BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

    MDR report key: 8870784 · Received August 7, 2019

    Report

    Report Number
    2210968-2019-85273
    Event Type
    Injury
    Date Received
    August 7, 2019
    Report Date
    July 11, 2019
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K022269
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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. 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 ETHICON PRODUCTS (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 ETHICON PRODUCTS (VICRYL SUTURE) USED IN THIS PROCEDURE? PATIENT DEMOGRAPHICS. CITATION: UPDATES SURG. 2014; 66: 151¿156. DOI: 10.1007/S13304-014-0247-2. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: "TITLE: SHORT-TERM RESULTS AFTER STARR VERSUS INTERNAL DELORME FOR OBSTRUCTED DEFECATION: A NON-RANDOMIZED PROSPECTIVE STUDY" AUTHORS: N. L. OHAZURUIKE, J. MARTELLUCCI, C. MENCONI, S. PANICUCCI, G. TONIOLO, G. NALDINI CITATION: UPDATES SURG. 2014; 66: 151¿156. DOI: 10.1007/S13304-014-0247-2. OBSTRUCTED DEFECATION SYNDROME DUE TO INTERNAL INTUSSUSCEPTION AND RECTOCELE IS A COMMON DISEASE, AND VARIOUS TRANSANAL SURGICAL TECHNIQUES HAVE BEEN PROPOSED. THE AIM OF THE STUDY WAS TO COMPARE THE INTERNAL DELORME (ID) AND THE STAPLED TRANSANAL RECTAL RESECTION (STARR) RESULTS IN THE TREATMENT OF PATIENTS WITH OBSTRUCTED DEFECATION SYNDROME. FROM SEPTEMBER 2011 TO MAY 2012, A TOTAL OF 23 PATIENTS (19 FEMALE AND 4 MALE PATIENTS; MEDIAN AGE: 52.6 YEARS) WERE OPERATED WITH STARR PROCEDURE AND 12 PATIENTS (8 FEMALE AND 4 MALE PATIENTS; MEDIAN AGE: 58.4 YEARS) WITH DELORME¿S PROCEDURE FOR OBSTRUCTED DEFECATION SYNDROME. DURING THE STARR PROCEDURE, PPH-01 STAPLERS (ETHICON) WERE USED. DURING THE DELORME¿S PROCEDURE, VERTICAL PLICATION OF VICRYL 2¿0 SUTURE STITCHES (ETHICON) WERE THEN PLACED IN THE MUSCLE, STARTING AT THE PROXIMAL EXTENT OF THE MUCOSECTOMY, DIVIDING THE ANAL CIRCUMFERENCE INTO 4 QUADRANTS. SUTURES ENDED AT THE DISTAL EDGE OF THE MUCOSA ABOVE THE DENTATE LINE. EXCESS MUCOSA WAS AMPUTATED, AND A MUCOSAL ANASTOMOSIS WAS COMPLETED WITH VICRYL 2-0 (ETHICON). IN THE STARR GROUP, REPORTED COMPLICATIONS INCLUDED TRANSIENT INCONTINENCE TO FLATUS (N-2) WHICH SPONTANEOUSLY RESOLVED IN THE FIRST MONTH, INCONTINENCE TO LIQUID AND FLATUS (N-2) WHICH RESOLVED AFTER 6 MONTHS, INCONTINENCE TO LIQUID STOOLS (N-1) WHICH RESOLVED AFTER 6 MONTHS, URGE TO DEFECATE (N-14) WITH IMPROVEMENT OF THE SYMPTOMS AFTER 3 MONTHS IN 5 PATIENTS AND PERSISTING SYMPTOMS IN 1 PATIENT, RECTAL STENOSIS (N-1), BLEEDING (N-1), FECALOMA (N-2), BLEEDING DUE TO FECAL IMPACTION (N-1), FECAL IMPACTION (N-1). IN THE DELORME¿S GROUP, REPORTED COMPLICATIONS INCLUDED TRANSIENT INCONTINENCE TO FLATUS (N-2) WITH RELIEF OF THE SYMPTOMS IN THE FURTHER EXAMINATIONS, TRANSIENT INCONTINENCE TO LIQUID AND FLATUS (N-3) WITH RELIEF OF SYMPTOMS AFTER 3 AND 6TH MONTH, URGE TO DEFECATE (N-8) WITH AN IMPROVEMENT WITHIN 3 MONTHS IN FIVE PATIENTS AND PERSISTING SYMPTOMS AFTER 6 MONTHS ONLY IN ONE PATIENT WHO UNDERWENT BIOFEEDBACK THERAPY, INFLAMMATORY RECTAL STENOSIS (N-1) AND WAS TREATED WITH TOPIC BECLOMETHASONE DIPROPIONATE 3 MG AND MESALAZINE 400 MG, RECTAL STENOSIS (N-1), AND FECALOMA (N-1) AND WAS TREATED WITH ENEMAS. IN THE EXPERIENCE, THE SURGICAL TREATMENT OF OBSTRUCTED DEFECATION SYNDROME BY TRANSANAL APPROACH WITH INTERNAL DELORME OR STARR PROCEDURE SEEM TO BE SATISFACTORY, WITH COMPARABLE SHORT-TERM RESULT. MOREOVER, ALSO THE SUBJECTIVE SATISFACTION RATE OF THE TWO GROUPS OF PATIENTS WAS HIGH. INTERNAL DELORME SHOULD BE CONSIDERED FOR PATIENTS WITH HIGH RISK OF POSTOPERATIVE CONTINENCE ALTERATION. DESPITE THE SHORT FOLLOW-UP PERIOD, BOTH THE RESULTS AND THE COMPLICATIONS RATE SEEM TO BE GOOD IF THE PATIENTS ARE WELL SELECTED AND OPERATED ON BY EXPERIENCED COLORECTAL SURGEONS. FURTHER STUDIES ARE REQUIRED WITH LARGER NUMBER OF PATIENTS AND LONGER FOLLOW-UP TO EVALUATE THE RECURRENCE RATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    663793 VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention