BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CHORDX 2-0 SUT 18MM 1/2CIR 24MM LOOP

    MDR report key: 10734214 · Received October 26, 2020

    Report

    Report Number
    1649833-2020-00043
    Event Type
    Injury
    Date Received
    October 26, 2020
    Date of Event
    September 29, 2020
    Report Date
    December 16, 2020
    Manufacturer
    CRYOLIFE, INC. - KENNESAW
    Product Code
    PAW
    PMA / PMN Number
    K141060
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    A SAMPLE EVALUATION WAS PERFORMED ON RETURNED, UNUSED CHORD-X SUTURES FROM THE SAME LOT. INITIAL REPORT STATES: WHILE SUTURING LEAFLETS THE PAPILLARY SUTURE BROKE. ALL SUTURES WERE REMOVED. THE SURGEON ATTEMPTED A SECOND SUTURE PLACEMENT AND THE SAME EVENT OCCURRED. SURGEON REMOVED SECOND SET OF CHORD-X SUTURES AND USED NON CHORD-X SUTURES. THE SUTURES USED IN THE CASE WERE NOT RETURNED; HOWEVER, TWO (2) UNOPENED BAGS OF SUTURES FROM THE SAME MANUFACTURED LOT WERE RECEIVED AND TESTED. ALL RESULTS PASSED. ON-X ENGINEERING DEPARTMENT SUBMITTED FOLLOW UP QUESTIONS AND THESE WERE ANSWERED BY THE PHYSICIAN AND ARE CAPTURED IN THE CASE. EVEN WITH THIS ADDITIONAL INFORMATION, ROOT CAUSE CANNOT BE DETERMINED WITH ANY DEGREE OF CERTAINTY. THE MANUFACTURING RECORDS FOR CXL-20-1812-24, LOT NUMBER Z206008800 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. ROOT CAUSE COULD NOT BE DETERMINED. THE LOT SPECIFIC SUTURE MATERIAL USED IN CASE MET ALL RELEASE CRITERIA AT THE MANUFACTURER (ZEUS) AND PASSED INSPECTION AND TESTING REQUIREMENTS AT ON-X RI. ADDITIONAL TENSILE TESTING FROM SAME LOT CONDUCTED AS PART OF THE INVESTIGATION WAS ALSO SUCCESSFUL. RISK MANAGEMENT REVIEWED THE AVAILABLE INFORMATION. THERE WERE NO ISSUES FOUND IN THE MANUFACTURE OF THE SUTURE MATERIAL OR IN THE ASSEMBLY OF THE PACKAGED DEVICE. THE ON-X CHORD-X SUTURE FOR CHORDAE TENDINEAE RISK MANAGEMENT FILE THOROUGHLY IDENTIFIES THE PROCESS AND PRODUCT HAZARDS FOR INDICATIONS. EACH INDIVIDUAL HAZARD IS MITIGATED AND REDUCED AS LOW AS POSSIBLE BY DESIGN AND PROCESS. 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 CRYOLIFE IS ACCURATE OR HAS BEEN CONFIRMED BY CRYOLIFE.

    Description of Event or Problem · 0

    THE FOLLOWING QUESTIONS WERE ANSWERED BY THE SURGEON: WHAT WAS THE REASON FOR SURGERY? WAS THE PATIENT BEING PLACED ON ECMO AT ALL RELATED TO THE SURGERY BEING PROLONGED AFTER THE SUTURES BROKE? HOW IS THE PATIENT DOING POST-OPERATIVELY? ANY ADDITIONAL DETAILS OF EXACTLY HOW/WHEN THE SUTURES BROKE WOULD BE HELPFUL FOR OUR CLINICAL/MEDICAL TEAM TO EVALUATE. IF OPERATIVE NOTES ARE AVAILABLE, THAT WOULD BE ESPECIALLY HELPFUL. THE REASON FOR SURGERY WAS SEVERE MITRAL REGURGITATION WITH A PROLAPSE AND FLAIL OF THE ANTERIOR LEAFLET, TRICUSPID REGURGITATION AND CORONARY ARTERY DISEASE. I PERFORMED A MITRAL VALVE REPAIR THAT WAS ULTIMATELY REPLACED AS WELL AS A TRICUSPID VALVE REPAIR AND A CABG X 2. YES, THE PATIENT BEING PLACED ON ECMO WAS MOST LIKELY DUE TO THE PROLONGED OPERATION AND 2 ADDITIONAL CROSS CLAMPS TO RE REPAIR AND THEN REPLACE THE VALVE. THE PATIENT IS DOING WELL AND I HOPE TO DISCHARGE HIM WITHIN THE NEXT FEW DAYS. I USED THE 24MM CHORD-X LOOP SYSTEM TO REPAIR THE ANTERIOR LEAFLET AS I HAVE DONE MANY TIMES PREVIOUSLY. WHEN I TESTED THE VALVE IT LOOKED PERFECT. WHEN WE INITIALLY SEPARATED FROM CARDIOPULMONARY BYPASS THE REPAIR WAS INTACT AND THERE WAS NO RESIDUAL MITRAL REGURGITATION BY TEE EVALUATION. HE HAD PRESERVED LV FUNCTION. I WAS JUST ABOUT TO REMOVE THE AORTIC CANNULA AFTER PROTAMINE HAD BEEN ADMINISTERED THE TEE SHOWED RECURRENT SEVERE MITRAL REGURGITATION WITH RECURRENT ANTERIOR LEAFLET FLAIL. WE RE HEPARINIZED AND WENT BACK ON PUMP AN REARRESTED THE HEART. THE 3 LOOPS WERE INTACT BUT THE SUTURE WITH THE PLEDGETS THAT WAS PLACED IN THE PAPILLARY MUSCLE TIP WAS BROKEN. THE KNOT WAS STILL IN TACT. I REPLACED THE ENTIRE SYSTEM AGAIN WITH ANOTHER 24MM LOOP PACKAGE AND THE SAME SERIES OF EVENTS OCCURRED WITH THE SAME FINDINGS. THE 3RD TIME I REPLACED THE VALVE. THE SURGEON WAS LATER ASKED TO CLARIFY IF THE SUTURE ITSELF BROKE OR IF THE SUTURE PULLED THROUGH THE TISSUE. HE RESPONDED, "SUTURE FRACTURE/BREAK. TISSUE WAS INTACT." A CRYOLIFE REPRESENTATIVE, ASKED THE FOLLOWING QUESTIONS TO THE SURGEON, WHICH WERE ANSWERED: FIRST, CAN YOU CLARIFY WHEN YOU NOTICED THE CHORD-X SUTURE HAD BROKEN? WAS IT DURING THE PLACEMENT OF THE CHORD-X SUTURE INTO THE LEAFLET OR WHEN YOU WERE COMING OFF PUMP OR COMPLETELY OFF PUMP? AND THE SAME QUESTION FOR THE SECOND SET OF CHORD-X THAT WERE PLACED, WHEN DURING THE PROCEDURE DID YOU NOTICE THEY WERE BROKEN? - 1ST NOTICED BROKEN CHORDS WHEN WE CAME OFF PUMP AND SAW RECURRENT MITRAL REGURGITATION. SAME FOR THE SECOND SET. AFTER THE TWO ATTEMPTS USING CHORD-X, DID YOU TRY USING A DIFFERENT SUTURE? IF SO, WHERE WERE THESE SUTURES PLACED? IF NOT, DID YOU END UP REPLACING THE ENTIRE VALVE? NO FURTHER SUTURE ATTEMPTS, I REPLACED THE VALVE. JUST A CONFIRMATION, YOU DID HAVE ISSUES WITH LOOSE PLEDGETS, CORRECT? IF SO, ANY ELABORATION WOULD BE APPRECIATED. - NO ISSUES WITH LOOSE PLEDGETS. WERE ANY SHARP TOOLS USED TO CLAMP OR HANDLE THE CHORD-X SUTURE WHEN TYING THE KNOTS? NO SHARP TOOLS WERE USED. WAS A KNOT PUSHER USED AND IF SO, DO YOU KNOW WHAT TYPE? - NO KNOT PUSHER WAS USED.

    Additional Manufacturer Narrative · 1

    THIS INVESTIGATION IS CURRENTLY ONGOING. ANY ADDITIONAL INFORMATION WILL BE PROVIDED IN THE FOLLOW-UP REPORT.

    Description of Event or Problem · 1

    ACCORDING TO INITIAL REPORT RECEIVED FROM A CRYOLIFE REPRESENTATIVE, "SURGEON ATTEMPTED TO USE CHORD-X. ANCHOR SUTURE PLACED IN PAPILLARY MUSCLE. WHILE SUTURING LEAFLETS THE PAPILLARY SUTURE BROKE. ALL SUTURES WERE REMOVED. THE SURGEON ATTEMPTED A SECOND SUTURE PLACEMENT WITH THE CHORD-X AND THE SAME EVENT OCCURRED. SURGEON REMOVED THE SECOND SET OF CHORD-X SUTURES AND USED NON-CHORD-X SUTURES. PATIENT IS CURRENTLY ON ECMO."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1200843 CHORDX 2-0 SUT 18MM 1/2CIR 24MM LOOP NONABSORBABLE EXPANDED POLYTETRAFLUOROETHYLENE SURGICAL SUTURE PAW CRYOLIFE, INC. - KENNESAW CXL-20-1812-24 Z206008800

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O