BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

    MDR report key: 7710605 · Received July 23, 2018

    Report

    Report Number
    2210968-2018-74549
    Event Type
    Injury
    Date Received
    July 23, 2018
    Report Date
    July 2, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K022269
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    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. CITATION: COLORECTAL DISEASE. 2009; 11: 821¿830. DOI: 10.1111/J.1463-1318.2008.01714.X (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE TITLE: STARR WITH CONTOUR_ TRANSTAR PROSPECTIVE MULTICENTRE EUROPEAN STUDY AUTHOR : L. LENISA, O. SCHWANDNER¿, A. STUTO, D. JAYNE, F. PIGOT, J.J. TUECH, R. SCHERER, K. NUGENT , F. CORBISIER , E. ESPIN-BASANY AND F. H. HETZER CITATION: COLORECTAL DISEASE. 2009; 11: 821¿830. DOI: 10.1111/J.1463-1318.2008.01714.X. THE STAPLED TRANSANAL RECTAL RESECTION (STARR) IN PATIENTS WITH DEFECATION DISORDERS IS LIMITED BY THE SHAPE AND CAPACITY OF THE CIRCULAR STAPLER. THE AIM OF THE STUDY WAS TO ASSESS THE FEASIBILITY OF THE CONTOUR TRANSTAR STAPLER AND TO RECORD FUNCTIONAL RESULTS UP TO 1 YEAR. FROM JANUARY TO JUNE 2007, A PROSPECTIVE EUROPEAN MULTICENTER STUDY OF 75 PATIENTS (MAJORITY ARE FEMALE PATIENTS [97%]; MEDIAN AGE: 64 YEARS; BMI: 17 TO 40) WITH DEFECATION DISORDER CAUSED BY INTERNAL RECTAL PROLAPSE UNDERWENT THE NEW STARR TECHNIQUE. DURING THE SURGICAL PROCEDURE, THE CONTOUR TRANSTAR-STR5G (ETHICON) STAPLING KIT WAS OPENED AND THE CIRCULAR ANAL DILATOR (CAD) GENTLY INTRODUCED AND FIXED TO THE PERIANAL SKIN WITH 4 CARDINAL SILK SUTURES. DURING THE PARACHUTE SUTURE PLACEMENT, AN INITIAL PROLENE 2-0 TRACTION SUTURE WAS PLACED AT THE 2 O¿CLOCK POSITION INTO THE APEX OF THE INTUSSUSCEPTION AND TWO OR THREE FURTHER FULL-THICKNESS BITES WERE TAKEN SO THAT THE NEEDLE EXITED AT THE 1 O¿CLOCK POSITION WHEN THE SUTURE WAS LOOSELY TIED. WORKING ANTICLOCKWISE, SIMILAR SUTURES WERE PLACED BETWEEN THE 12 AND 11 O¿CLOCK, 10 AND 9 O¿CLOCK, 8 AND 7 O¿CLOCK, 6 AND 5 O¿CLOCK AND 4 AND 3 O¿CLOCK POSITIONS, RESULTING IN SIX TRACTION SUTURES PLACED CIRCUMFERENTIALLY AROUND THE APEX OF THE INTUSSUSCEPTION, LEAVING A GAP BETWEEN 4 AND 2 O¿CLOCK FOR THE OPENING RADIAL STAPLE CUT. A 5TH TRACTION SUTURE WAS PLACED AT THE 3 O¿CLOCK POSITION AT THE POINT OF OPENING OF THE PROLAPSE, AND THIS WAS TIED TIGHTLY SUCH AS TO BE ABLE TO COLLAPSE THE TISSUE LIKE A CONCERTINA. A LOOP WAS MADE IN THE END OF THIS SUTURE THROUGH WHICH THE TRANSTAR STAPLER WAS PASSED INTO THE DISTAL RECTUM. TRACTION WAS APPLIED TO THE 3 O¿CLOCK SUTURE TO BRING THE PROLAPSE INTO THE JAWS OF THE STAPLER, AND THE STAPLER RETAINING PIN WAS THEN INSERTED AND THE STAPLER WAS CLOSED. THE STAPLER WAS FIRED RESULTING IN A RADIAL CUT INTO THE PROLAPSE, OPENING UP THE INTUSSUSCEPTION. A VICRYL MARKER SUTURE WAS PLACED AT THE APEX OF THE RADIAL CUT TO ACT AS A REFERENCE POINT FOR THE BEGINNING AND END OF THE CIRCUMFERENTIAL RESECTION AND TO PREVENT ¿SPIRALLING¿ OF THE STAPLE LINE. AFTER REPLACING THE STAPLER CARTRIDGE, THE DEVICE WAS RE-INTRODUCED INTO THE RECTUM AND ROTATED ANTICLOCKWISE WITH TRACTION ON THE 2 TO 12 O¿CLOCK AND 11 TO 9 O¿CLOCK SUTURES TO BRING THE REDUNDANT ANTERIOR PROLAPSE INTO THE JAWS OF THE STAPLER. THE RETAINING PIN AND THE STAPLER WERE CLOSED AND THE VAGINA CHECKED PRIOR TO FIRING THE STAPLER. THE FINAL STAPLE LINE WAS INSPECTED FOR BLEEDING WHICH WERE SECURED WITH INTERRUPTED VICRYL 3-0 SUTURES AS REQUIRED. REPORTED COMPLICATIONS INCLUDED PARTIAL DEHISCENCE OF THE STAPLE LINE (N-4) WHICH REQUIRED IMMEDIATE ADDITIONAL SUTURING (WITH NO FURTHER SURGICAL RE-INTERVENTION), SPIRAL RESECTION (N-3) WHICH REQUIRED CONSERVATIVE TREATMENT BY OBSERVATION AND ORAL ANTIBIOTIC MEDICATION, BUT NO FURTHER SURGICAL TREATMENT, GRADE IIIB BLEEDING (N-2) WHICH REQUIRED RE-OPERATION, AND GRADE IIIA BLEEDING (N-1) WHICH REQUIRED RECTOSCOPIC HEMOSTASIS. IT WAS REPORTED THAT THE CONTOUR TRANSTAR STAPLING KIT APPEARS TO BE AS SAFE AS THE PPH-STARR AND THE COMPLICATION RATE REPORTED IN THIS STUDY IS ACCEPTABLE. IT WAS CONCLUDED THAT THE CONTOUR TRANSTAR DEVICE APPEARS TO FACILITATE MORE TAILORED SURGERY, INCLUDING A REAL CIRCUMFERENTIAL FULL-THICKNESS RESECTION WITH THE POTENTIAL OF REMOVING MORE TISSUE. THIS MAY LEAD TO AN IMPROVED FUNCTIONAL OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    552044 VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention PROLENE SUTURE, STR56 STAPLER