BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRONOVA BLUE SUTURE UNKNOWN PRODUCT

    MDR report key: 18288938 · Received December 7, 2023

    Report

    Report Number
    2210968-2023-09602
    Event Type
    Injury
    Date Received
    December 7, 2023
    Date of Event
    June 28, 2023
    Report Date
    December 7, 2023
    Manufacturer
    ETHICON INC.
    Product Code
    GAW
    PMA / PMN Number
    K001625
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT#: (B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ETHICON INC, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON INC, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. PLEASE CLARIFY IF THE PRONOVA SUTURE CAUSED OR CONTRIBUTED TO THE DEATHS EXPERIENCED IN THESE 3 JOURNAL ARTICLES. PLEASE CLARIFY IF THE PRONOVA SUTURE CAUSED OR CONTRIBUTED TO THE COMPLICATIONS EXPERIENCED IN THESE 3 JOURNAL ARTICLES. WERE THE PATIENTS THAT DIED IN ALL 3 JOURNAL ARTICLES THE SAME EXACT PATIENTS? PLEASE CLARIFY WHICH PATIENTS OR HOW MANY PATIENTS THAT UNDERWENT SUTURED ANASTOMOSES WITH PRONOVA EXPERIENCED COMPLICATIONS/DEATH? DOES THE SURGEON/AUTHOR BELIEVE THAT ANY OF THE ETHICON PRODUCTS INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS/DEATH DESCRIBED IN THE ARTICLE? WHICH SPECIFIC ETHICON PRODUCTS HAVE BEEN USED DURING THE PROCEDURES (PRODUCT CODE, LOT NUMBER)? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH ANY OF THE ETHICON PRODUCTS USED IN THIS PROCEDURE? IF SO, PLEASE PROVIDE DETAILS. WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. PATIENT DEMOGRAPHICS? HAS AN AUTOPSY BEEN PERFORMED FOR DEATH CASES? IF SO, CAN THE RESULTS BE SHARED? WOULD THE JOURNAL AUTHOR / PHYSICIAN LIKE TO SPEAK WITH ETHICON MEDICAL SAFETY AND ENGINEERING VIA SCHEDULED CONFERENCE CALL REGARDING THE PRODUCT INVOLVED IN THIS EVENT? THIS REPORT IS RELATED TO A JOURNAL ARTICLE; THEREFORE, NO PRODUCT WILL BE RETURNED FOR ANALYSIS AND THE BATCH HISTORY RECORDS CANNOT BE REVIEWED AS THE LOT NUMBER HAS NOT BEEN PROVIDED. H6 COMPONENT CODE: G07002 ¿ DEVICE NOT RETURNED. THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. RELATED EVENTS CAPTURED VIA: 2210968-2023-09601. CITATION: JOURNAL OF SURGICAL RESEARCH NOVEMBER 2023 (291) 139-150; HTTPS://DOI.ORG/10.1016/J.JSS.2023.04.030.

    Description of Event or Problem · 0

    TITLE: ROBOTIC TOTALLY ENDOSCOPIC CORONARY BYPASS TO THE LEFT ANTERIOR DESCENDING. ARTERY: LEFT VERSUS RIGHT INTERNAL THORACIC ARTERY GRAFTS. THIS STUDY SOUGHT TO COMPARE OUTCOMES IN OUR ROBOTIC BEATING-HEART TOTALLY ENDOSCOPIC CORONARY BYPASS SURGERY POPULATION BETWEEN PATIENTS WHO RECEIVED LEFT INTERNAL THORACIC ARTERY VERSUS RIGHT INTERNAL THORACIC ARTERY GRAFTS TO THE LEFT ANTERIOR DESCENDING ARTERY. BETWEEN JULY 2013 TO AUGUST 2022, 658 PATIENTS WHO UNDERWENT ROBOTIC OFF-PUMP TOTALLY ENDOSCOPIC CORONARY BYPASS WERE INCLUDED IN THE STUDY. THE PATIENTS WERE DIVIDED INTO 2 GROUPS. GROUP 1 CONSISTED OF 525 PATIENTS (177 FEMALES, MEAN AGE 66 YEARS) WHO HAD A GRAFT TO THE LATERAL ANTERIOR DESCENDING ARTERY USING A LEFT INTERNAL THORACIC ARTERY CONDUIT AND GROUP 2 CONSISTED OF 133 PATIENTS (29 FEMALES, MEAN AGE 29 YEARS) WHO HAD A GRAFT USING RIGHT INTERNAL THORACIC ARTERY. FOR THE ANASTOMOTIC PROCEDURE, A COMPETITOR DISTAL ANASTOMOTIC DEVICE (MANUFACTURER: AESCULAP) WAS USED PREDOMINANTLY (GROUP 1 N= 282, GROUP 2 N=71). DUE TO CESSATION OF PRODUCTION OF THIS DEVICE, PROCEDURE WAS TRANSITIONED TO A SUTURED ANASTOMOTIC TECHNIQUE (GROUP 1 N=237, GROUP 2 N=62) FOR ALL GRAFTS AROUND JULY 2018. FOR THE RUNNING SUTURED ANASTOMOSES, A SHORT DOUBLE-ARMED 7-0 PRONOVA SUTURE (ETHICON) AND A COMPETITOR CORONARY SHUNT (MANUFACTURER: CHASE MEDICAL) IN THE TARGET VESSEL WERE USED, AND SOMETIMES A SECOND SHUNT WAS USED IN THE INTERNAL THORACIC ARTERY CONDUIT FOR PART OF THE ANASTOMOSIS. TRANSIT TIME FLOWMETRY IS CHECKED ON ALL ANASTOMOSES AFTER COMPLETION USING THE COMPETITOR MEDISTIM DEVICE (MANUFACTURER: MEDISTIM). THE PERICARDIUM WAS ROUTINELY LOOSELY CLOSED AT THE END OF THE PROCEDURE. REPORTED COMPLICATIONS INCLUDED MYOCARDIAL INFARCTION (N=?), BLEEDING (N=?), NEED FOR REPEAT LEFT ANTERIOR DESCENDING ARTERY REVASCULARIZATION (N=?) AND CARDIAC-RELATED MORTALITY (N=?). IN CONCLUSION, GRAFTING THE LEFT ANTERIOR DESCENDING ARTERY WITH THE LEFT INTERNAL THORACIC ARTERY OR RIGHT INTERNAL THORACIC ARTERY DURING ROBOTIC BEATING-HEART TOTALLY ENDOSCOPIC CORONARY BYPASS SURGERY RESULTED IN SIMILAR EARLY OUTCOMES AND ANGIOGRAPHIC PATENCY. RIGHT INTERNAL THORACIC ARTERY - LEFT ANTERIOR DESCENDING ARTERY PATIENTS WERE MORE LIKELY TO HAVE MULTIVESSEL DISEASE AND HIGHER SOCIETY OF THORACIC SURGEONS RISK AND HAD HIGH ER ALL-CAUSE MORTALITY AT MID-TERM ANALYSIS BUT NO DIFFERENCE IN MAJOR ADVERSE CARDIAC/CEREBROVASCULAR EVENTS, INCLUDING CARDIAC MORTALITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1127814 PRONOVA BLUE SUTURE UNKNOWN PRODUCT SUTURE, NON ABSORBABLE GAW ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention