BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT

    MDR report key: 10784529 · Received November 4, 2020

    Report

    Report Number
    2210968-2020-08648
    Event Type
    Injury
    Date Received
    November 4, 2020
    Date of Event
    January 2, 2019
    Report Date
    October 12, 2020
    Manufacturer
    ETHICON INC.
    Product Code
    GAW
    PMA / PMN Number
    K133356
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    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 ADDITIONAL INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT THE LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. DOES THE AUTHOR/SURGEON BELIEVE THAT ETHICON PRODUCTS (PROLENE SUTURE) INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS DESCRIBED IN THE ARTICLE? DOES THE AUTHOR/SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH THE ETHICON PRODUCTS (PROLENE SUTURE) USED IN THIS PROCEDURE? WERE THESE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. PLEASE PROVIDE PATIENT DEMOGRAPHICS: FOR THE PATIENTS IN TABLE 1, FOR PATIENTS 1 THROUGH IX, PLEASE PROVIDE THE PATIENT DEMOGRAPHICS FROM TABLE 4 THAT ALIGN WITH THE PATIENTS IN TABLE 1. FOR THE PATIENTS IN TABLE 2, FOR PATIENTS 1 THROUGH VIII, PLEASE PROVIDE THE PATIENT DEMOGRAPHICS FROM TABLE 4 THAT ALIGN WITH THE PATIENTS IN TABLE 2. CITATION: TECHNIQUES IN COLOPROCTOLOGY (2019) 23:43¿52. DOI: HTTPS://DOI.ORG/10.1007/S10151-018-1918-7. EVENTS FOR PATIENTS WITH PERSISTENCE WERE SUBMITTED VIA 2210968-2020-08642, 2210968-2020-08643, 2210968-2020-08645, 2210968-2020-08646, 2210968-2020-08647, AND 2210968-2020-08649. ALSO, EVENTS WERE SUBMITTED VIA 2210968-2020-08621 FOR UNIDENTIFIED PATIENTS, AND PATIENTS WITH RECURRENCE: 2210968-2020-08622, 2210968-2020-08623, 2210968-2020-08624, 2210968-2020-08626, 2210968-2020-08627, 2210968-2020-08628, 2210968-2020-08629, 2210968-2020-08630 AND 2210968-2020-08631.

    Description of Event or Problem · 1

    FILE (B)(4) RAISED FROM (B)(4): TITLE: GRACILIS MUSCLE TRANSPOSITION FOR TREATMENT OF RECURRENT ANOVAGINAL, RECTOVAGINAL, RECTOURETHRAL, AND POUCH¿VAGINAL FISTULAS IN PATIENTS WITH INFLAMMATORY BOWEL DISEASE. AUTHORS: S. KORSUN · G. LIEBIG-HOERL · A. FUERST. CITATION: TECHNIQUES IN COLOPROCTOLOGY (2019) 23:43¿52. DOI: HTTPS://DOI.ORG/10.1007/S10151-018-1918-7. THE AIM OF THIS STUDY WAS TO EVALUATE THE EFFECTIVENESS OF GRACILIS MUSCLE TRANSPOSITION (GMT) TO TREAT RECURRENT ANOVAGINAL, RECTOVAGINAL, RECTOURETHRAL, AND POUCH¿VAGINAL FISTULAS IN PATIENTS WITH INFLAMMATORY BOWEL DISEASE (IBD). THIS RETROSPECTIVE STUDY INVOLVES 32 PATIENTS (2 MALE AND 30 FEMALE; MEAN AGE: 39 YEARS; AGE RANGE: 24¿55 YEARS) WITH IBD WHO UNDERWENT GRACILIS TRANSPOSITION OR RE-TRANSPOSITION FOR A RECURRENT FISTULA BETWEEN JANUARY 2000 AND MARCH 2018 AND ATTENDED AT LEAST THE FIRST FOLLOW-UP VISIT AT 3 MONTHS. DURING THE PROCEDURE, THE DISTAL TENDON OF THE MUSCLE WAS FIXED WITH PROLENE SUTURES (ETHICON, BRIDGEWATER, NJ AND CINCINNATI, OH, USA) TO THE CONTRALATERAL PUBIC OR ISCHIAL PERIOSTEUM AFTER TRANSPOSITION THROUGH AN ADDITIONAL SUBCUTANEOUS TUNNEL AND A SMALL INCISION ON THIS SIDE. IF THE MEDICAL HISTORY OF THE PATIENT INDICATED FECAL INCONTINENCE, THE DISTAL MUSCLE TENDON WAS TRANSPOSED FURTHER TO ENCIRCLE THE ANAL CANAL, AND FIXED AT THE IPSILATERAL PUBIC OR ISCHIAL PERIOSTEUM, THUS CREATING A LOOP (GAMMA-LOOP) REPORTED COMPLICATIONS INCLUDED WOUND INFECTION WITH ISCHEMIA OF THE GRACILIS MUSCLE (N-1), SUTURE GRANULOMA (N-2) AND LYMPHOEDEMA (N-1). ADDITIONAL PROCEDURES AFTER GMT FOR PATIENTS WITH RECURRENCE: PATIENT I WHO UNDERWENT GMT ON (B)(6) 2002 HAD A RECURRENCE AND UNDERWENT ABSCESS EXCISION, 2 FISTULECTOMIES AND DOUBLE BARRELL ILEOSTOMY. AT LAST FOLLOW UP, FISTULA WAS NOT CLOSED. PATIENT II WHO UNDERWENT GMT ON (B)(6) 2005 HAD A RECURRENCE/NEW FISTULA AND UNDERWENT 3 FISTULECTOMIES, RECTAL MUSCLE FLAP, FISTULA PLUG, VAGINAL ADVANCEMENT FLAP, LOOP SIGMOIDOSTOMY, VAGINAL FLAP AND STOMA CLOSURE. AT LAST FOLLOW UP, FISTULA WAS CLOSED. PATIENT III WHO UNDERWENT GMT ON (B)(6) 2013 HAD A RECURRENCE AND UNDERWENT BIOMESH PROCEDURE, 2 SETON PROCEDURES AND VAGINAL FLAP. AT LAST FOLLOW UP, FISTULA WAS NOT CLOSED. PATIENT IV WHO UNDERWENT GMT ON (B)(6) 2009 HAD A RECURRENCE AFTER CROHN RELAPSE AND UNDERWENT 6 RECTAL FLAPS, 2 FISTULECTOMIES, A DOUBLE BARREL COLOSTOMY, VAGINAL FLAP AND MARTIUS FLAP. AT LAST FOLLOW UP, FISTULA WAS NOT CLOSED PATIENT V WHO UNDERWENT GMT ON (B)(6) 2015 HAD A RECURRENCE AND UNDERWENT STOMA CLOSURE, ABSCESS EXCISION AND FISTULECTOMY. AT LAST FOLLOW UP, FISTULA WAS CLOSED. PATIENT VI WHO UNDERWENT GMT ON (B)(6) 2016 HAD RECURRENCE AND UNDERWENT STOMA CLOSURE AND FISTULECTOMY. AT LAST FOLLOW UP, FISTULA WAS CLOSED. PATIENT VII WHO UNDERWENT GMT ON (B)(6) 2005 HAD RECURRENCE AND UNDERWENT ABSCESS EXCISION, SETON AND DOUBLE BARREL ILEOSTOMY. AT LAST FOLLOW UP, HOUSE BAN WAS REPORTED AND FISTULA WAS NOT CLOSED. PATIENT VIII WHO UNDERWENT GMT ON (B)(6) 2016 HAD RECURRENCE AND UNDERWENT 2 ABSCESS EXCISIONS, FISTULECTOMY, RECTAL FLAP AND STOMA CLOSURE. AT LAST FOLLOW UP, FISTULA WAS CLOSED. PATIENT IX WHO UNDERWENT GMT ON (B)(6) 2006 HAD RECURRENCE AND UNDERWENT FISTULECTOMY AND RECTAL ADVANCEMENT FLAP. AT LAST FOLLOW UP, FISTULA WAS CLOSED. ADDITIONAL PROCEDURES AFTER GMT FOR PATIENTS WITH FISTULA PERSISTENCE: PATIENT I WHO UNDERWENT GMT ON (B)(6) 2016 HAD A FISTULA PERSISTENCE UNDERWENT 3 FISTULECTOMIES AND 2 RECTAL FLAPS. AT LAST FOLLOW UP, FISTULA WAS NOT CLOSED. PATIENT II WHO UNDERWENT GMT ON (B)(6) 2014 HAD A FISTULA PERSISTENCE UNDERWENT RECTAL FLAP AND STOMA CLOSURE. AT LAST FOLLOW UP, FISTULA WAS CLOSED PATIENT III WHO UNDERWENT GMT ON (B)(6) 2015 HAD A FISTULA PERSISTENCE UNDERWENT RECTAL FLAP AND STOMA CLOSURE. AT LAST FOLLOW UP, FISTULA WAS CLOSED PATIENT IV WHO UNDERWENT GMT ON (B)(6) 2000 HAD A FISTULA PERSISTENCE UNDERWENT VAGINAL FLAP AND ABSCESS EXCISION. AT LAST FOLLOW UP, FISTULA WAS CLOSED PATIENT V WHO UNDERWENT GMT ON (B)(6) 2014 HAD A FISTULA PERSISTENCE UNDERWENT 3 VAGINAL FLAPS, RECTAL FLAP AND SETON PROCEDURE. AT LAST FOLLOW UP, FISTULA WAS NOT CLOSED PATIENT VI WHO UNDERWENT GMT ON (B)(6) 2016 HAD A FISTULA PERSISTENCE UNDERWENT VAGINAL FLAP. AT LAST FOLLOW UP, FISTULA WAS NOT CLOSED PATIENT VII WHO UNDERWENT GMT ON (B)(6) 2012 HAD A FISTULA PERSISTENCE UNDERWENT 2 FISTULECTOMIES, 2 VAGINAL FLAPS, RECTAL FLAP AND FISTULA PLUG. AT LAST FOLLOW UP, FISTULA WAS NOT CLOSED PATIENT VIII WHO UNDERWENT GMT ON (B)(6) 2015 HAD A FISTULA PERSISTENCE AND WOUND INFECTION WITH NECROSIS UNDERWENT EXCISION OF THE GRACILIS FLAP. AT LAST FOLLOW UP, FISTULA WAS NOT CLOSED. THE RESULTS ARE PROMISING AND SUGGEST THAT GMT IS A SAFE AND VERY EFFECTIVE OPTION FOR THE TREATMENT OF RECURRENT FISTULAS IN IBD PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1250548 PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE GAW ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention