BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PIPELINE FLEX W/SHIELD TECHNOLOGY

    MDR report key: 11825725 · Received May 14, 2021

    Report

    Report Number
    2029214-2021-00574
    Event Type
    Malfunction
    Date Received
    May 14, 2021
    Date of Event
    May 11, 2021
    Report Date
    December 8, 2021
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    OUT
    PMA / PMN Number
    P100018
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    G4: PMA # P100018.S026 WAS OMITTED FROM PREVIOUS REPORT IN ERROR. 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

    PRODUCT ANALYSIS: AS FOUND CONDITION: THE PIPELINE FLEX W/ SHIELD DEVICE AND MARKSMAN MICRO CATHETER WERE RETURNED FOR ANALYSIS WITHIN SHIPPING BOX; WITHIN A SEALED TYVEK BIOHAZARD POUCH; WITHIN A SEALED PLASTIC BIOHAZARD POUCH; WITHIN AN OPENED PIPELINE FLEX W/ SHIELD OUTER CARTON AND WITHIN AN OPENED PIPELINE FLEX W/ SHIELD INNER POUCH. THE ALREADY DEPLOYED BRAID WAS ALSO RETURNED WITHIN THE SAME INNER POUCH. VISUAL INSPECTION/DAMAGE LOCATION DETAILS: NO DAMAGES OR IRREGULARITIES WERE FOUND WITH THE MARKSMAN CATHETER HUB. THE PIPELINE FLEX W/ SHIELD PUSHER WAS FOUND EXTENDING OUT OF THE HUB ~46.7CM. THE MARKSMAN MICRO CATHETER WAS FOUND ACCORDIONED BETWEEN ~27.2CM AND ~22.5CM, AND BETWEEN ~8.5CM AND ~4.1CM FROM THE DISTAL END. THE MICRO CATHETER WAS ALSO FOUND KINKED AT ~0.6CM FROM THE DISTAL END. THE DISTAL TIP AND MARKER BAND WERE FOUND SLIGHTLY CRUSHED. THE PUSHER COULD NOT BE RETRACTED BACK WITHIN THE MICRO CATHETER AS IT WAS FOUND STUCK AT THE DISTAL END AND WAS ADVANCED OUT AGAINST RESISTANCE. NO DAMAGES OR IRREGULARITIES WERE FOUND WITH THE PROXIMAL PUSHER. THE HYPOTUBE WAS FOUND UNSTRETCHED AND UNDAMAGED WITH THE PTFE SHRINK TUBING STILL INTACT. NO DAMAGES WERE FOUND WITH THE DISTAL MARKER, RE-SHEATHING MARKER, RESHEATHING PAD OR WITH THE PROXIMAL BUMPER. THE DISTAL AND PROXIMAL DPS RESTRAINTS WERE FOUND TO BE INTACT. THE DPS SLEEVES WERE FOUND INTACT WITH NO SIGNS OF DAMAGE. THE TIP COIL WAS FOUND DAMAGED. ONE BRAID END WAS FOUND FULLY OPENED, FRAYED AND DAMAGED. THE MIDDLE BRAID WAS FOUND FLATTENED. THE OTHER BRAID END WAS FOUND FULLY OPENED, FRAYED, DAMAGED AND FLATTENED. TESTING/ANALYSIS: THE MARKSMAN MICRO CATHETER TOTAL LENGTH WAS MEASURED TO BE ~157.0CM AND THE USABLE LENGTH WAS MEASURED TO BE ~149.4CM, WHICH IS WITHIN SPECIFICATION (SPECIFICATION: TOTAL (REF) = 157CM ± 3CM, USABLE = 150CM ± 3CM). THE INNER DIAMETER OF THE MICRO CATHETER WAS MEASURED TO BE 0.0270¿ AT BOTH ENDS WHICH IS WITHIN SPECIFICATION (SPECIFICATION: 0.027¿ ± 0.001¿). CONCLUSION: BASED ON THE ANALYSIS FINDINGS, THE CUSTOMER REPORT OF ¿FAILURE/INCOMPLETE OPEN DISTAL (FLEX)¿ COULD NOT BE CONFIRMED THROUGH DEVICE ANALYSIS AS THE DEVICE WAS RETURNED FULLY OPENED. POSSIBLE CAUSES FOR FAILURE TO OPEN ARE PATIENT VESSEL TORTUOSITY, DAMAGED BRAID, BRAID IMPROPERLY SIZED TO ANATOMY, BRAID WAS OVERSTRETCHED DURING DELIVERY, USER DEPLOYS BRAID IN VESSEL BRAID, PRESENCE OF OTHER INDWELLING STENTS OR INAPPROPRIATE ANATOMY. THE BRAID WAS FOUND DAMAGED. POTENTIAL CAUSES FOR BRAID DAMAGE ARE RESHEATHING MORE THAN 2 TIMES, HIGH FORCE DELIVERY, OVER-MANIPULATION, DELIVERING/RETRACTING DELIVERY WIRE AGAINST RESISTANCE, DEPLOYING/RESHEATHING BRAID AGAINST RESISTANCE, OR DAMAGE DURING RETURN SHIPPING AS THE BRAIDS WERE RETURNED ALREADY DEPLOYED AND OUT OF ITS PROTECTIVE INTRODUCER SHEATH AND DISPENSER COIL. CUSTOMER REPORTED PIPELINE WAS POSITIONED IN A BEND, DEVICE WAS RESHEATHED 2 OR LESS TIMES, ALL DEVICES WERE PREPARED PER IFU, AND PATIENT VESSEL TORTUOSITY AS MODERATE. THE CUSTOMER REPORT OF ¿CATHETER STRETCHING¿ WAS NOT CONFIRMED, HOWEVER, THE CATHETER WAS FOUND ACCORDIONED. IT IS LIKELY THE ACCORDIONING OCCURRED DUE TO ATTEMPTS TO RETRACT THE PUSHER AGAINST THE FOUND RESISTANCE. THE CUSTOMER REPORT OF ¿MOVEMENT DURING DEPLOYMENT¿ COULD NOT BE CONFIRMED THROUGH DEVICE ANALYSIS. POSSIBLE CAUSES ARE VASOSPASM, PATIENT VESSEL TORTUOSITY, HIGH FORCE DELIVERY, CATHETER KICKBACK, INSUFFICIENT DISTAL ANCHORING OF BRAID, OR INCORRECT BRAID SIZING. THERE IS NO INDICATION THAT THE EVENT IS RELATED TO A POTENTIAL MANUFACTURING 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 · 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.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT WHEN THE MARKSMAN WAS REMOVED ALONG WITH THE PIPELINE, THE MICROCATHETER WAS SEEN TO BE STRETCHED AT ITS DISTAL END.

    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 THERE WAS MOVEMENT/DIFFICULTY DURING DELIVERY OF THE PIPELINE AND IT FAILED TO OPEN DISTALLY. THE PATIENT WAS UNDERGOING TREATMENT FOR AN UNRUPTURED, SACCULAR ANEURYSM LOCATED IN THE LEFT PARAOPHTHALMIC ARTERY. THE MAX DIAMETER WAS 6.3MM, AND THE NECK DIAMETER WAS 5MM. THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. THE LANDING ZONE WAS 4MM DISTAL AND 4.3MM PROXIMAL. THE ACCESS VESSEL WAS THE LEFT INTERNAL CAROTID, WHICH WAS GREATER THAN 6MM IN DIAMETER. DUAL ANTIPLATELET TREATMENT WAS ADMINISTERED. PATIENT MEDICAL HISTORY INCLUDED ARTERIAL HYPERTENSION. IT WAS REPORTED THAT DURING THE APPOSITIONING OF THE DEVICE, THE PIPELINE DID NOT OPEN DISTALLY AND WHEN IT WAS RELEASED MORE IT TWI STED. THE DOCTOR TRIED SEVERAL TIMES TO REPOSITION IT WITHOUT BEING POSSIBLE, SO THEY DECIDED TO REMOVE IT WITH THE MICROCATHETER THE MIDDLE PART OF THE PIPELINE HAD BEEN POSITIONED IN A BEND, AND MORE THAN 50% HAD BEEN DEPLOYED WHEN IT FAILED TO OPEN. THE PHYSICIAN HAD RESHEATHED THE PIPELINE 2 OR LESS TIMES, AND NO OTHER STEPS WERE TAKEN TO OPEN THE DEVICE. THERE HAD BEEN MOVEMENT DURING PLA CEMENT. ONLY THE SINGLE PIPELINE WAS BEING USED WHEN THE MOVEMENT OCCURRED. THE PIPELINE MISSED THE LANDING ZONE. THE DEVICE DID NOT JUMP DURING DEPLOYMENT, AND THE PIPELINE HAD BEEN PLACED AT LEAST 3MM PAST THE ANEURYSM NECK ON EACH SIDE. NO SIDE BRANCHES WERE COVERED BY THE PIPELINE. THE TIP OF THE CATHETER DID NOT MOVE DURING DEPLOYMENT. THERE HAD BEEN MINIMAL FRICTION/DIFFICULTY DURING DELIVERY OR POSITIONING. THE PIPELINE AND CATHETER WERE REMOVED FROM THE PATIENT AND REPLACED. THE EVENT DID NOT LEAD TO AN EXTENDED HOSPITALIZATION. ANGIOGRAPHIC RESULTS POST PROCEDURE WERE SATISFACTORY, UNCOMPLICATED, AND SHOWED ADEQUATE REDIRECTING EFFECT. THE PATIENT DID NOT EXPERIENCE ANY INJURY OR COMPLICATIONS. THE DEVICES WERE PREPARED AND FLUSHED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). ANCILLARY DEVICES INCLUDE A MARKSMAN MICROCATHETER, BOSTON 8FR SHEATH, CHAPERON 6FR GUIDE CATHETER, AND TRAXCESS GUIDEWIRE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    724199 PIPELINE FLEX W/SHIELD TECHNOLOGY INTRACRANIAL ANEURYSM FLOW DIVERTER OUT MICRO THERAPEUTICS, INC. DBA EV3 PED2-450-20 B092244

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Female