BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PIPELINE FLEX W/SHIELD TECHNOLOGY

    MDR report key: 10324585 · Received July 26, 2020

    Report

    Report Number
    2029214-2020-00731
    Event Type
    Malfunction
    Date Received
    July 26, 2020
    Date of Event
    July 22, 2020
    Report Date
    September 8, 2020
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    OUT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    H3: THE PIPELINE FLEX W/ SHIELD (MODEL: PED2-450-16 LOT: A862907) (PLI-10) AND PHENOM-027 MICRO CATHETER (MODEL: FG15150-0615-1S LOT: OC19-038) (PLI-20) WERE RETURNED FOR ANALYSIS. THE PHENOM-027 MICRO CATHETER TOTAL LENGTH WAS MEASURED TO BE ~158.9CM, THE USABLE LENGTH WAS MEASURED TO BE ~152.2CM AND THE DISTAL SINGLE COIL LENGTH WAS MEASURED TO BE ~14.6CM, WHICH IS WITHIN SPECIFICATION. THE INNER DIAMETER WAS MEASURED TO BE 0.0265¿ AT THE DISTAL END AND ~0.0270¿ AT THE PROXIMAL END WHICH IS WITHIN SPECIFICATION AND COMPATIBLE FOR USE WITH THE PIPELINE FLEX W/ SHIELD. NO FLASH OR VOIDS MOLDED WERE FOUND WITHIN THE CATHETER HUB. NO DAMAGES OR ANOMALIES WERE FOUND WITH THE HUB, CATHETER BODY, DISTAL TIP OR MARKER BANDS. THE MICRO CATHETER WAS FLUSHED WITH WATER AND WATER EXITED VERY SLOWLY OUT FROM THE CATHETER TIP. RESISTANCE WAS FOUND WHEN ADVANCING THE PIPELINE FLEX W/ SHIELD OUT OF THE MICRO CATHETER. THE CATHETER WAS THEN TESTED BY RUNNING AN IN-HOUSE 0.0260¿ MANDREL THROUGH MICROCATHETER. THE MANDREL PASSED THROUGH THE CATHETER HUB, CATHETER BODY AND DISTAL TIP WITH NO RESISTANCE ENCOUNTERED. NO DAMAGES OR IRREGULARITIES WERE FOUND WITH THE PIPELINE FLEX W/ SHIELD PUSHER. THE DISTAL AND PROXIMAL DPS RESTRAINTS WERE FOUND TO BE 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 OR WITH THE PROXIMAL BUMPER. THE TIP COIL WAS INTACT. ONCE DEPLOYED OUT OF THE MICRO CATHETER, THE DISTAL AND PROXIMAL ENDS OF THE PIPELINE FLEX SHIELD BRAID WERE FOUND FULLY OPENED, WITH THE DISTAL END FOUND DAMAGED/FRAYED AND THE PROXIMAL END INTACT. NO OTHER ANOMALIES WERE OBSERVED. BASED ON THE ANALYSIS FINDINGS, THE PIPELINE FLEX SHIELD AND PHENOM-027 WERE CONFIRMED TO HAVE ¿RESISTANCE STUCK DURING DELIVERY¿ AND ¿CATHETER RESISTANCE¿ AS RESISTANCE WAS FOUND WITH THE RETURNED PIPELINE FLEX SHIELD AND THE PHENOM CATHETER. IT IS POSSIBLE THAT DAMAGE FOUND ON THE BRAID CAUSED THE RESISTANCE FOUND. IT IS ALSO POSSIBLE THAT ADVANCING THE DEVICE AGAINST RESISTANCE, ALONG WITH THE REPORTED HIGH PATIENT VESSEL TORTUOSITY AND REPORTED MULTIPLE RE-SHEATHING ATTEMPTS CAUSED THE BRAID TO BECOME DAMAGED. THE CUSTOMER¿S REPORT OF ¿FAILURE/INCOMPLETE OPEN DISTAL (FLEX)¿ COULD NOT BE CONFIRMED THROUGH ANALYSIS OF THE DEVICE AS THE BRAID FULLY OPENED WHEN DEPLOYED OUT OF THE MICRO CATHETER. POSSIBLE CAUSES FOR FAILURE ARE PATIENT VESSEL TORTUOSITY, DAMAGED BRAID, BRAID IMPROPERLY SIZED TO ANATOMY, BRAID OVERSTRETCHED DURING DELIVER, USER DEPLOYS BRAID IN VESSEL BEND, PRESENCE OF OTHER INDWELLING ENDOVASCULAR STENT AND INAPPROPRIATE ANATOMY. NO OTHER DAMAGES OR NON-CONFORMANCES WERE FOUND THAT WOULD CONTRIBUTE TOWARDS THE FAILURES. 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 THERE WAS RESISTANCE IN THE PHENOM 27, AND THE PIPELINE FAILED TO OPEN DISTALLY. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF AN AMORPHOUS, UNRUPTURED ANEURYSM WITH A MAX DIAMETER OF 7MM AND A 3MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS SEVERE. IT WAS REPORTED THAT THE PATIENT'S INITIAL VASOSPASMS WERE SOLVED WITH THE ADMINISTRATION OF NIMOTOP IA DURING THE DIAGNOSTIC PHASE. WHEN INTRODUCING THE PIPELINE INTO THE PHENOM 27 MICROCATHETER, THERE WAS HUGE FRICTION WHEN PUSHING THE STENT. THEN, WHEN THE PIPELINE WAS DISTALLY PUSHED OUT OF THE MICROCATHETER, THE DISTAL SEGMENT DID NOT OPEN. AFTER MANY ATTEMPTS, THE MICROCATHETER WITH THE PIPELINE WAS REMOVED. IT WAS NOTED THE CATHETER WAS FLUSHED CONTINUOUSLY WITH SALINE, NO DAMAGE WAS NOTED TO THE CATHETER OR PIPELINE, THE DEVICES WERE NOT IN A BEND, MORE THAN 50% OF THE PIPELINE WAS DEPLOYED, AND RE-SHEATHING WAS ATTEMPTED MORE THAN TWICE. 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. AFTER THE TREATMENT WITH ANOTHER PIPELINE, THE ANGIOGRAPHIC RESULTS SHOWED GOOD RESULTS. ANCILLARY DEVICES INCLUDE A ENVOY 6F, SOFIA 5F 115CM, PHENOM 27.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    788722 PIPELINE FLEX W/SHIELD TECHNOLOGY LASER THERAPY PRODUCT OUT MICRO THERAPEUTICS, INC. DBA EV3 PED2-450-16 A862907

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR