOT BE CONFIRMED, AS THE DEVICE HAS BEEN FULLY DEPLOYED AND RE-SHEATHED. POSSIBLE CAUSES FOR FAILURE TO OPEN ARE PATIENT VESSEL TORTUOSITY, DAMAGED BRAID, BRAID IMPROPERLY SIZED TO AN ANATOMY, BRAID WAS OVERSTRETCHED DURING DELIVERY, USER DEPLOYS BRAID IN VESSEL BEND, PRESENCE OF OTHER INDWELLING ENDOVASCULAR STENTS, OR INAPPROPRIATE ANATOMY. IN THIS EVENT, IT IS POSSIBLE THE DAMAGE FOUND WITH THE BRAID (FRAYING), THE DEPLOYMENT OF THE BRAID IN A VESSEL BEND, AND THE PATIENT¿S ¿SEVERE¿ VESSEL TORTUOSITY CONTRIBUTED TO THE EVENT. HOWEVER, THE ROOT CAUSE COULD NOT BE DETERMINED. H6: METHOD CODE UPDATED TO B01. RESULT CODE UPDATED TO C070601. CONCLUSION CODE UPDATED TO D1103. 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.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION RECEIVED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE ATTEMPTING TO OPEN THE DEVICE, IT WOULD NOT OPEN CORRECTLY IN THE DISTAL SECTION OF THE PIPELINE. IT WAS STATED IT LOOKED LIKE A TULIP. MORE THAN 50% OF THE PIPELINE HAD BEEN DEPLOYED WHEN IT FAILED. IT WAS RESHEATHED LESS THAN OR EQUAL TO 2 TIMES. THE PIPELINE WAS POSITIONED IN A DISTAL PART OF A BEND. NO ADDITIONAL STEPS OR OTHER DEVICES WERE REQUIRED TO OPEN THE PIPELINE. THE PIPELINE WAS RESHEATHED AND REMOVED WITH THE MICROCATHETER FROM THE PATIENT. ANGIOGRAPHIC RESULT POST PROCEDURE WAS GOOD. THE PATIENT WAS UNDERGOING SURGERY TO TREAT AN UNRUPTURED, SACCULAR ANEURYSM LOCATED AT THE OPTHALMIC ARTERY WITH A MAX DIAMETER OF 5MM AND A NECK DIAMETER OF 4MM. IT WAS NOTED THE VESSEL TORTUOSITY WAS SEVERE. THERE WERE NO PATIENT SYMPTOMS ASSOCIATED WITH THE EVENT. THE DEVICES WERE PREPARED AS INDICATED IN THE IFU.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1457097 PIPELINE FLEX INTRACRANIAL ANEURYSM FLOW DIVERTER OUT MICRO THERAPEUTICS, INC. DBA EV3 PED-475-14 A861757 00847536016651

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR