BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

    MDR report key: 7359315 · Received March 21, 2018

    Report

    Report Number
    2210968-2018-71587
    Event Type
    Injury
    Date Received
    March 21, 2018
    Report Date
    March 9, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K022269
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    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 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? CITATION: J GLAUCOMA. 2017; 26: E146 E149. DOI: 10.1097/IJG.0000000000000626 - [(B)(4)- POON 2016.PDF].

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: "TITLE: ENDOSCOPIC CYCLOPHOTOCOAGULATION FOR THE TREATMENT OF GLAUCOMA IN BOSTON KERATOPROSTHESIS TYPE II PATIENT" AUTHORS: LINDA YI-CHIEH POON, MD, JAMES CHODOSH, MD, MPH, DEMETRIOS G. VAVVAS, MD, PHD, CLAES H. DOHLMAN, MD, PHD, TERESA C. CHEN, MD CITATION: J GLAUCOMA. 2017; 26: E146 E149. DOI: 10.1097/IJG.0000000000000626. THE AUTHORS DESCRIBE THE SURGICAL TECHNIQUE OF ENDOSCOPIC CYCLOPHOTOCOAGULATION IN A BOSTON KERATOPROSTHESIS TYPE II PATIENT. THIS PATIENT WITH OCULAR CICATRICIAL PEMPHIGOID OU HAD PARS PLANA ENDOSCOPIC CYCLOPHOTOCOAGULATION THROUGH WOUNDS CREATED IN THE EYELIDS. A (B)(6)-YEAR-OLD WOMAN WITH OCULAR CICATRICIAL PEMPHIGOID OU UNDERWENT COMBINED BOSTON KPRO TYPE II SURGERY, LENS EXTRACTION, PARS PLANA VITRECTOMY, PARS PLANA AHMED VALVE SURGERY, AND PERMANENT TARSORRHAPHY OD. HOWEVER, AT 3 YEARS AFTER THE INITIAL SURGERY, GLAUCOMA PROGRESSION WAS DETECTED IN HER RIGHT EYE WITH AN INCREASED CUPPING AND WORSENING VFS, WITH STABLE 20/20 VISION OD AND COUNTING FINGER VISION OS. DURING HER REPEAT SURGERY AND UPON COMPLETION, THE SUPERONASAL INFUSION PORT AND CANNULA WAS REMOVED. THE SCLERAL WOUNDS WERE CLOSED WITH VICRYL 7-0 SUTURES, AND THE EYELID WOUNDS WERE CLOSED WITH INTERRUPTED VICRYL 7-0 SUTURES IN THE DEEP LAYERS, AND RUNNING 8-0 SUTURES IN THE SUPERFICIAL LAYERS. POST-OPERATIVELY, THE REPORTED COMPLICATIONS INCLUDED EYE PRESSURE BY PALPATION AND THERE WAS A MODERATE AMOUNT OF VITREOUS HAZE, WHICH WAS THOUGHT TO BE STERILE VITRITIS WHICH WAS RESOLVED AFTER AN ORAL REGIMEN OF PREDNISOLONE. IT WAS CONCLUDED THAT GENERAL SURGICAL APPROACH OF PERFORMING ECP IN KPRO TYPE II PATIENTS, WHILE ALSO DESCRIBING 2 POSSIBLE INCISION TYPES, COMPARED WITH AHMED VALVE IMPLANTATION REQUIRES RE-OPENING OF THE INITIALLY COMPLETED TARSORRHAPHY. THE ECP HAS THE ADVANTAGES OF A SMALLER INCISION, SHORTER SURGERY TIME, AND QUICKER RECOVERY. FURTHERMORE, THE MINIMALLY INVASIVE APPROACH THROUGH THE EYELID MINIMIZES POTENTIAL EXCESSIVE SURGICAL TRAUMA TO THE EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    199750 VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention