BEUDAMED
    FDA Adverse Event Death Summary report: N

    VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

    MDR report key: 17197229 · Received June 26, 2023

    Report

    Report Number
    2210968-2023-04584
    Event Type
    Death
    Date Received
    June 26, 2023
    Date of Event
    July 19, 2022
    Report Date
    June 23, 2023
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K022269
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    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. H6 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 2210968-2023-04583, 2210968-2023-04584, 2210968-2023-04585, 2210968-2023-04586, 2210968-2023-04587. CITATION: SURGICAL ENDOSCOPY(B)(6). HTTPS://DOI.ORG/10.1007/S00464-022-09415-3.

    Description of Event or Problem · 0

    TITLE: CONTINUOUSLY SUTURED VERSUS LINEAR-STAPLED ANASTOMOSIS IN ROBOT-ASSISTED HYBRID IVOR LEWIS ESOPHAGEAL SURGERY FOLLOWING NEOADJUVANT CHEMORADIOTHERAPY: A SINGLE-CENTER COHORT STUDY. THE AIM OF THIS STUDY WAS TO ANALYZE PERIOPERATIVE MORBIDITIES AND SHORT-TERM OUTCOMES IN PATIENTS UNDERGOING HYBRID ROBOT-ASSISTED ESOPHAGEAL SURGERY FOLLOWING NEOADJUVANT CHEMORADIOTHERAPY (NCRT), WITH COSU OR LIST ANASTOMOSES IN A SINGLE CENTER. FOLLOWING STANDARDIZED, EFFECTIVE, NCRT, 53 PATIENTS UNDERWENT A HYBRID IVOR LEWIS ROBOT-ASSISTED ESOPHAGECTOMY WITH COSU (N = 32) OR LIST (N = 21) GASTROESOPHAGEAL ANASTOMOSES. THE STAPLE LINE WAS THEN FURTHER SECURED WITH MULTIPLE STITCHES WITH MONOCRYL. IN LIST TECHNIQUE THE ANTERIOR WALL OF THE ANASTOMOSIS WAS SUTURED WITH TWO STRATAFIX 3.0 CONTINUOUS SUTURES AND AN ADDITIONAL LAYER OF SINGLE 3.0 VICRYL STITCHES. THE END-TO-SIDE ESOPHAGOGASTROSTOMY BY COSU TECHNIQUE WAS PERFORMED USING A CONTINUOUS STRATAFIX 3.0 BIDIRECTIONAL SPIRAL KNOTLESS SUTURE. BEFORE STARTING THE RUNNING SUTURE FROM THE POSTERIOR WALL TOWARD BOTH SIDES OF THE ANTERIOR PART, TWO VICRYL 3.0 STAY SUTURES WERE PLACED TO HOLD THE LUMEN WIDE OPEN. ADDITIONAL VICRYL 4.0 SINGLE STICHES WERE CAREFULLY PLACED FOR FURTHER ADAPTATION WITHOUT COMPROMISING PERFUSION. COMPLETION OF THE CIRCULAR ANASTOMOSIS, THE TWO ENDS OF THE CONTINUOUS SUTURES WERE KNOTTED AND THE ANASTOMOSIS WAS SECURED WITH A SECOND LAYER OF 3.0 VICRYL INTERRUPTED SUTURES. AN OMENTAL PATCH WAS PLACED OVER THE ANASTOMOSIS AND ATTACHED TO THE PLEURA WITH THREE VICRYL 3.0 SUTURES IN BOTH TECHNIQUES. REPORTED COMPLICATIONS INCLUDED COSU GROUP: ANASTOMOTIC LEAKAGE (N=3), PLEURAL EMPYEMA (N=1), MORTALITY (N=1) , DYSPHAGIA (N=4), DYPNEA (N=1)- , ANASTOMOTIC STENOSIS (N=1), DELAYED WOUND HEALING. LIST GROUP: ANASTOMOTIC LEAKAGE (N=2), PLEURAL EMPYEMA (N=2), MORTALITY DUE TO SEVERE SEPSIS (N=1), DYSPHAGIA (N=1), NECROSIS IN CONCLUSION COSU IS NOT INFERIOR TO LIST IN THE PERFORMANCE OF GASTROESOPHAGEAL ANASTOMOSIS IN HYBRID IVOR LEWIS OPERATIONS FOLLOWING NCRT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1647173 VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention| D