BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

    MDR report key: 7379003 · Received March 28, 2018

    Report

    Report Number
    2210968-2018-71714
    Event Type
    Injury
    Date Received
    March 28, 2018
    Report Date
    March 9, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K022269
    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. NO SPECIFIC PATIENT INFORMATION REGARDING EVENTS HAS BEEN PROVIDED. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. IF FURTHER DETAILS ARE RECEIVED AT THE 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 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 USED IN THIS PROCEDURE? CITATION: PLOS MED. 8 (12): E1001137. DOI: 10.1371/JOURNAL.PMED.1001137 - (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: ¿TITLE: ABSORBABLE VERSUS SILK SUTURES FOR SURGICAL TREATMENT OF TRACHOMATOUS TRICHIASIS IN ETHIOPIA: A RANDOMISED CONTROLLED TRIAL¿ AUTHORS: SAUL N. RAJAK, ESMAEL HABTAMU, HELEN A. WEISS, AMIR BEDRI KELLO, TESHOME GEBRE, ASRAT GENET, ROBIN L. BAILEY, DAVID C. W. MABEY, PENG T. KHAW, CLARE E. GILBERT, PAUL M. EMERSON, MATTHEW J. BURTON CITATION: PLOS MED. 8 (12): E1001137. DOI: 10.1371/JOURNAL.PMED.1001137. TRACHOMA CAUSES BLINDNESS THROUGH AN ANATOMICAL ABNORMALITY CALLED TRICHIASIS (LASHES TOUCHING THE EYE). TRICHIASIS CAN RECUR AFTER CORRECTIVE SURGERY. THE AUTHORS TESTED THE HYPOTHESIS THAT USING ABSORBABLE SUTURES INSTEAD OF SILK SUTURES MIGHT REDUCE THE RISK OF RECURRENT DISEASE AMONG PATIENTS WITH MAJOR TRICHIASIS IN A RANDOMIZED TRIAL. A TOTAL OF 1300 PATIENTS WITH MAJOR TRICHIASIS WERE INCLUDED IN THE STUDY. OF WHICH, 650 PATIENTS WERE ALLOCATED TO THE SILK GROUP AND ANOTHER 650 PATIENTS WERE ALLOCATED TO THE VICRYL GROUP. DURING THE SURGICAL PROCEDURE, 3 SETS OF EVERTING SUTURES WERE PLACED RUNNING DOWN AND FORWARD FROM THE UPPER CUT EDGE OF THE TARSAL PLATE TO EMERGE THROUGH THE SKIN JUST ABOVE THE EYELASHES. AS THE SUTURES ARE TIGHTENED, THEY EXTERNALLY ROTATE THE LOWER BORDER OF THE EYELID. THE SUTURES WERE EITHER MERSILK 4-0 SUTURES OR VICRYL 5-0 SUTURES. ALL SUTURES HAD 3/8 CIRCLE, 16-MM CUTTING NEEDLES AT EACH END. IN THE SILK GROUP, REPORTED COMPLICATIONS INCLUDED RECURRENT TRICHIASIS (N-120), INFECTION/ERYTHEMATOUS SWELLING/CONJUNCTIVITIS (N-7), NOTCHING (N-70), AND RESIDUAL SUTURE FRAGMENTS (N-15). IN THE VICRYL GROUP, REPORTED COMPLICATIONS INCLUDED RECURRENT TRICHIASIS (N-114), INFECTION/ERYTHEMATOUS SWELLING/CONJUNCTIVITIS (N-3), NOTCHING (N-84), AND RESIDUAL SUTURE FRAGMENTS (N-1). IT WAS REPORTED THAT NO PARTICIPANTS IN THE SILK GROUP WERE RECORDED AS NOT HAVING THEIR SUTURES REMOVED AT POST-OPERATIVE DAY 7 TO 10. HOWEVER, IT WAS POSSIBLE THAT INCOMPLETE REMOVAL COULD HAVE CAUSED SUTURE FRAGMENTS TO BE LEFT IN SITU. IT WAS CONCLUDED THAT THERE WAS NO EVIDENCE THAT USE OF ABSORBABLE VICRYL SUTURES WERE ASSOCIATED WITH A LOWER PREVALENCE OF TRICHIASIS RECURRENCE AT 1 YEAR POST-SURGERY THAN SILK SUTURES. HOWEVER, FROM A PROGRAMMATIC PERSPECTIVE, VICRYL SUTURES OFFERS THE MAJOR ADVANTAGE THAT PATIENTS DO NOT HAVE TO BE SEEN SOON AFTER SURGERY FOR SUTURE REMOVAL. THE POSTOPERATIVE REVIEW AFTER SURGERY USING ABSORBABLE POLYGLACTIN-910 SUTURES CAN BE DELAYED FOR 3¿6 MONTHS, WHICH MIGHT ALLOW US TO BETTER DETERMINE WHETHER A PATIENT NEEDS ADDITIONAL SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    219345 VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention