BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CHORDX UNKNOWN

    MDR report key: 18474976 · Received January 9, 2024

    Report

    Report Number
    1649833-2024-00001
    Event Type
    Injury
    Date Received
    January 9, 2024
    Date of Event
    October 25, 2023
    Report Date
    February 27, 2024
    Manufacturer
    ON-X LIFE TECHNOLOGIES, INC.
    Product Code
    PAW
    PMA / PMN Number
    K141060
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS INVESTIGATION IS CURRENTLY ONGOING. ANY ADDITIONAL INFORMATION WILL BE PROVIDED IN THE FOLLOW-UP REPORT. THIS REPORT IS BEING SUBMITTED AS REQUIRED BY FEDERAL REGULATIONS AND DOES NOT CONSTITUTE AN ADMISSION THAT THE DEVICE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. FURTHERMORE, THIS REPORT REFLECTS THE EVENT AS ALLEGED BY THE COMPLAINANT AND DOES NOT IMPLY THAT THE INFORMATION REPORTED TO ARTIVION IS ACCURATE OR HAS BEEN CONFIRMED BY ARTIVION.

    Additional Manufacturer Narrative · 0

    A REVIEW OF MANUFACTURING RECORDS COULD NOT BE COMPLETED, AS THE LOT NUMBER WAS UNKNOWN. THE AVAILABLE INFORMATION WAS REVIEWED. THIS INFORMATION WAS RECEIVED FROM THE SURGEON DURING A DISCUSSION ABOUT THE CHORD-X PRODUCT ON (B)(6) 2024. THIS IS A CASE OF MITRAL VALVE REPAIR USING THE CHORD-X ADJUSTABLE SUTURE SYSTEM ON (B)(6) 2021 IN A MALE PATIENT OF UNKNOWN AGE, THE SURGEON DID NOT HAVE THE LOT OR BATCH NUMBER FOR THE USED PRODUCT. ACCORDING TO THE SURGEON THE MITRAL VALVE REPAIR WAS INITIALLY SUCCESSFUL, AND THE POST OPERATIVE AND 30-DAY ECHOCARDIOGRAMS SHOWED A SUCCESSFUL MITRAL VALVE REPAIR WITH NO MITRAL REGURGITATION. THEN ON (B)(6) 2023 (805 DAYS POST REPAIR) THE PATIENT UNDERWENT A RE-DO MITRAL VALVE REPAIR DUE TO MITRAL REGURGITATION. DURING THE SURGERY IT WAS DISCOVERED THAT THE CHORD-X ADJUSTABLE SUTURE HAD FRACTURED ON THE INNER LOOP. THERE WERE STILL 3 LOOPS ATTACHED TO THE LEAFLET, HOWEVER THE LOOP ATTACHED TO THE PAPILLARY MUSCLE HAD FRACTURED CAUSING THE MITRAL VALVE TO NO LONGER COAPT PROPERLY RESULTING IN REGURGITATION. THE SURGEON SPECIFIED THAT THE PLEDGETS ON THE PAPILLARY MUSCLE WERE STILL IN PLACE AS WELL. HE DID NOT SUPPLY MEDICAL RECORDS, PICTURES, OR ANY FURTHER INFORMATION. THE PRODUCT WAS DISCARDED AT THE TIME OF REMOVAL AND WILL NOT BE RETURNED FOR EVALUATION. PER THE SURGEON THE PATIENT IS CURRENTLY ¿DOING WELL¿. DURING THE INVESTIGATION ENGINEERING WAS CONSULTED REGARDING FATIGUE TESTING PERFORMED ON THE PRODUCT. ACCORDING TO THE PROVIDED REPORTS DURING PRODUCT DEVELOPMENT A FATIGUE TEST WAS PERFORMED ON A SAMPLE SIZE OF 1, IT WAS PERFORMED UNDER LOAD AND AT 10 MILLION CYCLES. USING THESE RESULTS, IT WAS INFERRED THAT THE PHYSIOLOGICAL LOADS THAT WOULD BE EXERTED ON THE SUTURE WOULD BE WELL WITHING THE LIMITS AND A 99-YEAR EXPECTED LIFETIME. THERE WAS A SECOND ROUND OF TESTING PERFORMED ON IRREGULAR SUTURES AS WELL, DUE TO A PREVIOUSLY FOUND ABNORMALITY, AND IT WAS FOUND THAT THE ELONGATION PERCENTAGE WAS 3% (SHOULD BE LESS THEN 10%) WITH THE IRREGULAR MATERIAL. AND IT WAS INFERRED THAT THE IRREGULAR SUTURE MATERIAL WOULD STILL PERFORM AS EXPECTED. AT THIS TIME THERE IS A 3RD ROUND FATIGUE TESTING UNDERWAY WITH A SAMPLE SIZE OF 16 AND THE SUTURE WILL BE EXPOSED TO 400 MILLION CYCLES. CURRENTLY THE SUTURES HAVE UNDERGONE 38 MILLION CYCLES WITH NO ISSUES REPORTED. IN ADDITION, THE PRODUCT IS INSPECTED UPON ARRIVAL AND TESTS ARE CONDUCTED ON THE TENSILE STRENGTH OF THE SUTURE AND NEEDLE ATTACHMENT TO ENSURE THEY MEET REQUIREMENTS FOR NON-ABSORBABLE STERILE SUTURE. AFTER REVIEW OF THE AVAILABLE INFORMATION, IT WAS DETERMINED THAT THE MOST LIKELY CAUSE OF THE SUTURE BREAKAGE WAS A POSSIBLE REPEATED CROSSOVER OF THE SUTURE LINES SECONDARY TO PATIENT ANATOMY AND/OR IMPLANTATION TECHNIQUE, THIS FRICTION COULD BE THE CAUSE OF INCREASED WEAR LEADING TO BREAKAGE AND FAILURE OF THE CHORD-X ADJUSTABLE SUTURE SYSTEM. WITH THE LIMITED INFORMATION PROVIDED AND DUE TO THE PRODUCT NOT BEING RETURNED FOR EVALUATION WE ARE UNABLE TO COME TO A CONCLUSIVE ROOT CAUSE. HOWEVER, THE MOST LIKELY CAUSE OF THE SUTURE BREAKAGE WAS A POSSIBLE CROSSOVER OF THE SUTURE LINES SECONDARY TO PATIENT ANATOMY AND/OR IMPLANTATION TECHNIQUE. THE FRICTION CAUSED BY A REPEATED CROSSING OF THE SUTURES COULD LEAD TO INCREASED WEAR LEADING TO BREAKAGE AND FAILURE OF THE CHORD-X ADJUSTABLE SUTURE SYSTEM. NO FURTHER ACTION IS REQUIRED WITHOUT FURTHER INFORMATION. A REVIEW OF THE INFORMATION WAS PERFORMED TO COMPILE A RISK ANALYSIS. WITH THE LIMITED INFORMATION PROVIDED AND DUE TO THE PRODUCT NOT BEING RETURNED FOR EVALUATION WE ARE UNABLE TO COME TO A CONCLUSIVE ROOT CAUSE. HOWEVER, THE MOST LIKELY CAUSE OF THE SUTURE BREAKAGE WAS A POSSIBLE CROSSOVER OF THE SUTURE LINES SECONDARY TO PATIENT ANATOMY AND/OR IMPLANTATION TECHNIQUE. THE FRICTION CAUSED BY A REPEATED CROSSING OF THE SUTURES COULD LEAD TO INCREASED WEAR LEADING TO BREAKAGE AND FAILURE OF THE CHORD-X ADJUSTABLE SUTURE SYSTEM. THERE IS NOT SUFFICIENT DATA TO DETERMINE A FAILURE MODE; THUS, SEVERITY AND OCCURRENCE IS NOT EVALUATED. THERE IS NO INDICATION THAT AN ERROR OR DEFICIENCY OCCURRED AT ARTIVION FORMERLY CRYOLIFE AND ALL RISKS IDENTIFIED HAVE BEEN MITIGATED AS FAR AS POSSIBLE AND RESIDUAL RISK IS ACCEPTABLE. FIELD ASSURANCE WILL CONTINUE TO MONITOR SIMILAR COMPLAINTS TO DETERMINE IF ADDITIONAL ACTIONS ARE WARRANTED; HOWEVER, AT THIS TIME NO FURTHER ACTIONS ARE NECESSARY. THIS REPORT IS BEING SUBMITTED AS REQUIRED BY FEDERAL REGULATIONS AND DOES NOT CONSTITUTE AN ADMISSION THAT THE DEVICE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. FURTHERMORE, THIS REPORT REFLECTS THE EVENT AS ALLEGED BY THE COMPLAINANT AND DOES NOT IMPLY THAT THE INFORMATION REPORTED TO ARTIVION IS ACCURATE OR HAS BEEN CONFIRMED BY ARTIVION.

    Description of Event or Problem · 0

    ACCORDING TO INITIAL NOTIFICATION EMAIL FROM "FIRST MITRAL VALVE REPAIR SURGERY WAS PERFORMED (B)(6) 2021, USING CHORD-X ADJUSTABLE SUTURE SYSTEM. POST OP ECHO AND 30 DAY ECHO SHOWED SUCCESSFUL MITRAL VALVE REPAIR WITH NO MITRAL REGURGITATION. 2 YEARS 2 MONTHS LATER THE PATIENT EXPERIENCED MITRAL REGURGITATION. THE PAPILLARY MUSCLE LOOP DETACHED LEAVING 3 CHORDS IN PLACE ATTACHED TO LEAFLET, BUT UNATTACHED TO PAPILLARY MUSCLE." ADDITIONAL INFORMATION RECEIVED 01/05/2024: THE PATIENT IS DOING WELL. THE LOT NUMBER WAS UNABLE TO BE OBTAINED. THE PATIENT HAD A MITRAL VALVE REPLACEMENT. IT WAS OBSERVED UPON EXPLANT THAT THE CHORD-X LOOP BROKE, HOWEVER, THE CAUSE IS UNKNOWN. THE PATIENT'S ANATOMY WAS WITHOUT ANOMALY AT IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    649906 CHORDX UNKNOWN NONABSORBABLE EXPANDED POLYTETRAFLUOROETHYLENE SURGICAL SUTURE FOR CHORDAE TENDI PAW ON-X LIFE TECHNOLOGIES, INC. CXL UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Life Threatening