BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ETHILON NYLON SUTURE UNKNOWN PRODUCT

    MDR report key: 17730334 · Received September 12, 2023

    Report

    Report Number
    2210968-2023-06610
    Event Type
    Injury
    Date Received
    September 12, 2023
    Date of Event
    December 14, 2021
    Report Date
    September 12, 2023
    Manufacturer
    ETHICON INC.
    Product Code
    GAR
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (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 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? 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. CITATION: J. CLIN. MED. 2021, 10, 5875. HTTPS://DOI.ORG/10.3390/JCM10245875.

    Description of Event or Problem · 0

    TITLE: TEACHING MICROSURGICAL BREAST RECONSTRUCTION ¿ A RETROSPECTIVE COHORT STUDY. THE OBJECTIVE OF THIS STUDY IS TO PRESENT AN APPROACH FOR TEACHING DEEP INFERIOR EPIGASTRIC ARTERY PERFORATOR (DIEP) AND TRANSVERSE UPPER GRACILIS (TUG) FLAP BREAST RECONSTRUCTION, WHICH CAN DIMINISH COMPLICATIONS AND PROVIDE SECURE AND SATISFYING OUTCOMES FROM THE FIRST BREAST RECONSTRUCTION WITH DIEP OR TMG FLAP, RESPECTIVELY. BETWEEN OCTOBER 2015 TO SEPTEMBER 2018, A TOTAL OF 95 DEEP INFERIOR EPIGASTRIC ARTERY PERFORATOR (DIEP) AND 93 TRANSVERSE UPPER GRACILIS (TUG) FLAPS WERE INCLUDED INTO THIS STUDY. BEFORE THE FIRST DIEP/TUG FLAP WITHOUT SUPERVISION, EACH TRAINEE UNDERWENT A MEAN OF 6.8 DIEP AND 7.3 TUG TRAINING SURGERIES. DIEP AND TUG FLAP PROCEDURES FOR BREAST RECONSTRUCTION WERE EITHER PERFORMED BY A SENIOR SURGEON (>200 DIEP/TUG, ¿NO-TRAINING GROUP¿), OR TAUGHT TO ONE OF FIVE TRAINEES (>80 BREAST SURGERIES; >50 FREE FLAPS) IN A STEP-WISE APPROACH. THE LATTER WERE EITHER PERFORMED BY THE SENIOR SURGEON, AND A TRAINEE WAS ASSISTING THE SURGERY (¿PASSIVE TRAINING¿); BY THE TRAINEE, AND A SENIOR SURGEON WAS SUPERVISING (¿ACTIVE TRAINING¿); OR BY THE TRAINEE WITHOUT A SENIOR SURGEON (¿AFTER TRAINING¿). SURGERIES OF EACH GROUP WERE ANALYZED REGARDING OR-TIME, COMPLICATIONS, AND REFINEMENT PROCEDURES. DURING SURGERY, MONO- AND BIPOLAR CAUTERY WERE USED, AND FOR PERFORATOR DISSECTION AND BRANCH LIGATURE, A LIGACLIP CLIP APPLIER WAS UTILIZED. ONCE THE FLAP WAS ELEVATED, THE SAME TEAM INSET THE FLAP AND PERFORMED THE ARTERIAL ANASTOMOSIS WITH INTERRUPTED SUTURES (8-0 ETHILON, ETHICON INC., SOMMERVILLE, NJ, USA). A COUPLER DEVICE (SYNOVIS MICRO COMPANIES ALLIANCE INC., BIRMINGHAM, AL, USA) WAS USED FOR VENOUS ANASTOMOSIS. REPORTED COMPLICATIONS INCLUDED REVISION (N=32), COMPLICATION TOTAL (N=139), PARTIAL FLAP LOSS (N=15), COMPLETE FLAP LOSS (N=7), FAT NECROSIS (N=25), WOUND DEHISCENCE RECIPIENT SITE (N=6), WOUND DEHISCENCE DONOR SITE (N=33), INFECTION RECIPIENT SITE (N=9), INFECTION DONOR SITE (N=16), HEMATOMA RECIPIENT SITE (N=26), HEMATOMA DONOR SITE (N=32), HERNIA DONOR SITE (N=3). IN CONCLUSION, THE INTRODUCED STEPWISE TRAINING APPROACH IS A SAFE AND EFFECTIVE METHOD FOR TEACHING MICROSURGICAL BREAST RECONSTRUCTION WITH MEANS OF DIEP AND TUG FLAPS. IMPORTANTLY, PRIOR TO STARTING MICROSURGICAL BREAST RECONSTRUCTION TRAINING, TRAINEES MUST BE CONFIDENT WITH GENERAL BREAST SURGERY AND MICROSURGERY. OF NOTE, NUMBER OF TRAINING PROCEDURES AND OUTCOMES DID NOT DIFFER BETWEEN PERFORATOR DIEP AND NON-PERFORATOR TUG FLAPS, HIGHLIGHTING THE IMPORTANCE OF TEACHING FLAP INSET AT THE RECIPIENT SITE FOR AN APPROPRIATE OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1173340 ETHILON NYLON SUTURE UNKNOWN PRODUCT SUTURE, NONABSORBABLE GAR ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention COUPLER DEVICE - SYNOVIS MICRO COMPANIES