BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CHORD-X 2-0 SUT 18MM 1/2CIR 16MM LOOP

    MDR report key: 23934346 · Received December 31, 2025

    Report

    Report Number
    1649833-2025-00045
    Event Type
    Injury
    Date Received
    December 31, 2025
    Date of Event
    December 12, 2025
    Report Date
    February 25, 2026
    Manufacturer
    ON-X LIFE TECHNOLOGIES, INC.
    Product Code
    PAW
    UDI-DI
    00813570020220
    PMA / PMN Number
    K141060
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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 NO PRODUCT WAS RETURNED. 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 PERFORMED ON (B)(6) 2025 IN A PATIENT OF UNKNOWN AGE AND GENDER. THE PROCEDURE WAS A COMPLEX BARLOW REPAIR USING CHORD-X PRODUCT. ACCORDING TO THE INITIAL REPORT, DURING THE MITRAL VALVE REPAIR THE CHORD-X SUTURE BROKE AT THE PAPILLARY MUSCLE LEVEL AFTER THE CLAMP WAS REMOVED. THE PAPILLARY MUSCLE WAS INTACT, AND THE SUTURE FAILURE OCCURRED ON THE PRELOADED LOOP SIDE, NOT AT THE KNOT. THE SUTURE WAS HAND-TIED, AND THE SURGEON STATED THAT NO KNOT PUSHER WAS USED AND HE DID NOT BELIEVE THE SUTURE WAS NICKED BY SURGICAL INSTRUMENTS. THE SURGEON NOTED THAT THE SUTURE MAY HAVE BEEN SUBJECTED TO REPEATED ADJUSTMENTS AT THE LEAFLET LEVEL PRIOR TO FAILURE. FOLLOWING THE SUTURE BREAKAGE, THE SURGEON RETURNED THE PATIENT TO CARDIOPULMONARY BYPASS, IDENTIFIED ONE PLEDGET, WHILE THE SECOND PLEDGET COULD NOT BE LOCATED. A RE-REPAIR WAS SUCCESSFULLY PERFORMED USING A NEW CHORD-X SUTURE, RESULTING IN AN OPTIMAL VALVE REPAIR. DUE TO CONCERN FOR EMBOLIZATION, THE PATIENT WAS TAKEN TO CT IMAGING AND SUBSEQUENTLY TO THE CATHETERIZATION LAB FOR SNARING OF THE MISSING PLEDGET. THE PROCEDURE CONCLUDED SUCCESSFULLY, AND THE PATIENT IS REPORTED TO BE DOING WELL. THE EXPLANTED CHORD-X SUTURES WERE NOT RETAINED AND WERE UNAVAILABLE FOR INSPECTION, AND NO MEDICAL RECORDS WERE PROVIDED. ACCORDING TO THE PROVIDED REPORTS DURING PRODUCT DEVELOPMENT, FATIGUE TESTING OF THE CHORD-X EPTFE SUTURE MATERIAL WAS PERFORMED UNDER LOAD FOR 10 MILLION CYCLES WITH A SAMPLE SIZE OF ONE, SUPPORTING AN INFERRED 99-YEAR EXPECTED LIFETIME. A SECOND ROUND OF FATIGUE TESTING ON IRREGULAR SUTURE MATERIAL DEMONSTRATED 3% ELONGATION (ACCEPTANCE CRITERION <10%). A THIRD ROUND OF FATIGUE TESTING IS CURRENTLY UNDERWAY USING A SAMPLE SIZE OF 16 SUTURES EXPOSED TO 400 MILLION CYCLES. ADDITIONALLY, CHORD-X PRODUCTS UNDERGO INCOMING INSPECTION AND TENSILE STRENGTH AND NEEDLE ATTACHMENT TESTING. WITH THE LIMITED INFORMATION PROVIDED AND DUE TO THE PRODUCT NOT BEING RETURNED FOR EVALUATION, A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. POTENTIAL CONTRIBUTING FACTORS MAY INCLUDE REPEATED MANIPULATION OF THE SUTURE DURING LEAFLET ADJUSTMENT AS DESCRIBED BY THE IMPLANTING SURGEON. INSTRUMENT DAMAGE WAS NOT SUSPECTED IN THIS CASE BY THE IMPLANTING SURGEON BUT CANNOT BE DEFINITIVELY RULED OUT. 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 INITIAL REPORT, THE CHORD-X SUTURE BROKE DOWN AT THE PAPILLARY MUSCLE LEVEL. THE SUTURE BROKE AFTER THE CLAMP CAME OFF SO HE HAD HE TO GO BACK ON, FOUND ONE OF THE PLEDGETS BUT THE OTHER ONE WAS GONE. HE DID A RE-REPAIR WITH CHORD X AGAIN AND WAS PERFECT BUT HAD TO GO TO CT TO GO SEARCHING AROUND FOR THIS PLEDGET. NEEDED CATH LAB SNARING AND FINALLY ENDED WELL AND PTS IS DOING GREAT. THEY DID NOT KEEP THE EXPLANTED CHORDS FOR EXAMINATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    204577 CHORD-X 2-0 SUT 18MM 1/2CIR 16MM LOOP NONABSORBABLE EXPANDED POLYTETRAFLUOROETHYLENE SURGICAL SUTURE PAW ON-X LIFE TECHNOLOGIES, INC. CXL-20-1812-16 Z233001600 00813570020220

    Patients

    Seq Age Sex Outcome Treatment
    1