BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EX-PRESS MINI GLAUCOMA SHUNT

    MDR report key: 2003640 · Received February 24, 2011

    Report

    Report Number
    3003701944-2011-00004
    Event Type
    Injury
    Date Received
    February 24, 2011
    Report Date
    January 25, 2011
    Manufacturer
    OPTONOL, LTD
    Product Code
    KYF
    PMA / PMN Number
    K030350
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: NO SAMPLES WERE RETURNED FOR EVAL; THEREFORE, THE CONDITION OF THE PRODUCT COULD NOT BE VERIFIED. NO LOT NUMBER WAS INDICATED FOR THIS COMPLAINT; THEREFORE, THE DEVICE HISTORY RECORD (DHR) FOR THE LOT COULD NOT BE REVIEWED FOR ABNORMALITIES THAT COULD HAVE CONTRIBUTED TO THE COMPLAINT. BECAUSE A SAMPLE WAS NOT RETURNED AND NO LOT NUMBER WAS INDICATED FOR THIS COMPLAINT, THE ROOT CAUSE CANNOT BE DETERMINED. ADDITIONAL INFO WAS REQUESTED VIA MAIL AND FAX (B)(6) 2011 AND BY PHONE ON (B)(6) 2011. CITATION: STEWART, R.M., DIAMOND, J.G., ASHMORE, E.D., AYYALA, R.S. (2005) COMPLICATIONS FOLLOWING EX-PRESS GLAUCOMA SHUNT IMPLANTATION. AMERICAN JOURNAL OPHTHALMOLOGY 2005; 140-000-000, ELSEVIER, INC. (B)(4). THIS REPORT WAS MAILED TO FDA ON: (B)(6) 2011. (B)(4).

    Description of Event or Problem · 1

    IN A LITERATURE ARTICLE, "COMPLICATIONS FOLLOWING EX-PRESS GLAUCOMA SHUNT IMPLANTATION", PUBLISHED IN THE AMERICAN JOURNAL OF OPHTHALMOLOGY IN 2005 (ELSEVIER INC, 0002-9394/05), AN OPHTHALMOLOGIST REPORTED A PT (CASE 3) WITH OPEN-ANGLE GLAUCOMA WAS REFERRED FOR MANAGEMENT OF PAIN FIVE DAYS AFTER INSERTION OF THE SHUNT IN HIS LEFT EYE (OS). HYPOTONY WITH THAT ANTERIOR CHAMBER ON DAY 1 WAS TREATED WITH SODIUM HYALURONATE INJECTION AND A SIMILAR PROCEDURE ON POST-OP DAYS 3 AND 4. HE WAS REFERRED AFTER HIS THIRD INJECTION WHEN HE DEVELOPED SEVERE PAIN. OCULAR EXAMINATION WAS CONDUCTED AND FINDINGS INCLUDE INTRAOCULAR PRESSURE (IOP) OF 20 MM HG, A LOW DIFFUSE BLEB OVERLYING THE SHUNT, AND A PERIPHERAL SUPRACHOROIDAL HEMORRHAGE WHICH RESOLVED AFTER TWO WEEKS OF CONSERVATIVE TREATMENT. THE PT UNDERWENT AN AHMED VALVE PLACEMENT TWO MONTHS LATER IN THE SUPRANASAL QUADRANT BECAUSE OF SURGERY FAILURE OF THE SHUNT FROM SUBCONJUNCTIVAL FIBROSIS. THE SHUNT WAS NOT REMOVED. A YEAR LATER, ROUTINE EXAMINATION REVEALED 20/30 VISION, 14 MM HG IOP AND CONJUNCTIVAL EROSION WITH EXPOSURE OF THE SHUNT RIM. THE SHUNT WAS EXTRACTED WHICH REQUIRED INITIAL SURGICAL EXTENSION OF THE ENTRY PORTAL FOLLOWED BY MECHANICAL TWISTING OF THE DEVICE TO DISLODGE IT FROM THE EYE WALL. AT A FOLLOW-UP VISIT TWO MONTHS LATER, IOP WAS 11 MM HG AND VISION WAS 20/30. THE ARTICLE CONCLUDED THAT COMPLICATIONS AND FAILURE FROM FIBROSIS AFTER SHUNT IMPLANTATION CAN OCCUR WITH ANY GLAUCOMA SURGERY. AN INFLATION-DEFLATION PHENOMENON SUCH AS THE REPEATED INJECTIONS OF SODIUM HYALURONATE WITH RECURRENT FLAT ANTERIOR CHAMBERS MAY HAVE CONTRIBUTED TO THE DEVELOPMENT OF DELAYED SUPRACHOROIDAL HEMORRHAGE IN THIS PT. THIS IS MDR # 3 OF 4 RELATED MDRS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EX-PRESS MINI GLAUCOMA SHUNT AQUEOUS SHUNT KYF OPTONOL, LTD NI NI

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention