BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

    MDR report key: 7307327 · Received March 1, 2018

    Report

    Report Number
    2210968-2018-71153
    Event Type
    Injury
    Date Received
    March 1, 2018
    Report Date
    February 12, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K022269
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) TO DATE THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. 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. WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. DOES THE SURGEON BELIEVE THAT VICRYL SUTURE INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS DESCRIBED IN THE ARTICLE? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH THE SUTURES USED IN THIS PROCEDURE? ARE THE PRODUCT CODE AVAILABLE FOR ETHICON DEVICES USED? CITATION: ANNALS OF PLASTIC SURGERY JUNE 2012; 68(6). DOI: 10.1097/SAP.0B013E318216B65C.

    Description of Event or Problem · 1

    TITLE: LATISSIMUS DORSI DONOR-SITE MORBIDITY: THE COMBINATION OF QUILTING AND FIBRIN SEALANT REDUCE LENGTH OF DRAIN PLACEMENT AND SEROMA RATE AUTHOR: STEVEN H. BAILEY, MD., GEORGETTE ONI, MBCHB, MRCS., RAFAEL GUEVARA, BSC., CORRINE WONG, MD., MICHEL SAINT-CYR, MD. CITATION: ANNALS OF PLASTIC SURGERY JUNE 2012; 68(6). DOI: 10.1097/SAP.0B013E318216B65C IT WAS REPORTED THAT THE SEROMA FORMATION HAS BEEN SHOWN TO BE A MULTIFACTORIAL PROCESS IN PART DUE TO DEAD SPACE AND THE FORMATION OF RAW SURFACES, WHICH PRODUCE LARGE QUANTITIES OF SEROUS EXUDATE. THE PURPOSE OF THIS STUDY IS TO EVALUATE THE USE OF QUILTING OR PROGRESSIVE TENSION SUTURES AND FIBRIN SEALANT IN TANDEM AS AN ADJUNCT TO DECREASE SEROMA RATE AND DURATION OF DRAIN PLACEMENT IN PATIENTS UNDERGOING A LATISSIMUS DORSI-BASED (LD) BREAST RECONSTRUCTION. A RETROSPECTIVE REVIEW OF 42 PATIENTS WERE INCLUDED IN THIS STUDY. THE CONTROL GROUP (QUILTING GROUP; VICRYL 2-0 SUTURE) CONSISTS OF 19 PATIENTS AND THE TREATMENT GROUP (QUILTING AND SEALANT GROUP; VICRYL 2-0 SUTURES AND EVICEL FIBRIN SEALANT) CONSISTS OF 23 PATIENTS. AFTER THE LATISSIMUS FLAP WAS HARVESTED AND HEMOSTASIS WAS ACHIEVED, THE DONOR SITE WILL BE CLOSED USING THE QUILTING TECHNIQUE. THE SUTURES WERE PLACED IN HORIZONTAL ROWS, AROUND 5-CM APART USING VICRYL 2-0 SUTURE PLACED IN THE SUBCUTANEOUS SKIN FLAP AND THEN THROUGH THE FASCIA OF THE UNDERLYING POSTERIOR-LATERAL CHEST WALL. PATIENTS WHO HAD FIBRIN SEALANT HAD QUILTING SUTURES AS DESCRIBED ABOVE. CARE WAS TAKEN TO SPACE THE ROWS APPROPRIATELY TO PROVIDE FOR CLOSURE OF THE DEAD SPACE AND EASY APPLICATION OF THE FIBRIN SEALANT. FIVE MILLILITERS OF THE EVICEL FIBRIN SEALANT WAS THEN ADDED USING THE PROVIDED APPLICATOR. IT WAS REPORTED THAT 1 PATIENT IN THE QUILTING GROUP DEVELOPED SEROMA (5%) AND WAS TREATED AND RESOLVED WITH ASPIRATION. THE QUILTING AND SEALANT GROUP HAD A SIMILAR SEROMA RATE OF 4 % (TREATMENT FOR THE EVENT WAS NOT REPORTED). IT WAS CONCLUDED THAT THE SEROMA FORMATION AT THE LD FLAP DONOR SITE CAN BE THE CAUSE OF MORBIDITY FOR PATIENTS. THIS STUDY SHOWS THAT THE COMBINATION OF 2 INDEPENDENTLY VALIDATED METHODS (QUILTING AND FIBRIN SEALANT) CAN SIGNIFICANTLY DECREASE THE LENGTH OF POST OPERATIVE DRAINAGE AND ALSO REDUCE THE SEROMA RATES WHEN COMPARED WITH QUILTING SUTURES ALONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    149329 VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention