BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ISTENT TRABECULAR MICRO-BYPASS

    MDR report key: 6677851 · Received June 29, 2017

    Report

    Report Number
    2032546-2017-00054
    Event Type
    Injury
    Date Received
    June 29, 2017
    Date of Event
    February 5, 2017
    Report Date
    August 30, 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

    LITERATURE SOURCE: FERGUSON, T.J., SWAN, R., IBACH, M., SCHWEITZER, J., SUDHAGONI, R., BERDAHL, J.P. (2017). TRABECULAR MICROBYPASS STENT IMPLANTATION WITH CATARACT EXTRACTION IN PSEUDOEXFOLIATION GLAUCOMA. J CATARACT REFRACT SURG 43:622-626. AVERAGE AGE OF THE STUDY GROUP WAS 77.42 +/- 8.51. THE MAJORITY OF THE STUDY GROUP WAS FEMALE. THE DATE THE ARTICLE WAS ACCEPTED FOR PUBLICATION, (B)(6) 2017, WAS USED AS THE DATE OF THE EVENT. DEVICE AND PATIENT IDENTIFIERS WERE NOT AVAILABLE. ANY OMITTED INFORMATION WAS NOT AVAILABLE AT THE TIME OF INITIAL REPORT. WRITTEN CORRESPONDENCE HAS BEEN SENT TO THE AUTHOR REQUESTING THE OUTSTANDING INFORMATION. SUBSEQUENT ATTEMPTS WILL BE MADE AS NECESSARY. 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 PATIENTS WITH PSEUDOEXFOLIATIVE GLAUCOMA AND PIGMENTARY GLAUCOMA, BECAUSE THE PIVOTAL TRIAL WAS NOT POWERED TO EVALUATE THE OUTCOMES OF THESE GROUPS. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). REFER TO MDR #S 2032546-2017-00071, 2032546-2017-00072, 2032546-2017-00073, AND 2032546-2017-00074, FOR THE OTHER FOUR PATIENTS REFERENCED IN THIS ARTICLE THAT REQUIRED INTERVENTION FOR POSTOPERATIVE IOP SPIKES.

    Description of Event or Problem · 1

    THROUGH REVIEW OF THE ARTICLE ¿TRABECULAR MICROBYPASS STENT IMPLANTATION WITH CATARACT EXTRACTION IN PSEUDOEXFOLIATION GLAUCOMA,¿ IT WAS LEARNED THAT AFTER STENT IMPLANTATION, SEVEN (7) EYES HAD AN INTRAOCULAR PRESSURE (IOP) SPIKE OF 15 MM HG OR HIGHER ABOVE THE BASELINE IOP. THE SPIKES RESPONDED TO TOPICAL THERAPY. THE STUDY WAS COMPRISED OF 115 EYES (86 FEMALE, 29 MALE) OF 66 PATIENTS WITH A MEAN PATIENT AGE OF 77.42 +/- 8.51. THE PURPOSE OF THE STUDY WAS TO EVALUATE THE SAFETY AND EFFICACY OF A TRABECULAR MICROBYPASS STENT COMBINED WITH CATARACT SURGERY IN PATIENTS WITH PSEUDOEXFOLIATION GLAUCOMA (PXG). POSTOPERATIVELY, PATIENTS WERE PRESCRIBED ANTIBIOTICS FOR ONE WEEK, NONSTEROIDAL ANTIINFLAMMATORY DRUGS FOR FOUR WEEKS, AND STEROID DROPS FOR ONE MONTH, WHICH STARTED AS FOUR TIMES A DAY AND WERE TAPERED TO TWO TIMES A DAY 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. THE STUDY CONCLUDED THAT TRABECULAR MICROBYPASS STENT IMPLANTATION DURING CATARACT SURGERY SAFELY AND EFFECTIVELY LOWERED IOP AND MEDICATION USE IN PATIENTS WITH MILD TO SEVERE PXG.

    Description of Event or Problem · 1

    CLINICAL FOLLOW-UP WAS REQUESTED AND ON 08/24/2017 THE AUTHOR PROVIDED DETAILS SPECIFIC TO EACH OF THE SEVEN PATIENTS WITH AN IOP SPIKE OF 15 MM HG OR HIGHER ABOVE THE BASELINE IOP. IT WAS INITIALLY REPORTED THAT ALL SEVEN PATIENTS REQUIRED TOPICAL THERAPY; HOWEVER THE AUTHOR REPORTED THAT TWO OF THE SEVEN PATIENTS HAD IOP SPIKES LIKELY RELATED TO INFLAMMATION IN THE POSTOPERATIVE PERIOD THAT RESOLVED WITHOUT INTERVENTION. THIS REPORT IS FOR PATIENT 1 OF 5 WHO REQUIRED INTERVENTION. THE PATIENT PRESENTED WITH ELEVATED IOP OF 36 MM HG ON POSTOPERATIVE DAY ONE. THE PATIENT'S IOP REMAINED ELEVATED AT ONE WEEK POSTOPERATIVE, BUT RESPONDED TO TOPICAL THERAPY. IOP REMAINED LESS THAN 20 THROUGH 24 MONTHS. THE SURGEON REPORTED THAT THE PATIENT'S IOP WAS LIKELY ELEVATED DUE TO INFLAMMATION IN THE POSTOPERATIVE PERIOD, WHICH IS MORE COMMON IN THE PSEUDOEXFOLIATION GLAUCOMA (PXG) POPULATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    457093 ISTENT TRABECULAR MICRO-BYPASS INTRAOCULAR PRESSURE LOWERING IMPLANT OGO GLAUKOS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention