BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CHORDX 2-0 SUT 18MM 3/8CIR 20MM LOOP

    MDR report key: 21921721 · Received April 28, 2025

    Report

    Report Number
    1649833-2025-00010
    Event Type
    Injury
    Date Received
    April 28, 2025
    Date of Event
    April 1, 2025
    Report Date
    June 20, 2025
    Manufacturer
    ON-X LIFE TECHNOLOGIES, INC.
    Product Code
    PAW
    UDI-DI
    00813570020282
    PMA / PMN Number
    K141060
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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- FORMERLY CRYOLIFE/JOTEC IS ACCURATE OR HAS BEEN CONFIRMED BY ARTIVION.

    Additional Manufacturer Narrative · 0

    A SAMPLE EVALUATION WAS NOT PERFORMED AS THE DEVICE WAS NOT RELEASED FOR RETURN. THE MANUFACTURING RECORDS WERE REVIEWED AND IT WAS CONFIRMED THAT ALL RECORDS WERE CONTROLLED, AVAILABLE FOR REVIEW, AND MET ALL SPECIFICATIONS PER THE DEVICE MASTER RECORD. ALL LOTS PASSED FUNCTIONAL TESTING AND MET RELEASE SPECIFICATIONS. DURING THE INVESTIGATION NO NON-CONFORMANCES OR DEVIATIONS WERE NOTED. THIS IS A CASE OF MITRAL VALVE REPAIR USING THE CHORD-X SUTURE SYSTEM ON 01APR2025 IN A PATIENT OF UNKNOWN AGE AND GENDER. ACCORDING TO THE REPORT DURING THE MITRAL VALVE REPAIR WITH THE CHORD-X PRODUCT THE ANCHORING SUTURE ON THE PAPILLARY MUSCLE RIPPED THROUGH RESULTING IN THE VALVE HAVING TO BE REPLACED. THE SURGERY WAS CONVERTED TO A MITRAL VALVE REPLACEMENT WITH AN ON-X MITRAL VALVE. AN INVESTIGATION WAS OPENED, AND ADDITIONAL INFORMATION WAS REQUESTED. THE REPORTING SALES REP PROVIDED ADDITIONAL INFORMATION THAT THE SUTURES ALL BROKE ABOVE THE PLEDGETS AT THE BASE OF THE PAPILLARY MUSCLE. THE LEAFLET AND PAPILLARY MUSCLE SUTURES WERE INTACT AND NEEDED TO BE REMOVED PRIOR TO IMPLANTING THE MECHANICAL MITRAL VALVE. THE PRODUCT WAS NOT RETURNED FOR INSPECTION AND NO MEDICAL RECORDS WERE PROVIDED. 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 WITHIN 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 THAN 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. IN ADDITION, THE PRODUCT IS INSPECTED UPON ARRIVAL ACCORDING TO SOP AND TESTS ARE CONDUCTED ON THE TENSILE STRENGTH OF THE SUTURE AND NEEDLE ATTACHMENT ACCORDING TO SOP TO ENSURE THEY MEET EUP AND U.S.P REQUIREMENTS FOR NON-ABSORBABLE STERILE SUTURE. IT WAS DETERMINED THAT A PLAUSIBLE EXPLANATION OF THE SUTURE BREAKAGE IS IMPROPER HANDLING OF THE SUTURE MATERIAL SUCH AS USING KNOT PUSHERS WITH IMPERFECTIONS LEADING TO BREAKAGE AND FAILURE OF THE CHORD-X SUTURE SYSTEM. THIS IS ADDRESSED IN THE IFU ¿MISUSE OF THIS SUTURE PROSTHESIS, LIKE ANY OTHER SUTURE, CAN RESULT IN SEVERE INJURY OR DEATH TO THE PATIENT. AS WITH ANY SUTURE, CARE SHOULD BE TAKEN TO AVOID DAMAGE WHEN HANDLING. AVOID CRUSHING OR CRIMPING THE SUTURE WITH SURGICAL INSTRUMENTS OR EXPOSING THE SUTURE TO SHARP EDGES, WHICH MAY ADVERSELY AFFECT THE TENSILE STRENGTH OF THE SUTURE. AVOID USING KNOT PUSHERS WITH IMPERFECTIONS SUCH AS BURRS OR FLASHING WHICH MAY DAMAGE THE SUTURE.¿ 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, A PLAUSIBLE EXPLANATION OF THE SUTURE BREAKAGE WAS IMPROPER HANDLING OF THE SUTURE MATERIAL SUCH AS USING KNOT PUSHERS WITH IMPERFECTIONS LEADING TO BREAKAGE AND FAILURE OF THE CHORD-X SUTURE SYSTEM. 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- FORMERLY CRYOLIFE/JOTEC IS ACCURATE OR HAS BEEN CONFIRMED BY ARTIVION.

    Description of Event or Problem · 0

    ACCORDING TO THE REPORT, THE CHORD-X SUTURES ALL BROKE ABOVE THE PLEDGETS AT THE BASE OF THE PAPILLARY MUSCLE, RESULTING IN THE PATIENT'S VALVE NEEDING REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1427768 CHORDX 2-0 SUT 18MM 3/8CIR 20MM LOOP NONABSORBABLE EXPANDED POLYTETRAFLUOROETHYLENE SURGICAL SUTURE PAW ON-X LIFE TECHNOLOGIES, INC. CXL-20-1838-20 Z226014500 00813570020282

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other