BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PIPELINE FLEX W/SHIELD TECHNOLOGY

    MDR report key: 11723935 · Received April 26, 2021

    Report

    Report Number
    2029214-2021-00481
    Event Type
    Malfunction
    Date Received
    April 26, 2021
    Date of Event
    April 1, 2021
    Report Date
    July 26, 2021
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    OUT
    UDI-DI
    00763000284701
    PMA / PMN Number
    P100018.S026
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    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 · 0

    G3: PMA/510(K) CORRECTED. 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 · 0

    H3: ANALYSIS OF THE PIPELINE EMBOLIZATION DEVICE (LOT NO. B043147) FOUND THAT THE PIPELINE PUSHWIRE WAS NOT RETURNED. THE PROXIMAL BUMPER, RE-SHEATHING MARKER AND RE-SHEATHING PAD WERE FOUND TO BE MISSING AND NOT RETURNED. THE PROXIMAL BRAID END WAS FOUND TO BE OPENED AND FRAYED. THE DISTAL BRAID END WAS FOUND TO BE OPENED AND FRAYED. NO OTHER DAMAGES OR ANOMALIES WERE FOUND WITH THE DEVICE. BASED ON THE DEVICE ANALYSIS AND REPORTED INFORMATION, THE CUSTOMER¿S REPORT OF ¿FAILURE/INCOMPLETE OPEN DISTAL¿ WAS UNABLE TO BE CONFIRMED AS EACH BRAID END OF THE PIPELINE FLEX BRAID WERE FOUND TO BE FULLY OPEN. POSSIBLE FACTORS FOR FAILURE TO OPEN IS THE RESULT OF VESSEL TORTUOSITY OR RE-SHEATHING THE DEVICE MORE THAN THE RECOMMENDED TWO TIMES. BASED ON THE DEVICE ANALYSIS AND REPORTED INFORMATION, THE CUSTOMER¿S REPORT OF ¿CATHETER KICK BACK¿ WAS UNABLE TO BE CONFIRMED AND THE ROOT CAUSE COULD NOT BE DETERMINED. H6: METHOD CODE UPDATED TO B19. 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.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT PATIENT WAS TREATED FOR A "LARGE" ANEURYSM. VESSEL TORTUOSITY WAS MODERATE. THE WAS NO FRICTION OR OTHER DIFFICULTY DURING THE DELIVERY OF THE SECOND PIPELINE; THE CATHETER WAS MOVED BEFORE THE PIPELINE WAS FULLY ADVANCED. THE TIP OF THE CATHETER WAS NOT UNDER STRESS AND THE PIPELINE DID NOT JUMP DURING DEPLOYMENT.

    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 REGARDING A PIPELINE THAT HAD DIFFICULT NAVIGATION TO THE INTENDED LOCATION AND THEN FAILED TO OPEN AND BECAME LOCKED UP AT THE DISTAL END OF THE CATHETER. A SECOND PIPELINE COULD NOT BE DELIVERED BECAUSE THE CATHETER MOVED OUT OF PLACE. IT WAS REPORTED THAT THE PATIENT WAS UNDERGOING A PROCEDURE FOR FLOW DIVERSION TREATMENT OF AN ANEURYSM. THE PIPELINES AND ALL ACCESSORY DEVICES WERE PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THERE WAS DIFFICULTY NAVIGATING THE PHENOM-27 MICROCATHETER THROUGH THE LARGE ANEURYSM TO THE INTENDED LOCATION BUT THIS WAS EVENTUALLY SUCCESSFUL WHEN A SOLITAIRE WAS PLACED WITHIN THE PHENOM MICROCATHETER TO TAKE OUT THE SLACK. A PIPELINE WITH SHIELD (MODEL PED2-500-16, LOT: B043147) WAS ADVANCED THROUGH THE CATHETER BUT WOULD NOT OPEN AT THE DISTAL END WHEN DELIVERED. MORE THAN 50% OF THE PIPELINE WAS DEPLOYED WHEN THE FAILURE TO OPEN OCCURRED. THE PIPELINE WAS NOT POSITIONED IN A VESSEL BEND. THE DEVICE WAS RESHEATHED MORE THAN 2 TIMES; NO OTHER DEVICES OR STEPS WERE TRIED TO OPEN HELP OPEN THE PIPELINE. FINALLY THE PIPELINE WAS RESHEATHED AND REMOVED WITH THE MICROCATHETER. A SECOND PIPELINE (MODEL: PED-475-20, LOT: A887937) WAS OPENED TO BE USED BUT ON ADVANCING THE PIPELINE, THE CATHETER SLIPPED OUT OF POSITION AND ACCESS COULD NOT BE REGAINED THROUGH THE ANEURYSM. THE PHYSICIAN DECIDED TO STOP THE PROCEDURE BECAUSE OF LONG EXPOSURE FOR THE PATIENT. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    624409 PIPELINE FLEX W/SHIELD TECHNOLOGY INTRACRANIAL ANEURYSM FLOW DIVERTER OUT MICRO THERAPEUTICS, INC. DBA EV3 PED2-500-16 B043147 00763000284701

    Patients

    Seq Age Sex Outcome Treatment
    1