BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AXIUM PRIME BRPL 3D

    MDR report key: 11625577 · Received April 6, 2021

    Report

    Report Number
    2029214-2021-00400
    Event Type
    Malfunction
    Date Received
    April 6, 2021
    Date of Event
    March 29, 2021
    Report Date
    June 30, 2021
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    KRD
    UDI-DI
    00847536031906
    PMA / PMN Number
    K151447
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    H3: ANALYSIS OF THE AXIUM COIL (LOT NO. B112955) FOUND THAT THE IMPLANT COIL WAS DETACHED FROM THE PUSHWIRE. THE SHIELD COIL WAS FOUND INTACT BUT STRETCHED. THE COIN WAS NOT PRESENT AGAINST THE LUMEN STOP AS IT WAS PULLING BACK. THE PUSHWIRE WAS FOUND TO BE BROKEN AT THE BREAK INDICATOR. WITH THE RELEASE WIRE PULLING BACK. THE PUSHWIRE WAS FOUND TO BE BENT AT 25.0 CM TO 39.0 CM FROM THE PROXIMAL END. THE AI AND COUPLER TUBING WERE PRESENT AND INTACT. UNDER THE MICROSCOPE, THE OUTER JACKET WAS THEN REMOVED TO GAIN ACCESS THE COIN. THE COIN WAS MEASURED IN 3 LOCATIONS (0.076 MM @ 0.063 MM; MEASURED 0.083 MM @ 0.127 MM. MEASURED 0.097 MM @ 0.275 MM) AND FOUND TO BE WITHIN SPECIFICATIONS. THE INNER DIAMETER OF THE LUMEN STOP AND THE INNER DIAMETER OF THE RETAINER RING WERE FOUND TO BE VISUALLY ACCEPTABLE. THE LUMEN STOP INNER DIAMETER (ID) WAS MEASURED TO BE 0.00270¿ AND FOUND TO BE WITHIN SPECIFICATION. THE RETAINER RING INNER DIAMETER (ID) WAS MEASURED TO BE 0.00463¿AND FOUND TO BE WITHIN SPECIFICATION. THE SL-10 CATHETER APPEARED TO BE CO MPATIBLE FOR USE WITH THE AXIUM PRIME COIL AS IT HAS A LABELED INNER DIAMETER (ID) OF 0.0165". ALL OTHER SUBASSEMBLIES APPEARED TO BE NORMAL. NO OTHER ANOMALIES WERE OBSERVED. BASED ON THE ANALYSIS PERFORMED, THE AXIUM PRIME COIL WAS CONFIRMED TO HAVE "PREMATURE D ETACHMENT" ISSUE AS THE PUSHWIRE WAS RETURNED WITH THE IMPLANT COIL ALREADY DETACHED. BASED ON THE RETURNED DEVICE, THERE WAS EVIDENCE OF MANUAL DETACHMENT ATTEMPT TO DETACH THE COIL AS THE PUSHER WAS FOUND TO BE BROKEN AT THE MANUAL DETACHMENT LOCATION AND RETAINED BY THE RELEASE WIRE; WITH THE COIN PULLED BACK FROM THE LUMEN STOP. THE PULLING BACK OF THE COIN FROM THE LUMEN STOP MAY HAVE CONTRIBUTED TO THE DETACHMENT OF THE IMPLANT COIL FROM THE PUSHWIRE. THERE WAS NO NON-CONFORMANCE TO SPECIFICATION IDENTIFIED THAT THAT LED TO THE NON-DETACHMENT ISSUE. H6: METHOD CODE UPDATED TO B01. RESULT CODE UPDATED TO C070601 AND C070603. CONCLUSION CODE UPDATED TO D15. 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. 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 AXIUM PRIME COIL PREMATURELY DETACHED IN THE MICROCATHETER. THE COIL AND CATHETER WERE REMOVED, AND NO SURGICAL OR MEDICAL INTERVENTIONS WERE REQUIRED. THE PUSHWIRE WAS NOT BENT OR BROKEN. THERE HAD BEEN NO FRICTION OR DIFFICULTY DURING DELIVERY, AND THE PHYSICIAN DID NOT REPOSITION THE COIL. NO DETACHMENT ATTEMPTS HAD BEEN MADE, AND THE PHYSICIAN DID NOT ROTATE THE DELIVERY PUSHER DURING THE PROCEDURE. A CONTINUOUS FLUSH WAS ADMINISTERED. THE PATIENT DID NOT EXPERIENCE ANY INJURY OR COMPLICATIONS. THE DEVICES WERE PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THE PATIENT WAS UNDERGOING TREATMENT FOR AN UNRUPTURED, SACCULAR ANEURYSM LOCATED IN THE MIDDLE CEREBRAL ARTERY. THE MAX DIAMETER WAS 4MM, AND THE NECK DIAMETER WAS 2MM. THE PATIENT'S BLOOD FLOW WAS NORMAL, AND THE VESSEL TORTUOSITY WAS MODERATE. ANCILLARY DEVICES INCLUDE AN ENVOY DA GUIDE CATHETER AND STRYKER SL-10 MICROCATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    514634 AXIUM PRIME BRPL 3D DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION KRD MICRO THERAPEUTICS, INC. DBA EV3 APB-2.5-4-3D-ES B112955 00847536031906

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR