BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 21068858 · Received January 3, 2025

    Report

    Report Number
    1649833-2025-00076
    Event Type
    Injury
    Date Received
    January 3, 2025
    Report Date
    March 6, 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
    LA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    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

    THE MANUFACTURING RECORDS FOR CXL-20-1838-20 LOT Z226008100 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. ACCORDING TO THE CHORD-X IFU (INSTRUCTIONS FOR USE) IT IS SPECIFICALLY RECOMMENDED : ¿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.¿ AS THE SURGEON DESCRIBED IN THIS CASE OF CHORD DETACHMENT, SHE USED METAL KNOT PUSHERS TO TIE DOWN THE PAPILLARY STITCH AND DURING THE IN-SERVICE IT WAS RELAYED AND SHE AGREED THAT FINGER TYING WOULD BE A BETTER PROCEDURE VS. USING METAL KNOT PUSHERS. THE ROOT CAUSE OF THE CHORD-X SYSTEM DETACHING FROM THE PAPILLARY MUSCLE IS MOST LIKELY THE USE OF THE METAL KNOT PUSHERS THAT MAY HAVE HAD BURRS OR FLASHING THAT ADVERSELY AFFECTED THE TENSILE STRENGTH OF THE CHORD-X SUTURE. THE CORRECTIVE ACTION WAS TO PERFORM THE IN-SERVICE AND WET LAB FOR THE SURGEON AND STAFF, THIS WAS SUCCESSFULLY ACCOMPLISHED AS EVIDENCED BY THE SURGEON AND TEAM SUCCESSFULLY PERFORMING AN ANTERIOR MITRAL REPAIR DURING THE WET LAB. THEY WERE ALSO GIVEN RESOURCES AND CONTACT INFORMATION FOR FURTHER QUESTIONS. RISK HAS BEEN REDUCED AS LOW AS POSSIBLE AND OVERALL RESIDUAL RISK IS ACCEPTABLE. 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. REFERENCES: ON-X CHORD-X PRE-MEASURED LOOPS AND SUTURE SYSTEM IFU HTTP://WWW.ONXLTI.COM/IFU.

    Description of Event or Problem · 0

    ACCORDING TO THE INITIAL REPORT, AFTER IMPLANT OF THIS CHORD-X DEVICE, IT WAS DISCOVERED THAT THE PAPILLARY STITCH/ARM HAD BEEN CUT/SEVERED AND RELEASED FROM THE PAPILLARY MUSCLE. SURGEON STATED THEY COULD NOT FIND THE PLEDGET THAT SLIPPED OFF THE BROKEN PAPILLARY ANCHOR AND BELIEVED IT MUST HAVE BEEN LOST IN THE PATIENT'S LEFT VENTRICLE.

    Description of Event or Problem · 0

    ACCORDING TO THE INITIAL REPORT, AFTER IMPLANT OF THIS CHORD-X DEVICE, IT WAS DISCOVERED THAT THE PAPILLARY STITCH/ARM HAD BEEN CUT/SEVERED AND RELEASED FROM THE PAPILLARY MUSCLE. SURGEON STATED THEY COULD NOT FIND THE PLEDGET THAT SLIPPED OFF THE BROKEN PAPILLARY ANCHOR AND BELIEVED IT MUST HAVE BEEN LOST IN THE PATIENT'S LEFT VENTRICLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    458131 CHORDX 2-0 SUT 18MM 3/8CIR 20MM LOOP NONABSORBABLE EXPANDED POLYTETRAFLUOROETHYLENE SURGICAL SUTURE PAW ON-X LIFE TECHNOLOGIES, INC CXL-20-1838-20 Z226008100 00813570020282

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Life Threatening