BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PIPELINE FLEX W/SHIELD TECHNOLOGY

    MDR report key: 11252130 · Received January 29, 2021

    Report

    Report Number
    2029214-2021-00116
    Event Type
    Malfunction
    Date Received
    January 29, 2021
    Date of Event
    January 27, 2021
    Report Date
    March 26, 2021
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    OUT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    H3: ANALYSIS OF THE PIPELINE FLEX W/ SHIELD (MODEL: PED2-500-35 LOT: B060774) AND PHENOM-27 CATHETER (MODEL: FG15150-0615-1S LOT: MA20-008) FOUND THAT THE DISTAL AND PROXIMAL DPS RESTRAINTS WERE INTACT. THE DPS SLEEVES WERE FOUND INTACT WITH NO SIGNS OF DAMAGE. THE HYPOTUBE WAS INTACT AND UNSTRETCHED AND PTFE SHRINK TUBING WAS STILL INTACT. NO DAMAGES WERE FOUND WITH THE DISTAL MARKER, RE-SHEATHING MARKER, RE-SHEATHING PAD OR WITH THE PROXIMAL BUMPER. THE TIP COIL WAS FOUND STRETCHED. THE DEPLOYED BRAID WAS FOUND FULLY OPENED THROUGHOUT THE BRAID. THE TWO ENDS WERE FOUND FRAYED AND DAMAGED. THE MIDDLE BRAID WAS FOUND DAMAGED. THE PHENOM-27 CATHETER TOTAL LENGTH WAS MEASURED TO BE 158.8 CM, THE USABLE LENGTH WAS MEASURED TO BE 152.2 CM AND DISTAL SINGLE COIL LENGTH WAS MEASURED TO BE 14.4 CM, WHICH IS WITHIN SPECIFICATION. NO DAMAGES OR IRREGULARITIES WERE FOUND WITH THE PHENOM-27 CATHETER HUB, BODY, DISTAL TIP AND MARKER BAND. NO OTHER ANOMALIES WERE OBSERVED. BASED ON THE ANALYSIS FINDINGS, THE CUSTOMER¿S REPORT OF ¿FAILURE/INCOMPLETE TO OPEN AT MIDDLE SECTION (HOURGLASS SHAPE)¿ COULD NOT BE CONFIRMED THROUGH DEVICE ANALYSIS AS THE DEVICE WAS RETURNED FULLY OPENED. POSSIBLE CAUSES FOR FAILURE ARE PATIENT VESSEL TORTUOSITY, DAMAGED BRAID, BRAID IMPROPERLY SIZED TO ANATOMY, BRAID OVERSTRETCHED DURING DELIVERY, USER DEPLOYS BRAID IN VESSEL BEND, PRESENCE OF OTHER INDWELLING ENDOVASCULAR STENT AND INAPPROPRIATE ANATOMY. CUSTOMER REPORTED VESSEL TORTUOSITY AS MODERATE, DEVICES WERE PREPARED AS PER IFU AND DEVICE WAS PLACED IN A VESSEL BEND. THE BRAID WAS FOUND DAMAGED. POSSIBLE CAUSES ARE RE-SHEATHING MORE THAN 2 TIMES, HIGH FORCE DELIVERY, OVER-MANIPULATION AND DELIVERING/RETRACTING WIRE AGAINST RESISTANCE. CUSTOMER REPORTED DEVICE WAS RESHEATHED MORE THAN 3 TIMES AND NO RESISTANCE WAS ENCOUNTERED. AS THE BRAID WAS RETURNED ALREADY DEPLOYED OUTSIDE OF ITS PROTECTIVE DISPENSER COIL AND INTRODUCER SHEATH, IT IS ALSO POSSIBLE DAMAGES OCCURRED DURING RETURN SHIPPING TO MEDTRONIC. NO DAMAGES OR IRREGULARITIES WERE FOUND WITH THE RETURNED PHENOM-27 CATHETER THAT WOULD CONTRIBUTE TOWARDS THE REPORTED FAILURE. 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

    MEDTRONIC RECEIVED INFORMATION REGARDING A PIPELINE THAT FAILED TO OPEN AND WAS TWISTED IN THE MIDDLE SECTION. THE PATIENT WAS UNDERGOING A PROCEDURE TO IMPLANTATION OF A FLOW DIVERSION STENT TO TREAT AN UNRUPTURED SACCULAR ANEURYSM OF THE RIGHT INTERNAL CAROTID ARTERY (R-ICA) POSTERIOR COMMUNICATING SEGMENT. THE ANEURYSM MAX DIAMETER WAS 12MM AND THE NECK DIAMETER WAS 8MM. THE DISTAL LANDING ZONE DIAMETER WAS 4.7MM AND THE PROXIMAL LANDING ZONE DIAMETER WAS 5.00MM. VESSEL TORTUOSITY WAS MODERATE. IT WAS REPORTED THAT ALL DEVICES WERE PREPARED AND THE CATHETER FLUSHED ACCORDING TO INSTRUCTIONS FOR USE (IFU). THE GUIDE CATHETER AND INTRACRANIAL SUPPORT CATHETER WERE IN PLACE. THE MICROCATHETER WAS DELIVERED TO THE M1 BY THE GUIDEWIRE. THE PIPELINE WAS THEN ADVANCED TO THE DISTAL TIP OF THE MICROCATHETER. AT THE MIDDLE CEREBRAL ARTERY (MCA), THE SLEEVE WAS REMOVED AT THE TIP OF THE MICROCATHETER PIPELINE DEPLOYMENT BACK. THE PHYSICIAN WAS ATTEMPTING TO PLACE THE PIPELINE IN A VESSEL BEND. THE DISTAL TIP OF THE PIPELINE OPENED WELL BUT A TWIST OCCURRED IN THE MIDDLE OF THE PIPELINE IN THE VESSEL BEND AROUND THE IC-PARACLI. THE PIPELINE WAS RESHEATHED AND MASSAGED ABOUT 30 TIMES BUT REMAINED TWISTED. THE DEVICE WAS FULLY RESHEATHED AND THE SYSTEM REPOSITIONED SLIGHTLY AND REDEPLOYMENT ATTEMPTED. HOWEVER, THE SAME PART OF THE PIPELINE REMAINED TWISTED. MULTIPLE ATTEMPTS AND TECHNIQUES WERE MADE TO TRY AND OPEN THE PIPELINE - RESHEATHING 3 OR MORE TIMES, ADJUSTING POSITION, PUSHED WITH A WIRE, PUSHED AND PULLED THE SYSTEM, ATTEMPTED DEPLOYMENT IN THE GUIDE CATHETER, VIBRATION AND MASSAGE OF THE STENT - BUT NOTHING WORKED TO OPEN THE PIPELINE AND REMOVE THE TWIST. FINALLY THE PIPELINE WAS RESHEATHED AND REMOVED WITH THE MICROCATHETER. IT WAS NOTED THAT NO RESISTANCE WAS FELT DURING DELIVERY OR RETRIEVAL OF THE PIPELINE. AFTER RETRIEVAL OUTSIDE THE PATIENT'S BODY, THE PIPELINE WAS CHECK AND FOUND TO HAVE A THROMBUS-LIKE MASS ATTACHED TO IT WHICH HINDERED THE STENT FROM OPENING. SINCE THE SYSTEM OF REMOVED, NO THROMBUS MATERIAL REMAINED IN THE PATIENT. THE PIPELINE AND MICROCATHETER WERE BOTH REPLACED WITH NEW DEVICES OF THE SAME MODELS AND THE REPLACEMENT PIPELINE WASSAFELY IMPLANTED WITHOUT ISSUE TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WAS NO INJURY TO THE PATIENT. POST-OPERATIVE ANGIOGRAPHY SHOWED A CLEAR ECLIPSE SIGN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    151652 PIPELINE FLEX W/SHIELD TECHNOLOGY INTRACRANIAL ANEURYSM FLOW DIVERTER OUT MICRO THERAPEUTICS, INC. DBA EV3 PED2-500-35 B060774

    Patients

    Seq Age Sex Outcome Treatment
    1