BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT

    MDR report key: 7647628 · Received June 28, 2018

    Report

    Report Number
    2210968-2018-73920
    Event Type
    Injury
    Date Received
    June 28, 2018
    Report Date
    June 13, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    GAW
    PMA / PMN Number
    K133356
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: 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? RESPONSE RECEIVED FROM AUTHOR: ¿THIS ARTICLE STRONGLY SUPPORTS THE USE OF 10-0 PROLINE FOR SUTURING IOLS AND REFUTES PREVIOUS PAPERS INDICATING A HIGH RATE OF SUTURE BREAKAGE. A 0.05% BREAKAGE RATE IS REMARKABLY GOOD AND SUPPORTS ALL OF US CONTINUING TO USE THE ETHICON 10-0 PROLINE FOR FIXATION OF IOLS.¿ CITATION: AM J OPHTHALMOL 2018;189:10¿16; DOI: HTTPS://DOI.ORG/10.1016/J.AJO.2018.01.034. [(B)(4).PDF].

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: "TITLE: LONG-TERM OUTCOME OF PARS PLANA VITRECTOMY AND SUTURED SCLERAL-FIXATED POSTERIOR CHAMBER INTRAOCULAR LENS IMPLANTATION OR REPOSITIONING" AUTHOR(S): GREGG T. KOKAME, RYAN T. YANAGIHARA, JESSICA G. SHANTHA, AND KYLE N. KANEKO. CITATION: AM J OPHTHALMOL 2018;189:10¿16; DOI: HTTPS://DOI.ORG/10.1016/J.AJO.2018.01.034. THIS RETROSPECTIVE, CONSECUTIVE, INTERVENTIONAL CASE SERIES AIMED TO ASSESS THE LONG-TERM STABILITY OF SUTURED SCLERAL-FIXATED POSTERIOR CHAMBER INTRAOCULAR LENSES (PCIOLS) PERFORMED IN COMBINATION WITH PARS PLANA VITRECTOMY. FROM 25 JAN 1990 TO 18 OCT 2012, 118 EYES OF 111 PATIENTS WITH DISLOCATED OR SUBLUXATED PCIOLS (N=72 EYES), IN-THE-BAG PCIOL DISLOCATIONS (N=29 EYES), CRYSTALLINE LENS DISLOCATIONS OR SUBLUXATIONS (N=11 EYES), ANTERIOR CHAMBER IOL COMPLICATIONS (N=2) AND APHAKIA (N=4) UNDERWENT SUTURED SCLERAL FIXATION OF AT LEAST 1 HAPTIC OF A POSTERIOR CHAMBER INTRAOCULAR LENS WITH 10-0 PROLENE SUTURES COMBINED WITH PARS PLANA VITRECTOMY. THE FIXATION KNOT-TYING TECHNIQUE REQUIRED 2 SEPARATE 10-0 PROLENE SUTURES TIED INTO 1 COMBINED KNOT¿1 SUTURE CLOSED THE FIXATION SCLEROTOMY AND CREATED THE SCLERAL FIXATION, AND 1 SUTURE LOOPED TOGETHER AROUND THE HAPTIC OF THE PCIOL, SECURING THE HAPTIC TO THE SCLERAL FIXATION SITE. THERE WERE 4 CASES OF REDISLOCATIONS, BUT ONLY ONE CASE WAS DUE TO SUTURE BREAKAGE WHICH WAS SUCCESSFULLY MANAGED WITH A REPEAT 10-0 PROLENE FIXATION SUTURE WITH STABLE POSITIONING FOR MORE THAN 7 YEARS AFTER THE SECOND PROCEDURE. THIS SCLERAL FIXATION SUTURE WAS NOTED TO BE MISSING AROUND AN INTACT PCIOL, SUGGESTING THAT SUTURE BREAKAGE HAD OCCURRED. THERE WERE 6 CASES OF SUTURE EXPOSURES WHICH WAS TREATED BY COVERING WITH GRAFT MATERIAL (N=4 PERICARDIAL GRAFTS, N=1 BANK SCLERA AND N=1 BANK CORNEAL TISSUE). SCLERAL FIXATION SUTURES WITH 10-0 POLYPROPYLENE PROVIDE EXCELLENT LONG-TERM FIXATION OF PCIOLS, WITH A LESS THAN 0.5% INCIDENCE OF SUTURE BREAKAGE AND DOCUMENTED SUTURE STABILITY FOR UP TO 24+ YEARS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    488652 PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT SUTURE, NONABSORBABLE GAW ETHICON INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention