BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT

    MDR report key: 18847774 · Received March 6, 2024

    Report

    Report Number
    2210968-2024-02517
    Event Type
    Injury
    Date Received
    March 6, 2024
    Date of Event
    May 30, 2023
    Report Date
    March 6, 2024
    Manufacturer
    ETHICON INC.
    Product Code
    GAW
    PMA / PMN Number
    K133356
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    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 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. COMPONENT CODE: G07002 ¿ DEVICE NOT RETURNED. THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. CITATION: FRONT. CARDIOVASC. MED. (2023); 10:1111496. HTTPS://DOI.ORG/10.3389/FCVM.2023.1111496.

    Description of Event or Problem · 0

    TITLE: ROBOTIC-ASSISTED MITRAL VALVE SURGERY WITHOUT AORTIC CROSS-CLAMPING: A SAFE AND FEASIBLE TECHNIQUE THE PRIMARY OBJECTIVE OF THIS STUDY WAS TO EVALUATE THE SAFETY AND FEASIBILITY OF ROBOTIC-ASSISTED MITRAL VALVE SURGERY WITHOUT AORTIC CROSS-CLAMPING. FROM (B)(6) 2010 TO (B)(6) 2022, A TOTAL OF 28 PATIENTS [16 MALE AND 12 FEMALE; MEAN AGE OF 71.5 ± 13.5 YEARS (RANGE 28¿92)] UNDERWENT ROBOTIC-ASSISTED MITRAL VALVE SURGERY WITHOUT AORTIC CROSS-CLAMPING USING DAVINCI ROBOTIC SYSTEMS. THE PATIENTS UNDERWENT EITHER MITRAL VALVE REPLACEMENT (N = 16, 57.1%) OR MITRAL VALVE REPAIR (N = 12, 42.9%). CONCOMITANT PROCEDURES WERE PERFORMED INCLUDING TRICUSPID VALVE REPAIR, TRICUSPID VALVE REPLACEMENT, PATENT FORAMEN OVALE (PFO) CLOSURE, LEFT ATRIAL APPENDAGE LIGATION, LEFT ATRIAL APPENDAGE THROMBECTOMY AND CRYOABLATION FOR ATRIAL FIBRILLATION. THE LA APPENDAGE WAS LIGATED IN PATIENTS WITH ATRIAL FIBRILLATION (AF) USING A DOUBLE-LAYERED RUNNING PROLENE 3.0 SUTURE FROM INSIDE THE LA. LEFT ATRIOTOMY IS CLOSED WITH TWO SEPARATE PROLENE SUTURES. REPORTED COMPLICATIONS INCLUDE BLEEDING (N=1) AND POSTOPERATIVE ATRIAL FIBRILLATION (N=6). IN CONCLUSION, ROBOTIC-ASSISTED MITRAL VALVE SURGERY WITHOUT CROSS-CLAMPING IS A SAFE AND FEASIBLE TECHNIQUE IN HIGH-RISK PATIENTS UNDERGOING REDO MITRAL SURGERY WITH SEVERE ADHESIONS AS WELL AS IN PRIMARY MITRAL VALVE CASES THAT ARE COMPLICATED WITH ASCENDING AORTIC CALCIFICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    110510 PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE GAW ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention