BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT

    MDR report key: 7661623 · Received July 3, 2018

    Report

    Report Number
    2210968-2018-74070
    Event Type
    Injury
    Date Received
    July 3, 2018
    Report Date
    June 7, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    GAW
    PMA / PMN Number
    K133356
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DATE SENT TO THE FDA: 07/03/2018. 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. IF FURTHER DETAILS ARE RECEIVED AT THE LATER DATE, A SUPPLEMENTAL MEDWATCH WILL BE SENT. 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? WEB ADDRESS: HTTP://DX.DOI.ORG/10.1016/J.JCRS.2013.05.014 . CITATION: J CATARACT REFRACT SURG 2013; 39:979¿983. [(B)(4)].

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE TITLE : TRANSSCLERAL SUTURING OF THE IMPLANTABLE MINIATURE TELESCOPE; AUTHOR : MARJAN FARID, MD; WEB ADDRESS: HTTP://DX.DOI.ORG/10.1016/J.JCRS.2013.05.014. CITATION: J CATARACT REFRACT SURG 2013; 39:979¿983. THE AUTHOR DESCRIBED A TECHNIQUE FOR TRANSSCLERAL SUTURING OF THE IMPLANTABLE MINIATURE TELESCOPE DEVICE FOR END-STAGE AGE-RELATED MACULAR DEGENERATION (AMD). IT PROVIDES STABILIZATION AND CENTRATION OF THE IMPLANTABLE MINIATURE TELESCOPE DEVICE IN THE CASE OF CAPSULE RUPTURE OR SEVERE ZONULAR DIALYSIS. (B)(6)-YEAR-OLD WOMAN WITH END-STAGE AMD WAS DEEMED A GOOD CANDIDATE FOR THE IMPLANTABLE MINIATURE TELESCOPE AFTER PREOPERATIVE EVALUATION BY RETINAL, LOW-VISION, AND CORNEAL SPECIALISTS. AFTER SUCCESSFUL PHACOEMULSIFICATION OF THE CATARACT IN HER LEFT EYE, A 180-DEGREE TEMPORAL CONJUNCTIVAL PERITOMY WAS PERFORMED. AN AB INTERNO TECHNIQUE OF TRANSSCLERAL FIXATION WAS USED TO SECURE THE DEVICE. A DOUBLE-ARMED PROLENE 9-0 SUTURE ON A CTC-6 NEEDLE WAS THROWN THROUGH THE EYELET OF THE HAPTIC AND EXITED THROUGH THE SCLERA AT THE LEVEL OF THE CILIARY SULCUS, APPROXIMATELY 2.0 MM POSTERIOR TO THE LIMBUS. THE SECOND ARM OF THE SUTURE WAS SIMILARLY PLACED THROUGH THE SCLERA AT A POINT APPROXIMATELY 2.0 MM FROM THE PREVIOUS EXIT SITE. WITH AN AB INTERNO TECHNIQUE, A SCLERAL FLAP CAN BE MADE PRIOR TO PASSING THE NEEDLE SO THE SUTURE KNOT REMAINS BURIED BENEATH THE FLAP. ALTERNATIVELY, THE SUTURE CAN BE TIED ON THE SCLERA WITH THE SUTURE ENDS LEFT LONG AND TUCKED TO LIE FLAT BENEATH CONJUNCTIVA, AS WAS DONE IN THIS CASE. THE MAIN WOUND WAS CLOSED WITH NYLON SUTURES AND THE CONJUNCTIVA WAS CLOSED WITH VICRYL 8-0 SUTURES. AT 10-DAY EXAMINATION POST-OPERATIVELY, REPORTED COMPLICATIONS INCLUDED VERY MILD CORNEAL EDEMA, SIGNIFICANT DEBRIS AND PIGMENT CELLS COATED THE OPTIC SURFACE, AND MILD VITREOUS HEMORRHAGE. AT 1-YEAR VISIT, THE DEBRIS ON THE OPTIC WAS COMPLETELY CLEAR AND THE IMPLANTABLE MINIATURE TELESCOPE REMAINED WELL POSITIONED. IT WAS CONCLUDED THAT THIS TECHNIQUE OFFERS A SAFE AND RELIABLE METHOD FOR SECURING THE IMPLANTABLE MINIATURE TELESCOPE DEVICE IN CASES OF CAPSULE DISRUPTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    499828 PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT SUTURE, NONABSORBABLE GAW ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention