BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PIPELINE FLEX W/SHIELD TECHNOLOGY

    MDR report key: 10824372 · Received November 11, 2020

    Report

    Report Number
    2029214-2020-01119
    Event Type
    Malfunction
    Date Received
    November 11, 2020
    Date of Event
    November 4, 2020
    Report Date
    May 3, 2021
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    OUT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H3: ANALYSIS OF THE PIPELINE FLEX EMBOLIZATION DEVICE (LOT NO. A915540) FOUND THAT THE PIPELINE FLEX BRAID AND DISTAL CORE WIRE WERE PARTIALLY DEPLOYED FROM WITHIN THE MARKSMAN DISTAL TIP. THE PIPELINE FLEX PUSHER PTFE SLEEVES WERE FOUND TO BE IN GOOD CONDITION. THE PIPELINE FLEX PUSHER TIP COIL WAS FOUND BENT. THE PIPELINE FLEX EMBOLIZATION DEVICE WAS PUSHED OUT FROM WITHIN THE MARKSMAN CATHETER, DEPLOYING THE BRAID, WITHOUT ISSUE. NO BENDS, KINKS, OR SEPARATIONS WERE FOUND WITH THE PIPELINE FLEX PUSHER. THE PIPELINE FLEX BRAID PROXIMAL END WAS FOUND OPEN AND IN GOOD CONDITION. THE PIPELINE FLEX BRAID DISTAL END WAS FOUND OPEN, BUT DAMAGED (FRAYED). DRIED BLOOD WAS NOTED ON THE PIPELINE FLEX BRAID DISTAL END. NO OTHER ANOMALIES WERE OBSERVED. BASED ON THE DEVICE ANALYSIS AND REPORTED INFORMATION, THE CUSTOMER¿S REPORT OF ¿FAILURE/INCOMPLETE OPEN¿ AND ¿RESISTANCE/STUCK DURING DELIVERY¿ COULD NOT BE CONFIRMED. 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) CONTRIBUTED TO THE EVENT. BRAID DAMAGE CAN OCCUR IF THE DEVICE IS ADVANCED AGAINST RESISTANCE. RESISTANCE CAN OCCUR DURING TRACKING, DEPLOYMENT AND RE-SHEATHING OF THE DEVICE IN DISTAL AND TORTUOUS ANATOMIES. H6: METHOD CODE UPDATED TO B01. RESULT CODE UPDATED TO C070601. CONCLUSION CODE UPDATED TO D15. 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 A REPORT THAT THE DOCTOR FELT RESISTANCE WHEN RISING THE PIPELINE SYSTEM IN THE MARKSMAN MICROCATHETER. WHEN THE RELEASE STARTED, THE STENT DID NOT OPEN IN THE DISTAL PORTION. SEVERAL MANEUVERS WERE PERFORMED WITHOUT SUCCESS. IT WAS NOTED THE PROXIMAL PORTION OF THE STENT WAS POSITIONED IN A BEND, THE PUSHWIRE WAS ROTATED SEVERAL TIMES, LESS THAN 50% OF THE STENT HAD BEEN DEPLOYED, RE-SHEATHING WAS DONE MORE THAN TWICE, AND NO ADDITIONAL STEPS WERE TAKEN IN AN ATTEMPT TO OPEN THE PIPELINE. THE STENT AND MICROCATHETER WERE REMOVED, AND REPLACEMENT PRODUCTS WERE USED TO COMPLETE THE PROCEDURE. IT WAS INDICATED THAT ALL DEVICES WERE PREPARED AS PER THE INSTRUCTIONS FOR USE (IFU), AND NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. POST-PROCEDURE ANGIOGRAPHY SHOWED THE SECOND STENT USED HAD PERFECT RESULTS. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM OF THE INTERNAL CAROTID ARTERY WITH A MAX DIAMETER OF 4.6 MM AND A 4.6 MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS NORMAL. DUAL ANTIPLATELET THERAPY (DAPT) WAS ADMINISTERED, AND THE PLATELET REACTIVITY UNITS (PRU) LEVEL WAS NORMAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1288866 PIPELINE FLEX W/SHIELD TECHNOLOGY INTRACRANIAL ANEURYSM FLOW DIVERTER OUT MICRO THERAPEUTICS, INC. DBA EV3 PED2-475-20 A915540

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR