BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CHORD-X 2.0 SUT 18MM 1/2CIR 20MM LOOP

    MDR report key: 17930346 · Received October 13, 2023

    Report

    Report Number
    1649833-2023-00040
    Event Type
    Injury
    Date Received
    October 13, 2023
    Date of Event
    October 2, 2023
    Report Date
    December 15, 2023
    Manufacturer
    ON-X LIFE TECHNOLOGIES, INC.
    Product Code
    PAW
    UDI-DI
    00813570020237
    PMA / PMN Number
    K141060
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE MANUFACTURING RECORDS FOR LOT NUMBER Z206031400 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. ARTIVION RECEIVED THE PRODUCT BACK AND ATTEMPTED A SAMPLE EVALUATION. 2 OF THE 5 REMAINING CHORD-X LOOPS WERE RETURNED TO ARTIVION FOR EXAMINATION. UPON RECEIPT, THE SAMPLES WERE VISUALLY EXAMINED AND NO DEFICIENCIES WERE NOTED. DUE TO THE LACK OF INFORMATION/EVIDENCE, THE EXACT MODE OF FAILURE IS NOT CLEAR. IF THE SAMPLE THAT FAILED WAS RETURNED OR PHOTOGRAPHED, THE FAILURE MODE MAY HAVE BEEN DETERMINED AND FURTHER TESTING COULD BE PERFORMED TO REPLICATE IT. WITHOUT KNOWLEDGE OF THE EXACT NATURE OF THE FAILURE, EXPLORATORY TESTING OF THE REMAINING SAMPLES COULD LEAD TO MISLEADING RESULTS. IN ADDITION, IT IS UNLIKELY THAT THE SUTURE FAILURE OCCURRED DUE TO INSUFFICIENT TENSILE STRENGTH. SUTURE STRENGTH TESTING IS PERFORMED BY ARTIVION FOR EACH STERILIZATION LOT OF CHORD-X LOOPS. LOTS MUST RECEIVE PASSING RESULTS BEFORE BEING APPROVED FOR RELEASE TO CUSTOMERS. WITH THE CURRENTLY AVAILABLE INFORMATION/EVIDENCE, THE EXACT MODE OF FAILURE IS NOT EASILY DETERMINABLE, WHICH DISALLOWS THE POSSIBILITY OF EXPLORATORY TESTING. BECAUSE OF THIS, THE ROOT CAUSE IS UNKNOWN AND UNABLE TO BE DETERMINED. THIS REPORTED EVENT DOES NOT HAVE PATIENT IMPACT; THEREFORE, A RISK REPORT IS NOT REQUIRED. HOWEVER, THE CHORD-X FILE WAS REVIEWED. THE RISK FILE THOROUGHLY IDENTIFIES THE PROCESS AND PRODUCT HAZARDS FOR APPROVED INDICATIONS. EACH INDIVIDUAL HAZARD IS MITIGATED AND REDUCED AS LOW AS POSSIBLE BY DESIGN AND PROCESS. POST PRODUCTION RESIDUAL RISK IS COMMUNICATED IN THE PRODUCT'S LABELING AND IFU (INSTRUCTIONS FOR USE). A ROOT CAUSE COULD NOT BE DETERMINED. 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. THERE IS NO INDICATION THAT AN ERROR OR DEFICIENCY OCCURRED AT ARTIVION, PREVIOUSLY CRYOLIFE/JOTEC. FIELD ASSURANCE WILL CONTINUE TO MONITOR SIMILAR COMPLAINTS TO DETERMINE IF ADDITIONAL ACTIONS ARE WARRANTED; HOWEVER, AT THIS TIME NO FURTHER ACTIONS ARE NECESSARY. NO ACTIONS ARE REQUIRED AT THIS TIME. 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

    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. SECTION D4 UPDATED: UDI NUMBER AND EXPIRATION DATE ADDED.

    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.

    Description of Event or Problem · 0

    ACCORDING TO INITIAL NOTIFICATION, "AFTER REPAIR OF MITRAL VALVE WITH CHORD-X, THE SURGEON DONE WATER TEST AND NOTICED A SPONTANEOUS BROKEN OF CHORD-X AND A LOSS OF PLEDGET. HE TRIED TO RECOVER THE PLEDGET WITH THE HELP OF ENDOSCOPE IN VENTRICLE WITHOUT SUCCESS, THE PLEDGET IS NOW MISSING."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    631482 CHORD-X 2.0 SUT 18MM 1/2CIR 20MM LOOP NONABSORBABLE EXPANDED POLYTETRAFLUOROETHYLENE SURGICAL SUTURE FOR CHORDAE TENDI PAW ON-X LIFE TECHNOLOGIES, INC. CXL-20-1812-20 00813570020237

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Life Threatening