BEUDAMED
    FDA Adverse Event Death Summary report: N

    VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

    MDR report key: 15654767 · Received October 21, 2022

    Report

    Report Number
    2210968-2022-08649
    Event Type
    Death
    Date Received
    October 21, 2022
    Date of Event
    July 26, 2021
    Report Date
    October 21, 2022
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K022269
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    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. (B)(4). THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. RELATED EVENTS CAPTURED VIA: 2210968-2022-08650, 2210968-2022-08651, 2210968-2022-08652. CITATION: ANN HEPATOBILIARY PANCREAT SURG 2021;25:472-476. HTTPS://DOI.ORG/10.14701/AHBPS.2021.25.4.472.

    Description of Event or Problem · 0

    TITLE: ECONOMICS AND SAFETY OF CONTINUOUS AND INTERRUPTED SUTURE HEPATICOJEJUNOSTOMY: AN AUDIT OF 556 SURGERIES. THIS STUDY COMPARES THE SAFETY, ECONOMICS, SHORT- AND LONG-TERM OUTCOMES OF CONTINUOUS SUTURE HEPATICOJEJUNOSTOMY (CSHJ) AND INTERRUPTED SUTURE HEPATICOJEJUNOSTOMY (ISHJ). RETROSPECTIVE COHORT ANALYSIS INVOLVING ALL HJS BETWEEN JANUARY 2014 AND DECEMBER 2018 WAS CONDUCTED. A TOTAL OF 556 ELIGIBLE PATIENTS (468 PATIENTS UNDERGOING ISHJ AND 88 UNDERGOING CSHJ; [N = 261] WITH MALIGNANT AND [N = 295] WITH BENIGN PATHOLOGY) WERE ANALYZED. POLYGLACTIN 3-0 AND 4-0 (VICRYL) AND POLYDIOXANONE (PDS) 3-0, 4-0, AND 5-0 SUTURES (ETHICON, AURANGABAD, INDIA) WERE USED FOR HJ. THE PATIENTS WERE FOLLOWED UP AT REGULAR INTERVALS POST-OPERATIVELY (INITIALLY AT 3 MONTHS, 6 MONTHS AND THEN YEARLY) WITH ABDOMINAL SONOGRAPHY AND LIVER FUNCTION TESTS. SIXTEEN PATIENTS SHOWED 30-DAY MORTALITY FOLLOWING SURGERY DUE TO SEPSIS, CSHJ: (N=6) BILE LEAK. (N=10) GRADE IIIA MORBIDITY. (N=3) GRADE IIIB MORBIDITY. (N=3) REQUIRED PCD INSERTION. (N=?) UNDERWENT SINGLE-TIME ASPIRATION. (N=?) SSI REQUIRING DELAYED SKIN SUTURING. ISHJ: (N=48) BILE LEAK. (N=30) GRADE IIIA MORBIDITY. (N=16) GRADE IIIB MORBIDITY. (N=13) REQUIRED PCD INSERTION. (N=?) UNDERWENT SINGLE-TIME ASPIRATION. (N=?) SSI REQUIRING DELAYED SKIN SUTURING. (N=2) RE-EXPLORATION FOR BILE LEAK. -1 REINFORCING SUTURES AT HJ SITE. -1 MANAGED WITH LAVAGE AND DRAINAGE TO CREATE A CONTROLLED EXTERNAL BILIARY FISTULA (N=1) RECOVERED FOLLOWING TO INTENSIVE CARE UNIT SUPPORT FOR MANAGING SEPSIS AND ORGAN FAILURE (GRADE IV). IN CONCLUSION, CSHJ IS A SAFE, ECONOMICAL, AND WORTHY OF ROUTINE USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1647433 VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention| D