BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ETHIBOND EXTRA & EXCEL POLYESTER SUTURE UNKNOWN

    MDR report key: 12439134 · Received September 8, 2021

    Report

    Report Number
    2210968-2021-08124
    Event Type
    Injury
    Date Received
    September 8, 2021
    Date of Event
    February 18, 2020
    Report Date
    August 25, 2021
    Manufacturer
    ETHICON INC.
    Product Code
    GAT
    PMA / PMN Number
    K946173
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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? 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. (B)(4). THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. CITATION: GENERAL THORACIC AND CARDIOVASCULAR SURGERY (2020); 68,1079¿1085. DOI: HTTPS://DOI.ORG/10.1007/S11748-020-01317-2.

    Description of Event or Problem · 1

    TITLE: EARLY RESULTS OF ROBOTICALLY ASSISTED MITRAL VALVE REPAIR IN A SINGLE INSTITUTION: REPORT OF THE FIRST 100 CASES. THE AIM OF THIS RETROSPECTIVE STUDY IS TO ASSESS THE SAFETY AND CLINICAL OUTCOMES OF ROBOTIC MITRAL VALVE SURGERY IN THE FIRST 100 CASES PERFORMED IN OUR CENTER. BETWEEN APRIL 2018 TO AUGUST 2019, A TOTAL OF 100 PATIENTS WHO UNDERWENT ROBOTIC PRIMARY MITRAL VALVE REPAIR, INCLUDING CONCOMITANT PROCEDURES, WERE INCLUDED IN THE STUDY. THE CAUSE OF MITRAL VALVE DISEASE WAS DEGENERATIVE (N = 94), ENDOCARDITIS (N = 2), FUNCTIONAL (N = 2), AND OTHER (N = 2). ALL PATIENTS RECEIVED ANNULOPLASTY WITH A PROSTHETIC FULL RING OR PARTIAL BAND WITH 2-0 ETHIBOND CONTINUOUS SUTURES (JOHNSON AND JOHNSON, SOMERVILLE, NJ, USA). REPORTED COMPLICATIONS INCLUDED HEMOLYTIC ANEMIA RELATED TO RECURRENT GRADE 3 MITRAL VALVE REGURGITATION (N=2) WHICH REQUIRED IN-HOSPITAL SURGICAL RE-INTERVENTION OF THE MITRAL VALVE; GRADE 2 MR (N=4); ACUTE INFECTIVE ENDOCARDITIS (N=1); AND UNKNOWN EVENT (N=34) REQUIRING BLOOD TRANSFUSION. IN CONCLUSION, ROBOTICALLY ASSISTED MITRAL VALVE REPAIR WAS FEASIBLE, SAFE, AND THERAPEUTICALLY EFFECTIVE IN THE FIRST 100 CASES, WITH A MINIMAL LEARNING CURVE. THE ROBOTICALLY ASSISTED APPROACH PROVIDES A HIGH-QUALITY SURGICAL VIEW AND TREMORLESS SUTURE/CUT HANDLING, WHICH WILL CONTRIBUTE TO FURTHER DEVELOPMENT OF MINIMALLY INVASIVE MITRAL VALVE SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1339086 ETHIBOND EXTRA & EXCEL POLYESTER SUTURE UNKNOWN SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE GAT ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention