BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ISTENT TRABECULAR MICRO-BYPASS

    MDR report key: 6546091 · Received May 4, 2017

    Report

    Report Number
    2032546-2017-00032
    Event Type
    Injury
    Date Received
    May 4, 2017
    Date of Event
    March 1, 2013
    Report Date
    June 19, 2017
    Manufacturer
    GLAUKOS CORPORATION
    Product Code
    OGO
    PMA / PMN Number
    P080030
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DATE THE ARTICLE WAS ACCEPTED FOR PUBLICATION, (B)(6) 2016, WAS USED AS THE DATE OF EVENT. DEVICE IDENTIFIERS ARE NOT AVAILABLE. THE DEVICES REMAIN IMPLANTED IN THE PATIENTS AND ARE NOT AVAILABLE FOR EVALUATION. IOP ELEVATION IS IDENTIFIED IN THE DEVICE LABELING AS A KNOWN INHERENT RISK OF GLAUCOMA STENT SURGERY. THE DEVICE LABELING WAS REVIEWED, AND STATES THAT THE SAFETY AND EFFECTIVENESS OF THE ISTENT TRABECULAR MICRO-BYPASS STENT HAS NOT BEEN ESTABLISHED IN PSEUDOPHAKIC PATIENTS WITH GLAUCOMA. (B)(4).

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: (CONCLUSION). THE EXACT ADVERSE EVENT ONSET DATE AND IMPLANT DATE ARE NOT KNOWN; HOWEVER THE PROCEDURE WAS COMPLETED IN (B)(6) 2013 AND THE SURGEON REPORTED THAT THE IOP ELEVATION WAS NOTED ONE MONTH POSTOPERATIVELY. THE DEVICE LABELING WAS REVIEWED AND SEVERE OAG IS NOT INCLUDED IN THE INDICATIONS FOR USE. MFR REFERENCE # (B)(4). REFER TO MDRS 2032546-2017-00050 AND 2032546-2017-00051 FOR THE OTHER TWO PATIENTS REPORTED IN THIS ARTICLE WITH POSTOPERATIVE IOP ELEVATION.

    Description of Event or Problem · 1

    THROUGH REVIEW OF THE ARTICLE ¿EVALUATION OF A TRABECULAR MICRO-BYPASS STENT IN PSEUDOPHAKIC PATIENTS WITH OPEN-ANGLE GLAUCOMA¿ IT WAS LEARNED THAT THREE EYES EXPERIENCED AN INTRAOCULAR PRESSURE (IOP) SPIKE GREATER THAN OR EQUAL TO 15 MM HG IN THE FIRST MONTH POSTOPERATIVELY, AND EACH RESPONDED TO TOPICAL THERAPY. THE STUDY WAS COMPRISED OF 42 PSEUDOPHAKIC EYES THAT WERE IMPLANTED WITH ONE STENT BETWEEN OCTOBER 2012 AND MAY 2015. THE MEAN AGE OF THE 26 FEMALE AND 16 MALE SUBJECTS WAS 80.07 +/- 8.54. THE PURPOSE OF THE STUDY WAS TO EVALUATE THE SAFETY AND EFFICACY ONE TRABECULAR MICROBYPASS STENT ALONE AS A SOLE PROCEDURE FOR PSEUDOPHAKIC OPEN-ANGLE GLAUCOMA (OAG). POSTOPERATIVELY, PATIENTS WERE PRESCRIBED ANTIBIOTICS FOR ONE WEEK, NSAIDS FOR FOUR WEEKS, AND STEROID DROPS FOR ONE MONTH WHICH STARTED AS QID AND WERE TAPERED TO BID AFTER ONE WEEK. PATIENTS WERE KEPT ON THEIR PREOPERATIVE OCULAR HYPOTENSIVE MEDICATIONS FOR AT LEAST ONE WEEK OR UNTIL THE PATIENT¿S IOP WAS DEEMED CLINICALLY ACCEPTABLE BY THE OPERATING PHYSICIAN. NO SPECIFIC GUIDELINES WERE ESTABLISHED TO DETERMINE WHEN TO ADD OR REMOVE OCULAR HYPOTENSIVE MEDICATIONS, AND MEDICATION ADDITION OR REMOVAL WAS BASED ON CLINICAL JUDGMENT. THE STUDY CONCLUDED THAT IMPLANTATION OF THE MICRO-BYPASS STENT IN PSEUDOPHAKIC PATIENTS WITHOUT CONCOMITANT CATARACT SURGERY PROVIDES A SUSTAINED REDUCTION IN IOP AT TWO YEARS POSTOPERATIVELY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Description of Event or Problem · 1

    THROUGH REVIEW OF THE ARTICLE ¿EVALUATION OF A TRABECULAR MICRO-BYPASS STENT IN PSEUDOPHAKIC PATIENTS WITH OPEN-ANGLE GLAUCOMA¿ IT WAS LEARNED THAT THREE EYES EXPERIENCED AN INTRAOCULAR PRESSURE (IOP) SPIKE GREATER THAN OR EQUAL TO 15 MM HG IN THE FIRST MONTH POSTOPERATIVELY, AND EACH RESPONDED TO TOPICAL THERAPY. THE STUDY WAS COMPRISED OF 42 PSEUDOPHAKIC EYES THAT WERE IMPLANTED WITH ONE STENT BETWEEN (B)(6) 2012 AND (B)(6) 2015. THE MEAN AGE OF THE (B)(6) FEMALE AND (B)(6) MALE SUBJECTS WAS 80.07 +/- 8.54. THE PURPOSE OF THE STUDY WAS TO EVALUATE THE SAFETY AND EFFICACY ONE TRABECULAR MICROBYPASS STENT ALONE AS A SOLE PROCEDURE FOR PSEUDOPHAKIC OPEN-ANGLE GLAUCOMA (OAG). POSTOPERATIVELY, PATIENTS WERE PRESCRIBED ANTIBIOTICS FOR ONE WEEK, NSAIDS FOR FOUR WEEKS, AND STEROID DROPS FOR ONE MONTH WHICH STARTED AS QID AND WERE TAPERED TO BID AFTER ONE WEEK. PATIENTS WERE KEPT ON THEIR PREOPERATIVE OCULAR HYPOTENSIVE MEDICATIONS FOR AT LEAST ONE WEEK OR UNTIL THE PATIENT¿S IOP WAS DEEMED CLINICALLY ACCEPTABLE BY THE OPERATING PHYSICIAN. NO SPECIFIC GUIDELINES WERE ESTABLISHED TO DETERMINE WHEN TO ADD OR REMOVE OCULAR HYPOTENSIVE MEDICATIONS, AND MEDICATION ADDITION OR REMOVAL WAS BASED ON CLINICAL JUDGMENT. THE STUDY CONCLUDED THAT IMPLANTATION OF THE MICRO-BYPASS STENT IN PSEUDOPHAKIC PATIENTS WITHOUT CONCOMITANT CATARACT SURGERY PROVIDES A SUSTAINED REDUCTION IN IOP AT TWO YEARS POSTOPERATIVELY. CLINICAL FOLLOW-UP WAS REQUESTED AND ON 06/16/2017 THE AUTHOR PROVIDED ADDITIONAL INFORMATION SPECIFIC TO EACH OF THE THREE PATIENTS. ONE OF THE PATIENTS PRESENTED ONE MONTH POSTOPERATIVELY WITH IOP ELEVATED FROM 20 MM HG TO 38 MM HG. THE PATIENT RESPONDED TO TOPICAL THERAPY AND IOP REMAINED LESS THAN 21 MM HG THROUGH THE 24 MONTH FOLLOW-UP. THE SURGEON REPORTED THAT THE IOP ELEVATION WAS LIKELY DUE TO INFLAMMATION IN THE POSTOPERATIVE PERIOD AND THE SEVERITY OF THE OPEN-ANGLE GLAUCOMA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    325550 ISTENT TRABECULAR MICRO-BYPASS INTRAOCULAR PRESSURE LOWERING IMPLANT OGO GLAUKOS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 91 YR Required Intervention