BEUDAMED
    FDA Adverse Event Death Summary report: N

    VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

    MDR report key: 14935469 · Received July 6, 2022

    Report

    Report Number
    2210968-2022-05128
    Event Type
    Death
    Date Received
    July 6, 2022
    Date of Event
    September 8, 2021
    Report Date
    July 6, 2022
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K022269
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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. 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. COMPONENT CODE: (B)(4). THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. RELATED EVENTS CAPTURED VIA 2210968-2022-05129, 2210968-2022-05130, 2210968-2022-05132. CITATION: JOURNAL OF PEDIATRIC SURGERY 57 (2022) 41¿44, HTTPS://DOI.ORG/10.1016/J.JPEDSURG.2021.09.014.

    Description of Event or Problem · 0

    TITLE: EFFECT OF TRANSANASTOMOTIC FEEDING TUBES ON ANASTOMOTIC STRICTURES IN PATIENTS WITH ESOPHAGEAL ATRESIA AND TRACHEOESOPHAGEAL FISTULA: THE QUEBEC EXPERIENCE. THE PRIMARY OBJECTIVE OF THE STUDY WAS TO TEST THE HYPOTHESIS THAT TRANSANASTOMOTIC TUBES ARE ASSOCIATED WITH THE DEVELOPMENT OF ESOPHAGEAL STRICTURES FOLLOWING REPAIR OF ESOPHAGEAL ATRESIA WITH TRACHEOESOPHAGEAL FISTULA. THE SECONDARY OBJECTIVES WERE TO ASSESS THE EFFECT OF TRANSANASTOMOTIC TUBES ON THE DURATION OF POSTOPERATIVE (TOTAL PARENTERAL NUTRITION), TIME TO ENTERAL AND ORAL FEEDING, AND HOSPITAL STAY. A TOTAL OF 244 PATIENTS WITH TYPE C OR D ESOPHAGEAL ATRESIA WITH TRACHEOESOPHAGEAL FISTULA WHO UNDERWENT PRIMARY REPAIR WITHIN THE FIRST 6 MONTHS OF LIFE DURING A 25- YEAR PERIOD ((B)(6) 1993¿(B)(6) 2018) WERE INCLUDED IN THE STUDY. THERE WERE 133 MALES AND 111 FEMALES. THE MEDIAN GESTATIONAL AGE WAS 38 WEEKS (IQR 36¿40) AND MEAN BIRTH WEIGHT WAS 2700 ±703 GRAMS. OF THESE PATIENTS, A TOTAL OF 148 UTILIZED TRANSANASTOMOTIC TUBES. THE STANDARD TRANSANASTOMOTIC TUBE USED WAS A COMPETITOR¿S POLYURETHANE 6 FR TUBE PLACED INTRAOPERATIVELY, BEFORE COMPLETION OF THE ESOPHAGEAL ANASTOMOSIS WITH VICRYL SUTURE (ETHICON) OR PDS SUTURE (ETHICON). IF NO TRANSANASTOMOTIC TUBE WAS PLACED INTRAOPERATIVELY, THE PATIENT WAS KEPT NIL PER OS AND GIVEN TOTAL PARENTAL NUTRITION (TPN) UNTIL A CONTRAST ESOPHAGRAM WAS DONE USUALLY 5¿7 DAYS POSTOPERATIVELY. IF THERE WAS NO EVIDENCE OF A LEAK, ORAL FEEDING WITH BREAST MILK OR FORMULA WAS STARTED. IN THE TRANSANASTOMOTIC TUBES GROUP, ENTERAL FEEDING WAS STARTED USUALLY AFTER 48 H IF THE BABY WAS STABLE, PRIOR TO POSTOPERATIVE ESOPHAGOGRAM. THE REPORTED COMPLICATIONS INCLUDE ANASTOMOTIC LEAK (N=36), ANASTOMOTIC TENSION (N=66), RECURRENT TRANSESOPHAGEAL FISTULA (N=20), ESOPHAGEAL STRICTURES (N=72) AND DEATHS BEFORE DISCHARGE (N=4). IN CONCLUSION, TRANSANASTOMOTIC TUBES ARE ASSOCIATED WITH A SIGNIFICANTLY HIGHER RISK OF POSTOPERATIVE STRICTURE FOLLOWING REPAIR OF ESOPHAGEAL ATRESIA WITH TRACHEOESOPHAGEAL FISTULA AND DO NOT SHORTEN THE DURATION OF TOTAL PARENTERAL NUTRITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2058270 VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention| D