BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ISTENT TRABECULAR MICRO-BYPASS

    MDR report key: 9795815 · Received March 5, 2020

    Report

    Report Number
    2032546-2020-00028
    Event Type
    Malfunction
    Date Received
    March 5, 2020
    Date of Event
    December 30, 2019
    Report Date
    April 16, 2020
    Manufacturer
    GLAUKOS CORPORATION
    Product Code
    OGO
    PMA / PMN Number
    P080030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    MFR# (B)(4). PLEASE REFERENCE 2032546-2020-00026 FOR REPORTED SERIOUS INJURY.

    Description of Event or Problem · 0

    THROUGH FOLLOW-UP, THE FOLLOWING ADDITIONAL INFORMATION WAS RECEIVED. ACCORDING TO THE SURGEON, THE STENT CAUSED OR CONTRIBUTED TO THE REPORTED POSTOPERATIVE EVENTS IN NARROW ANGLES EYES. THE PATIENT¿S IOP WAS REPORTED AS ¿STILL CONTROLLED¿. THIS FOLLOW-UP REPORT IS ASSOCIATED WITH INITIAL REPORT OF STENTS OCCLUSIONS WITHOUT MEDICAL INTERVENTION.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT A NON-REPRODUCIBLE, HIGHER THAN EXPECTED VITROS TSH RESULT WAS OBTAINED FROM A SINGLE PATIENT SAMPLE WHEN TESTED ON A VITROS 5600 SYSTEM. THE DEFINITIVE ASSIGNABLE CAUSE COULD NOT BE DETERMINED. VITROS TSH PRECISION TESTING PERFORMED WAS WITHIN ACCEPTABLE GUIDELINES, SUGGESTING AN INSTRUMENT ISSUE WAS NOT LIKELY A CONTRIBUTING FACTOR. HISTORICAL QUALITY CONTROL RESULTS FOR THE VITROS TSH REAGENT LOT 6055 WAS ACCEPTABLE, INDICATING A VITROS TSH REAGENT RELATED ISSUE DID NOT LIKELY CONTRIBUTE TO THE EVENT. ADDITIONALLY, ONGOING TRACKING AND TRENDING OF COMPLAINTS HAS NOT IDENTIFIED ANY SIGNALS THAT WOULD INDICATE A POTENTIAL SYSTEMATIC ISSUE WITH VITROS TSH REAGENT LOT 6055. IN ADDITION, PRE-ANALYTICAL SAMPLE PROCESSING COULD NOT BE RULED OUT AS A CONTRIBUTING FACTOR. THE CUSTOMER IS NOT ADHERING TO THE SAMPLE COLLECTION DEVICE MANUFACTURER¿S RECOMMENDATIONS FOR SAMPLE CENTRIFUGATION, THEREFORE; IMPROPER PRE-ANALYTICAL SAMPLE HANDLING (CENTRIFUGATION) CANNOT BE RULED OUT AS CONTRIBUTING TO THE EVENT.

    Description of Event or Problem · 1

    THROUGH A REVIEW OF AN ARTICLE TITLED ¿PHACOEMULSIFICATION VERSUS PHACOEMULSIFICATION WITH MICROBYPASS STENT IMPLANTATION IN PRIMARY ANGLE CLOSURE AND PRIMARY ANGLE CLOSURE GLAUCOMA: A RANDOMIZED SINGLE-MASKED CLINICAL STUDY ¿, THE FOLLOWING WAS REPORTED IN THE PHACO-ISTENT GROUP. REPORTEDLY, FOLLOWING CATARACT PLUS STENT PROCEDURES, THERE WERE POSTOPERATIVE COMPLICATIONS CONSISTED OF STENT OCCLUSION WITH IRIS WHICH OCCURRED IN FIVE (5) EYES. PER REPORT, ONE (1) EYE REQUIRED GLAUCOMA MEDICATION AT ONE (1) MONTH POSTOP AND ANOTHER EYE REQUIRED GLAUCOMA MEDICATION AT THREE (3) MOTHS POST-OPERATIVELY. IN ADDITION, A CORNEAL EDEMA OCCURRED IN ONE (1) EYE, HYPHEMA (1), IRIS ATROPHY (1) AND ENDOTHELIAL BLOOD STAINING (1). AS REPORTED, ALL POSTOPERATIVE COMPLICATIONS DID NOT REQUIRE ANY SECONDARY SURGICAL INTERVENTION TO REPOSITION OR REPLACE THE STENT. ANY OMITTED INFORMATION WAS NOT AVAILABLE AT THE TIME OF THIS REPORT. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THIS REPORT REFERENCES THE STENTS OCCLUSIONS WITHOUT MEDICAL INTERVENTION. PLEASE SEE THE ATTACHED ARTICLE FOR FURTHER DETAILS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    258430 ISTENT TRABECULAR MICRO-BYPASS INTRAOCULAR PRESSURE LOWERING IMPLANT OGO GLAUKOS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR