BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PIPELINE FLEX W/SHIELD TECHNOLOGY

    MDR report key: 10414608 · Received August 17, 2020

    Report

    Report Number
    2029214-2020-00804
    Event Type
    Malfunction
    Date Received
    August 17, 2020
    Date of Event
    August 13, 2020
    Report Date
    March 5, 2021
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    OUT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    H3: THE PIPELINE FLEX DELIVERY SYSTEM (MODEL: PED2-500-18 LOT: A984413) AND PHENOM-27 CATHETER (MODEL: FG15150-0615-1S LOT: DE19-049) WERE RETURNED FOR ANALYSIS. THE PIPELINE FLEX PUSHWIRE WAS RETURNED OUTSIDE THE PHENOM CATHETER. THE PIPELINE FLEX BRAID WAS STUCK INSIDE THE PHENOM CATHETER PROXIMAL END AND HUB. FOR FURTHER EXAMINATION, CATHETER WAS CUT TO REMOVE PIPELINE FLEX BRAID. 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 APPEARED TO BE SLIGHTLY STRETCHED WITH THE PTFE SHRINK TUBING STILL INTACT. NO BEND WAS OBSERVED ON THE PUSHWIRE. THE DISTAL AND PROXIMAL ENDS OF THE PIPELINE FLEX BRAID WERE FOUND FULLY OPENED AND MODERATELY FRAYED. NO DEFECTS WERE FOUND WITH THE TIP COIL, DISTAL MARKER, RE-SHEATHING MARKER, RE-SHEATHING PAD OR WITH THE PROXIMAL BUMPER. THE TOTAL AND USABLE LENGTHS OF THE CATHETER WERE MEASURED TO BE WITHIN SPECIFICATIONS. THE CATHETER TIP, MARKER AND BODY WERE EXAMINED; AND NO DAMAGES WERE FOUND. NO FLASH OR VOIDS MOLDED WERE OBSERVED IN THE HUB. THE CATHETER WAS FLUSHED WITH WATER AND WATER EXITED OUT FROM THE DISTAL TIP. THE CATHETER WAS THEN TESTED BY RUNNING AN IN-HOUSE 0.0265¿ MANDREL THROUGH CATHETER TIP AND HUB. THE MANDREL SUCCESSFULLY PASSED THROUGH THE CATHETER HUB, LUMEN AND TIP WITH NO ISSUES. NO OTHER ANOMALIES WERE OBSERVED. BASED ON THE ANALYSIS FINDINGS, THE PIPELINE FLEX WAS NOT CONFIRMED TO HAVE FAILURE TO OPEN AT THE DISTAL END AS THE DISTAL AND PROXIMAL ENDS OF THE PIPELINE FLEX BRAID WERE FOUND FULLY OPENED AND DAMAGED. HOWEVER, THE ROOT CAUSE AND THE CAUSE FOR DAMAGE COULD NOT BE DETERMINED. POSSIBLE CONTRIBUTING FACTOR OF FAILURE TO OPEN INCLUDES PATIENT TORTUOUS ANATOMY. IT WAS REPORTED, THE PATIENT'S VESSEL TORTUOSITY WAS MINIMAL. THERE WAS NO NON-CONFORMANCE TO SPECIFICATIONS IDENTIFIED THAT LED TO THE FAILURE TO OPEN ISSUE. 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 PIPELINE FAILED TO OPEN DISTALLY. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM OF THE LEFT INTERNAL CAROTID ARTERY WITH A MAX D IAMETER OF 9MM AND A 4MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MINIMAL. IT WAS REPORTED THAT THE PIPELINE FAILED TO OPEN DISTALLY EVEN THOUGH IT WAS OPENED IN THE MIS SECTION. THE PROXIMAL AND MIDDLE SECTIONS OF THE PIPELINE WERE POSITIONED IN A BEND, AND MORE THAN 50% OF THE PIPELINE WAS DEPLOYED. THE PHYSICIAN RE-SHEATHED THREE TIMES AND ALSO PULLED THE STENT BACK ON THE STRAIGHT SEGMENT. NO ADDITIONAL ACTIONS WERE PERFORMED TO OPEN THE PIPELINE. THE PHYSICIAN REMOVED THE DEVICE, AND A REPLACEMENT PRODUCT WASUSED 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 ANGIOGRAPHIC RESULTS SHOWED GOOD WALL APPOSITION AND THE STENT WAS PATENT. ANCILLARY DEVICES INCLUDE A SOFIA 6F, NEURON MAX 6F, PHENOM MICROCATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    881529 PIPELINE FLEX W/SHIELD TECHNOLOGY INTRACRANIAL ANEURYSM FLOW DIVERTER OUT MICRO THERAPEUTICS, INC. DBA EV3 PED2-500-18 A984413

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR