BEUDAMED
    FDA Adverse Event Death Summary report: N

    PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT

    MDR report key: 16595100 · Received March 22, 2023

    Report

    Report Number
    2210968-2023-01951
    Event Type
    Death
    Date Received
    March 22, 2023
    Date of Event
    September 27, 2022
    Manufacturer
    ETHICON INC.
    Product Code
    GAW
    PMA / PMN Number
    K133356
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    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. DOES THE SURGEON 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? 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. 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 2210968-2023-01946, 2210968-2023-01947, 2210968-2023-01948, 2210968-2023-01949, 2210968-2023-01950, AND 2210968-2023-01952. CITATION: EUR J CARDIOTHORAC SURG 2022; HTTPS://DOI:10.1093/EJCTS/EZAC467.

    Description of Event or Problem · 0

    TITLE: A TOTALLY ENDOSCOPIC APPROACH FOR AORTIC VALVE SURGERY. THE OBJECTIVE OF THIS STUDY WAS TO DESCRIBE A NEW APPROACH FOR TOTALLY ENDOSCOPIC AORTIC VALVE REPLACEMENT. FROM OCTOBER 2017 THROUGH DECEMBER 2020, 266 PATIENTS WHO UNDERWENT TOTALLY ENDOSCOPIC AORTIC VALVE REPLACEMENT WERE INCLUDED IN THE STUDY. THERE WERE 168 MALES AND 98 FEMALES WITH A MEDIAN AGE OF 82 YEARS AND A MEDIAN BMI OF 27.08 KG/M2. DURING THE PROCEDURE, APPROXIMATELY 12 PLEDGED SUTURES OF ETHIBOND 2¿0 (ETHICON) WERE PLACED IN AN INVERSE MANNER IN THE AORTIC ANNULUS, WHICH IS SUBSEQUENTLY PUT THROUGH THE SEWING RING OF THE EXTRACORPOREAL NON-ETHICON PROSTHETIC VALVE (MANUFACTURER: UNKNOWN). AFTER DETERMINING THE FUNCTION OF THE PROSTHETIC VALVE AND CHECKING THE FREE CORONARY OSTIA, THE ASCENDING AORTA IS CLOSED USING A DOUBLE-LAYERED SUTURE OF PROLENE 4¿0 (ETHICON). ONCE THE PATIENT WAS HAEMODYNAMICALLY STABLE AND TRANSESOPHAGEAL ECHOCARDIOGRAPHY CONFIRMATION SHOWS A GOOD VALVE FUNCTION WITHOUT PARAVALVULAR LEAKAGE, WEANING FROM CARDIOPULMONARY BYPASS WAS INITIATED. IN ALL CASES, THE PERICARDIUM IS APPROXIMATED USING VICRYL 2¿0 (ETHICON) SUTURES; A CHEST TUBE BLAKE DRAIN 19 FR (ETHICON) WAS INTRODUCED THROUGH A TROCAR INCISION INTO THE RIGHT PLEURAL SPACE. ALL PATIENTS ARE TRANSFERRED TO THE INTENSIVE CARE UNIT POSTOPERATIVELY. THE REPORTED COMPLICATIONS INCLUDED BLEEDING WITHIN 48 HOURS POSTOPERATIVELY (N=1), CARDIAC TAMPONADE (N=2), LATE BLEEDING AT 1 WEEK POSTOPERATIVELY (N=1), ATRIOVENTRICULAR BLOCK (N=14), ENDOCARDITIS (=4), DEATH DUE TO CARDIAC-RELATED ISSUES WITHIN 30 DAYS (N=1), DEATH DUE TO CARDIAC-RELATED ISSUES OVER THE COURSE OF A YEAR (N=1), AND DEATH DUE TO CARDIAC-RELATED ISSUES DURING THE 3-YEAR FOLLOW-UP PERIOD (N=1). IN CONCLUSION, RETROSPECTIVE ANALYSIS OF OUR EARLY EXPERIENCE WITH TOTALLY ENDOSCOPIC AORTIC VALVE REPLACEMENT IN 266 CONSECUTIVE PATIENTS DEMONSTRATED SATISFACTORY RESULTS, WITH LOW MORTALITY AND ACCEPTABLE MORBIDITY RATES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    356602 PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE GAW ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death| R