BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PIPELINE FLEX

    MDR report key: 11343682 · Received February 18, 2021

    Report

    Report Number
    2029214-2021-00184
    Event Type
    Malfunction
    Date Received
    February 18, 2021
    Date of Event
    February 8, 2021
    Report Date
    May 12, 2021
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    OUT
    UDI-DI
    00847536019751
    PMA / PMN Number
    P100018.S011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    H3: ANALYSIS OF THE PIPELINE FLEX (LOT NO. B032587) FOUND THAT THE PUSHWIRE COULD NOT BE PUSHED FORWARD OR REMOVED FROM THE CATHETER. FOR FURTHER EXAMINATION, THE CATHETER WAS CUT TO REMOVE THE PUSHWIRE. THE PUSHWIRE APPEARED TO BE SEPARATED AT THE DISTAL HYPOTUBE. THERE WAS NO DISTAL BROKEN SEGMENT OR PIPELINE FLEX BRAID RETURNED WITH THE PUSHWIRE. THE DISTAL HYPOTUBE WAS FOUND SEVERELY STRETCHED WITH THE PTFE SHRINK TUBING STILL INTACT. NO BEND WAS FOUND WITH THE PUSHWIRE. THE TOTAL AND USABLE LENGTH OF THE CATHETER WERE MEASURED TO BE WITHIN SPECIFICATIONS. THE PHENOM 27 CATHETER TIP AND THE MARKER BAND WERE EXAMINED; AND NO DAMAGES WERE FOUND. THE CATHETER BODY APPEARED TO BE FLATTENED AT 2.0 CM TO 16.0 CM; AND ACCORDIONED FROM 17.5 CM TO 23.0 CM FROM THE DISTAL TIP. NO FLASH OR VOIDS MOLDED WERE OBSERVED IN THE HUB. THE CATHETER WAS THEN TESTED BY RUNNING AN IN-HOUSE 0.0265¿ MANDREL THROUGH HUB. THE MANDREL COULD PASS THROUGH THE CATHETER HUB WITH NO ISSUES; HOWEVER, RESISTANCE WAS OBSERVED AT THE DAMAGED LOCATIONS. NO OTHER ANOMALIES WERE OBSERVED. THE BROKEN END OF THE PUSHWIRE WAS SENT OUT FOR SEM ANALYSIS. BASED ON THE ANALYSIS FINDINGS, THE PIPELINE FLEX AND PHENOM 27 CATHETER WERE CONFIRMED TO HAVE "PUSHWIRE SEPARATION" AND "RESISTANCE DURING DELIVERY" ISSUES AS THE RETURNED PIPELINE FLEX PUSHWIRE WAS FOUND STUCK INSIDE THE PHENOM 27 CATHETER. IN ADDITION, THE PUSHWIRE WAS SEPARATED AT THE DISTAL HYPOTUBE. PER THE SEM RESULTS: THE FRACTURE FEATURES (DIMPLES) OBSERVED INDICATE A BENDING/TWISTING OVERLOAD TYPE FAILURE. ADDITIONALLY, FROM THE DAMAGES SEEN ON THE CATHETER BODY (FLATTENING/ACCORDIONING) AND PUSHWIRE HYPOTUBE (STRETCHING); IT APPEARS THERE WAS HIGH FORCE USED. IT IS LIKELY THESE DAMAGES OCCURRED WHEN THE CUSTOMER ATTEMPTED TO ADVANCE THE PIPELINE FLEX THROUGH THE CATHETER AGAINST THE RESISTANCE. HOWEVER, THE CAUSE FOR RESISTANCE COULD NOT BE DETERMINED. POSSIBLE CAUSES OF RESISTANCE INCLUDE PATIENT TORTUOUS ANATOMY AND LACK OF CONTINUOUS FLUSH WITH HEPARINIZED SALINE DURING DELIVERY. SINCE THE DISTAL SEGMENT OF THE PUSHWIRE AND THE BRAID WERE NOT RETURNED; ANY CONTRIBUTION OF THE DISTAL SEGMENT AND BRAID TO THE RESISTANCE ISSUE COULD NOT BE DETERMINED. PER OUR INSTRUCTIONS FOR USE (IFU), THE USER SHOULD: ¿DISCONTINUE DELIVERY OF THE DEVICE IF HIGH FORCE OR EXCESSIVE FRICTION IS ENCOUNTERED DURING DELIVERY. IDENTIFY THE CAUSE OF THE RESISTANCE AND REMOVE DEVICE AND MICROCATHETER SIMULTANEOUSLY. ADVANCEMENT OF THE PED AGAINST RESISTANCE MAY RESULT IN DEVICE DAMAGE OR PATIENT INJURY. NEVER ADVANCE OR WITHDRAW AN INTRALUMENAL DEVICE AGAINST RESISTANCE UNTIL THE CAUSE OF RESISTANCE IS DETERMINED BY FLUOROSCOPY. IF THE CAUSE CANNOT BE DETERMINED, WITHDRAW THE CATHETER. MOVEMENT OF THE MICRO CATHETER AGAINST RESISTANCE MAY RESULT IN DAMAGE TO THE MICRO CATHETER, OR THE VESSEL. DO NOT USE IN PATIENTS IN WHOM THE ANGIOGRAPHY DEMONSTRATES THE ANATOMY IS NOT APPROPRIATE FOR ENDOVASCULAR TREATMENT, DUE TO CONDITIONS SUCH AS SEVERE INTRACRANIAL VESSEL TORTUOSITY OR STENOSIS.¿ H6: METHOD CODE UPDATED TO B19. RESULT CODE UPDATED TO C0702, C070601, AND C070603. CONCLUSION CODE UPDATED TO D1102. 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 A REPORT THAT THE PIPELINE STENT IMPLANTATION WAS UNSUCCESSFUL TWICE. THE FIRST TIME WAS BECAUSE THE PIPELINE DELIVERY GUIDEWIRE WAS BROKEN. THE SECOND TIME, THE DISTAL WAS ENLARGED DURING THE OPERATION AND THE ANCHORING WAS UNSTABLE. IT WAS FLATTENING AT THE BENT SITE AND REQUIRED REPEATED SWINGING TO RELEASE, BUT THE DISTAL FELL DOWN DURING SWINGING. THE CASE ITSELF WAS RATHER DIFFICULT, SO IT FAILED AGAIN. REPLACEMENT DEVICES WERE USED 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 NORMAL EMBOLISM. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM OF THE RIGHT C4 INTERNAL CAROTID ARTERY (ICA) AND LEFT C5 ICA WITH A MAX DIAMETER OF 15.54 MM AND A 11.63 MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MINIMAL. PIPELINE LOT #: B032587 WAS USED WITH CATHETER LOT #: NV19-035; PIPELINE LOT #: B118889 WAS USED WITH CATHETER LOT #: NV19-048. ADDITIONAL INFORMATION RECEIVED CLARIFIED THE DAMAGE TO THE PUSHWIRE, IT WAS STATED THE WIRE SEPARATED INTO TWO SECTIONS. WHEN THE PIPELINE WAS DELIVERED INTO THE MICROCATHETER, THE RESISTANCE WAS TOO LARGE WHICH BROKE THE PUSHWIRE. IT WAS CLARIFIED WITH THE SECOND PIPELINE THAT DUE TO THE POOR OPENING OF THE MIDDLE SECTION OF THE STENT IN THE BLOOD VESSEL, IT WAS REPEATEDLY RECOVERED AND RELEASED. THIS RESULTED IN DAMAGE TO THE PIPELINE TIP AND IT WAS UNABLE TO OPEN AT THE HEAD END. THERE WAS NO RESISTANCE ENCOUNTERED WITH THE SECOND PIPELINE. DUAL ANTIPLATELET THERAPY (DAPT) WAS ADMINISTERED, AND THE PLATELET REACTIVITY UNITS (PRU) LEVEL WAS NOT RECORDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    240304 PIPELINE FLEX INTRACRANIAL ANEURYSM FLOW DIVERTER OUT MICRO THERAPEUTICS, INC. DBA EV3 PED-500-25 B032587 00847536019751

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR