BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT

    MDR report key: 7658881 · Received July 3, 2018

    Report

    Report Number
    2210968-2018-74032
    Event Type
    Injury
    Date Received
    July 3, 2018
    Report Date
    June 8, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    GAW
    PMA / PMN Number
    K133356
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    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. DOES THE SURGEON BELIEVE THAT THE ETHICON PRODUCTS INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POSTOPERATIVE COMPLICATIONS DESCRIBED IN THE ARTICLE? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH THE ETHICON SUTURE PRODUCTS USED IN THIS PROCEDURE? CITATION: ASIAN JOURNAL OF ANDROLOGY. 2016 18, 129¿133. DOI: 10.4103/1008-682X.159718. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: "TITLE : MULTIPLE FACTORS AFFECTING SURGICAL OUTCOMES AND PATENCY RATES IN USE OF SINGLE-ARMED TWO-SUTURE MICROSURGICAL VASOEPIDIDYMOSTOMY: A SINGLE SURGEON¿S EXPERIENCE WITH 81 PATIENTS". AUTHOR : KAI HONG1,2,3, LIAN-MING ZHAO1, SHI-XING XU1, WEN-HAO TANG1, JIA-MING MAO2, DE-FENG LIU2, HUI JIANG, LU-LIN MA1, JIE QIAO. CITATION: ASIAN JOURNAL OF ANDROLOGY. 2016 18, 129¿133. DOI: 10.4103/1008-682X.159718. VASOEPIDIDYMOSTOMY (VE), AS THE MOST CHALLENGING PROCEDURE IN MICROSURGERIES, IS OFTEN CARRIED OUT WITH A DOUBLE-ARMED TWO-SUTURE TECHNIQUE. IN THIS STUDY, THE AUTHORS EVALUATED THE EFFICACY AND SAFETY OF THE SINGLE-ARMED TWO-SUTURE VES ON HUMANS AND STUDIED THE FACTORS THAT COULD POSSIBLY AFFECT THE PATENCY RATES. FROM JULY 2012 TO JULY 2013, THE AUTHORS REVIEWED A TOTAL OF 61 PATIENTS (ALL MALE PATIENTS; MEAN AGE OF PATIENTS WAS 31 YEARS [23 TO 45 YEARS OLD]) WITH CONSECUTIVE EPIDIDYMAL OBSTRUCTION AZOOSPERMIA PATIENTS, WHO UNDERWENT MICROSURGICAL VE WITH SINGLE-ARMED TWO-SUTURE TECHNIQUE, WERE ENROLLED IN THE STUDY. DURING THE PROCEDURE, TO REDUCE THE TENSION FOR NEXT ANASTOMOSIS, THE VAS DEFERENS WAS SUTURED TO THE EDGE OF THE EPIDIDYMAL TUNIC WITH ONE PROLENE 8-0 SUTURE STITCH AT THE 6 O¿CLOCK POSITION OF THE VAS. TWO SINGLE-ARMED PROLENE 9-0 OR PROLENE 10-0 SUTURES WERE USED TO PERFORM LONGITUDINAL INTUSSUSCEPTION. DUE TO DIFFICULTIES IN ACCESSING APPROPRIATE MICROSURGICAL SUTURES, WE INITIALLY USED PROLENE 9-0 SUTURES FOR VES BEFORE PROLENE 10-0 SUTURES BECAME COMMERCIALLY AVAILABLE IN OUR HOSPITAL. BEFORE THE 2 SUTURES WERE TIED TOGETHER, A PROLENE 8-0 WAS SUTURED TO THE VAS AT THE 12 O'CLOCK POSITION AND TO THE EPIDIDYMAL TUNIC IN ORDER TO RELEASE THE TENSION. AFTER THE 2 PROLENE 10-0 SUTURES WERE TIED DOWN, THE EPIDIDYMAL TUBULES WERE INTUSSUSCEPTED INTO THE LUMEN OF THE VAS DEFERENS. THE ANASTOMOSIS WAS THEN SUPPORTED BY AN OUTER LAYER OF 14 STITCHES WITH PROLENE 8-0 SUTURES AS A STANDARD PROCEDURE. REPORTED COMPLICATIONS INCLUDED MILD HEMATOMA (N-1) WHICH REQUIRED CONSERVATIVE TREATMENT AND EPIDIDYMITIS ALONG WITH FAILURE IN PATENCY (N-1) WHICH REQUIRED TREATMENT WITH ANTIBIOTICS AND RECOVERED AFTERWARDS. IT WAS CONCLUDED THAT THE SINGLE-ARMED SUTURE TECHNIQUE FOR VES IS A COST-EFFECTIVE OPTION, AND ITS PATENCY AND PREGNANCY RATES ARE COMPARABLE TO THE DOUBLED-ARMED VASOEPIDIDYMOSTOMY TECHNIQUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    500683 PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT SUTURE, NONABSORBABLE GAW ETHICON INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention