BEUDAMED
    FDA Adverse Event Death Summary report: N

    MERSILENE POLYESTER FIBER SUTURE UNKNOWN PRODUCT

    MDR report key: 16120249 · Received January 9, 2023

    Report

    Report Number
    2210968-2023-00174
    Event Type
    Death
    Date Received
    January 9, 2023
    Date of Event
    August 21, 2021
    Report Date
    January 9, 2023
    Manufacturer
    ETHICON INC.
    Product Code
    GAT
    PMA / PMN Number
    K946173
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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. ARE THE REPORTS OF 30 DAY MORTALITY ASSOCIATED WITH MERSILENE SUTURE (0.35 MM; JOHNSON & JOHNSON)? WHAT WAS THE CAUSE OF DEATH? 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 MERSILENE SUTURES 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 2210968-2023-00175. CITATION: SCANDINAVIAN JOURNAL OF GASTROENTEROLOGY 2021, VOL. 56, NO. 11, 1376¿1379 HTTPS://DOI.ORG/10.1080/00365521.2021.1963836.

    Description of Event or Problem · 0

    TITLE: ENDOSCOPIC VACUUM ASSISTED CLOSURE (E-VAC) OF UPPER GASTROINTESTINAL LEAKAGES. PATIENTS TREATED WITH E-VAC BETWEEN 2012 AND 2019 AT A TERTIARY REFERRAL CENTER HAVE BEEN RETROSPECTIVELY ANALYZED. IN TOTAL, 116 PATIENTS WERE IDENTIFIED WHO WERE TREATED WITH E-VAC BETWEEN 2012 AND 2019. INDICATION FOR E-VAC. 116 PATIENTS TREATED WITH E-VAC WERE IDENTIFIED. INDICATION FOR E-VAC PLACEMENT WAS POSTOPERATIVE LEAKAGE. THE SPONGE WAS FIXED TO THE TIP OF THE DUODENAL TUBE WITH A MERSILENE SUTURE (0.35 MM; JOHNSON & JOHNSON REPORTED COMPLICATIONS INCLUDED E-VAC THERAPY FAILED (N=24), BLEEDING (N=4), E-VAC DISLOCATION AND DEVELOPMENT OF TRACHEOESOPHAGEAL FISTULA (N=5), DEVELOPMENT OF STENOSIS (N= 10), 30 DAYS IN HOSPITAL MORTALITY (N= 8). IN CONCLUSION E-VAC IS AN EMERGING HIGHLY EFFECTIVE INTERVENTIONAL ENDOSCOPIC TECHNIQUE FOR GASTROINTESTINAL WOUND CLOSURE EVEN IN HIGHLY SELECTED PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1563677 MERSILENE POLYESTER FIBER SUTURE UNKNOWN PRODUCT SUTURE, NONABSORBABLE, SYNTHETIC GAT ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention| D