BEUDAMED
    FDA Adverse Event Death Summary report: N

    PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT

    MDR report key: 15041440 · Received July 18, 2022

    Report

    Report Number
    2210968-2022-05586
    Event Type
    Death
    Date Received
    July 18, 2022
    Date of Event
    July 26, 2021
    Report Date
    July 18, 2022
    Manufacturer
    ETHICON INC.
    Product Code
    NEW
    PMA / PMN Number
    N18331
    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? 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 2210968-2022-05583, 2210968-2022-05584, 2210968-2022-05585. CITATION CITE: CITATION: ORCID: HTTPS://ORCID.ORG/0000-0002-3122-0140.

    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). A RETROSPECTIVE COHORT ANALYSIS INVOLVING ALL HJS BETWEEN JANUARY 2014 AND DECEMBER 2018 WAS CONDUCTED. A TOTAL OF 556 ELIGIBLE PATIENTS WERE ANALYZED. POLYGLACTIN 3-0 AND 4-0(VICRYL), AND POLYDIOXANONE (PDS, 3-0, 4-0, 5-0 ) SUTURES WERE USED. REPORTED COMPLICATIONS INCLUDED CLAVIEN-DINDO (N=364), CLAVIEN-DINDO I (N=102) , CLAVIEN-DINDO II (N=14), CLAVIEN-DINDO IIIA (N=40), CLAVIEN-DINDO IIIB (N=19), CLAVIEN-DINDO IVA (N=1) , SEPTIC SHOCK AND DEATH (N=16) , BILE LEAK (N=54), SURGICAL SITE INFECTION, BILIARY FISTULA , INTRA-ABDOMINAL BLEEDING, ANASTOMOTIC STRICTURE. IN CONCLUSION LONG-TERM RESULTS, MORIBIDITY AND MORTALITY ASSOCIATED WITH CSHJ AND ISHJ ARE SIMILAR. HOWEVER, CSHJ IS MORE ECONOMICAL AND QUICKER, AND IS ASSOCIATED WITH A LOWER BILE LEAK RATE THAN ISHJ BASED ON THE ANALYSIS OF 556 HJS, AND THEREFORE MERITS ROUTINE USE IN SUITABLE DUCTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2892117 PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT SUTURE, SURGICAL, ABSORBABLE NEW ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention| D