BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPASS SYSTEM

    MDR report key: 8623880 · Received May 20, 2019

    Report

    Report Number
    2523835-2019-00214
    Event Type
    Injury
    Date Received
    May 20, 2019
    Date of Event
    March 13, 2019
    Report Date
    July 26, 2019
    Manufacturer
    TRANSCEND MEDICAL INC.
    Product Code
    OGO
    PMA / PMN Number
    P150037
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION PROVIDED. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Additional Manufacturer Narrative · 0

    ONE TRIMMED PIECE OF A COMPANY STENT WAS RECEIVED IN A VIAL. THE TRIMMED STENT WAS VISUALLY INSPECTED AND DAMAGE CONSISTENT WITH TRIMMING WAS OBSERVED; THE DISTAL COLLAR AND FIRST AND SECOND RETENTION RINGS WERE RETURNED WITH A JAGGED CUT BEHIND THE SECOND RETENTION RING. THE REPORTER HAS NOT PROVIDED SUFFICIENT CLINICAL DATA FOR EVALUATION WITH THIS COMPLAINT. THEREFORE, THE REPORTED EVENT COULD NOT BE VERIFIED. A REVIEW OF THE DEVICE HISTORY RECORD TRACEABLE TO THE REPORTED LOT NUMBER INDICATES THAT THE PRODUCT WAS PROCESSED AND RELEASED ACCORDING TO THE PRODUCT¿S ACCEPTANCE CRITERIA. A COMPLAINT HISTORY EXAMINATION INDICATES THERE ARE NO ADDITIONAL COMPLAINTS ASSOCIATED WITH THE LOT FOR THE REPORTED ISSUE. PHOTO PROVIDED WAS REVIEWED BY THE INVESTIGATION SITE. BECAUSE THE SAMPLE RETURNED COULD NOT VERIFY THE REPORTED EVENT, SUFFICIENT CLINICAL DATA WAS NOT RECEIVED, AND THE DEVICE HISTORY RECORD REVIEW OF THE LOT NUMBER PROVIDED INDICATED THE PRODUCT WAS PROCESSED AND RELEASED ACCORDING TO THE PRODUCT¿S ACCEPTABLE CRITERIA, THE ROOT CAUSE FOR THE CUSTOMER COMPLAINT ISSUE CANNOT BE DETERMINED. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION HAS BEEN RECEIVED STATING THE PATIENT UNDERWENT A SECONDARY PROCEDURE FOR STENT SHORTENING. THE PATIENT ALSO EXPERIENCED EPITHEL BULLAE AND DESCEMET FOLDS.

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. THE PRODUCT HISTORY AND BATCH RECORDS WERE REVIEWED AND DOCUMENTATION INDICATED THE PRODUCT MET RELEASE CRITERIA. THE PRODUCT INVESTIGATION COULD NOT IDENTIFY A ROOT CAUSE. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 1

    A HEALTH PROFESSIONAL REPORTED THAT AFTER A GLAUCOMA STENT IMPLANT SURGERY, A PATIENT EXPERIENCED CORNEAL DECOMPENSATION AND ENDOTHELIAL TOUCH FROM THE STENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    416486 CYPASS SYSTEM INTRAOCULAR PRESSURE LOWERING IMPLANT OGO TRANSCEND MEDICAL INC. NA FG-012016-001

    Patients

    Seq Age Sex Outcome Treatment
    1 Other DEXAGENT