BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GALAXY G3 MINI 2MM X 4CM

    MDR report key: 17598760 · Received August 22, 2023

    Report

    Report Number
    3008114965-2023-00588
    Event Type
    Malfunction
    Date Received
    August 22, 2023
    Date of Event
    August 9, 2023
    Report Date
    August 22, 2023
    Manufacturer
    CERENOVUS, INC.
    Product Code
    KRD
    UDI-DI
    10886704080305
    PMA / PMN Number
    K171862
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER¿S REF. NO: (B)(4). INFORMATION REGARDING PATIENT IDENTIFIER, DATE OF BIRTH, AGE, GENDER, WEIGHT, RACE, AND ETHNICITY WERE NOT PROVIDED. SECTION D.2B: PROCODE IS KRD/HCG. SECTION E.1: THE INITIAL REPORTER PHONE: (B)(6). THE INITIAL REPORTER EMAIL ADDRESS WAS NOT AVAILABLE / REPORTED. BASED ON COMPLAINT INFORMATION, THE DEVICE IS NOT AVAILABLE TO BE RETURNED FOR ANALYSIS. A REVIEW OF MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT (30865673) PRESENTED NO ISSUES DURING THE MANUFACTURING OR INSPECTION PROCESSES RELATED TO THE REPORTED COMPLAINT. THERE WERE NO NONCONFORMANCES RELATED TO DEVICE MANUFACTURE OR INSPECTION. PRODUCT ANALYSIS CANNOT BE CONDUCTED AS THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. NO DETERMINATION OF CAUSES AND POSSIBLE CONTRIBUTING FACTORS COULD BE MADE. AS SUCH, THE INVESTIGATION WILL BE CLOSED. WITH THE INFORMATION AVAILABLE AND WITHOUT THE COMPLAINT PRODUCT AVAILABLE TO BE RETURNED FOR ANALYSIS, THE REPORTED ISSUE DOCUMENTED IN THE COMPLAINT CANNOT BE CONFIRMED THROUGH FUNCTIONAL EVALUATION AND ANALYSIS. BASED ON THE MANUFACTURING DOCUMENTATION REVIEW, THERE IS NO INDICATION THAT THE EVENT IS RELATED TO THE DEVICE MANUFACTURING PROCESS. ASSIGNMENT OF ROOT CAUSE FOR THE EVENT REMAINS SPECULATIVE AND INCONCLUSIVE, BASED ON THE LIMITED INFORMATION PROVIDED AND WITHOUT THE RETURN OF THE COMPLAINT SAMPLE; HOWEVER, IT IS POSSIBLE THAT CLINICAL AND PROCEDURAL FACTORS, INCLUDING DEVICE MANIPULATION / INTERACTION MAY HAVE CONTRIBUTED TO THE REPORTED FAILURE. AS PART OF THE POST MARKET SURVEILLANCE PROGRAM, INFORMATION FROM THIS COMPLAINT IS TRENDED FOR STATISTICAL SIGNALS AND CORRECTIVE / PREVENTIVE ACTION MAY BE TRIGGERED AT A LATER TIME. SINCE THERE WAS NO EVIDENCE TO SUGGEST THE EVENT WAS RELATED TO A MANUFACTURING OR DESIGN ISSUE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. THIS IS ONE OF 2 PRODUCTS INVOLVED WITH THE REPORTED COMPLAINT. THE ASSOCIATED MANUFACTURER REPORT NUMBERS ARE: 3008114965-2023-00587 AND 3008114965-2023-00588. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY CERENOVUS, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, CERENOVUS, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. MISSING INFORMATION FROM THIS REPORT IS IDENTIFIED AS BLANK; THIS INFORMATION WAS NOT PROVIDED IN THE REPORTED EVENT OR AVAILABLE AT THE TIME OF REPORT SUBMISSION. THE MANUFACTURER WILL SUBMIT A SUPPLEMENTAL REPORT IF NEW FACTS ARISE WHICH MATERIALLY ALTER INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 0

    THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A STENT-ASSISTED COIL EMBOLIZATION PROCEDURE, WHEN 3/5 OF A 4MM X 23MM ENTERPRISE 2 (ENCR402312 / 7212914) WAS RELEASED, THE STENT TIP DID NOT OPEN OR EXPAND AS INTENDED. THE PHYSICIAN REMOVED THE STENT AND THE MICROCATHETER, A 150CM X 5CM PROWLER SELECT PLUS MICROCATHETER (606S255X / 31007918) FROM THE PATIENT¿S ANATOMY AND OBSERVED THAT THE MICROCATHETER HAD BECOME KINKED / BENT. THE PHYSICIAN SWITCHED TO NEW DEVICES AND CONTINUED THE PROCEDURE. THE SECOND STENT WAS SEMI-RELEASED IN THE PATIENT, AND COILS WERE USED TO FILL THE ANEURYSM. WHEN THE PHYSICIAN WAS DELIVERING THE THIRD COIL, A 2.00MM X 4.00CM GALAXY G3 MINI (GLM920040 / 30865673), IN THE ANEURYSM, THE COIL WAS FOUND TO HAVE BECOME UNRAVELED / STRETCHED. A NEW COIL WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION. ON (B)(6) 2023, ADDITIONAL INFORMATION WAS RECEIVED. THE INFORMATION INDICATED THAT THE TARGET ANEURYSM WAS A 4MM X 3.5MM X 3.8MM UNRUPTURED ANEURYSM. THERE WERE NO VESSEL NOR ANEURYSM FACTORS THAT MAY HAVE CONTRIBUTED TO THE INCOMPLETE EXPANSION. THE TEMPERATURE INDICATOR LABEL ON THE INNER POUCH HAD BEEN CHECKED AND FOUND TO BE WITHIN ACCEPTABLE CRITERIA. THERE HAD BEEN NO RESISTANCE DURING THE ADVANCEMENT OF THE STENT. THE INFORMATION INDICATED THAT THE SECOND STENT USED WAS ANOTHER 4MM X 23MM ENTERPRISE 2 (ENCR402312) AND THE REPLACEMENT MICROCATHETER WAS ANOTHER 150CM X 5CM PROWLER SELECT PLUS MICROCATHETER (606S255X). THE INFORMATION INDICATED THAT THE COMPLAINT COIL HAD BEEN WITHDRAWN AND REPOSITIONED TWO TIMES. THE PHYSICIAN WAS RETRACTING THE COIL WHEN IT BECAME UNRAVELED / STRETCHED. THE MICROCATHETER WAS NOT REPOSITIONED OVER THE COIL WHILE THE COIL WAS DEPLOYED OR PARTIALLY DEPLOYED OUT OF THE DISTAL END OF THE MICROCATHETER. A ONE-TO-ONE RELATIONSHIP BETWEEN THE COIL AND DELIVERY WIRE WAS VERIFIED WITH FLUOROSCOPY PRIOR TO REPOSITIONING. INFORMATION RELATED TO SUSPECTED POSSIBLE COIL ENTANGLEMENT WITH PREVIOUSLY PLACED COIL COULD NOT BE OBTAINED. THERE WAS NO ADDITIONAL DAMAGE NOTED ON THE COIL ASIDE FROM THE REPORTED UNRAVELED / STRETCHED CONDITION WHEN IT WAS REMOVED. THE REPLACEMENT COIL WAS ANOTHER 2.00MM X 4.00CM GALAXY G3 MINI (GLM920040). THERE WAS NO EVIDENCE OF OBSTRUCTED BLOOD FLOW DUE TO THE REPORTED ISSUE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. THE ADDITIONAL INFORMATION CONFIRMED THERE WAS NO NEGATIVE PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    55933 GALAXY G3 MINI 2MM X 4CM NEUROVASCULAR EMBOLIZATION DEVICE KRD CERENOVUS, INC. 30865673 10886704080305

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown ENTERPRISE2 4MMX23MM| PROWLER SELECT PLUS 150/5CM