BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BAERVELDT GLAUCOMA IMPLANT

    MDR report key: 12014040 · Received June 16, 2021

    Report

    Report Number
    9614546-2021-07172
    Event Type
    Injury
    Date Received
    June 16, 2021
    Report Date
    June 16, 2024
    Manufacturer
    AMO MANUFACTURING NETHERLANDS
    Product Code
    KYF
    PMA / PMN Number
    K955455
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IN THE REPORT SUBMITTED JUNE 16, 2021 ((B)(4)), AN INCORRECT MODEL NUMBER AND CATALOG NUMBER WAS INADVERTENTLY SUBMITTED. THIS REPORT CONTAINS THE CORRECTED MODEL NUMBER AND CATALOG NUMBER. SECTION D4 - MODEL #: UNK_GLAUCOMA SHUNT_BAERVELDT. SECTION D4 - CATALOG #: UNK_GLAUCOMA SHUNT_BAERVELDT. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN/NO INFORMATION. EXPIRATION DATE: UNKNOWN DUE TO THE SERIAL# IS NOT PROVIDED. UNIQUE IDENTIFIER NUMBER: UNKNOWN DUE TO THE SERIAL# IS NOT PROVIDED. IF IMPLANTED; GIVE DATE: UNKNOWN/NO INFORMATION. IF EXPLANTED; GIVE DATE: UNKNOWN/NO INFORMATION. TELEPHONE NUMBER: (B)(6). DEVICE MANUFACTURE DATE: UNKNOWN DUE TO THE SERIAL# IS NOT PROVIDED. THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THERE WAS A PARTIAL MODEL NUMBER PROVIDED AND NO SERIAL NUMBER REPORTED FOR THIS DEVICE. THEREFORE, NO FURTHER INVESTIGATION CAN BE PERFORMED. IF THERE IS ANY FURTHER RELEVANT INFORMATION A SUPPLEMENTAL MEDWATCH WILL BE FILED. ATTEMPTS HAVE BEEN MADE TO OBTAIN MISSING INFORMATION; HOWEVER, TO DATE, NO RESPONSE HAS BEEN RECEIVED. CITATION: SWAMINATHAN, S. S., QUIST, M. S., DAWSON, L. E., ROTHMAN, A. L., AND HERNDON, L. W. (2020) EFFECT OF NYLON WICK TECHNIQUE ON EARLY INTRAOCULAR PRESSURE CONTROL IN NON-VALVED AQUEOUS SHUNT SURGERY. JOURNAL OF GLAUCOMA PUBLISH AHEAD OF PRINT DOI:10.1097/IJG.0000000000001674. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    THE FOLLOWING ARTICLE WAS RECEIVED BASED ON A LITERATURE REVIEW. EFFECT OF NYLON WICK TECHNIQUE ON EARLY INTRAOCULAR PRESSURE CONTROL IN NONVALVED AQUEOUS SHUNT SURGERY. A RETROSPECTIVE STUDY WAS DONE TO COMPARE EARLY POSTOPERATIVE INTRAOCULAR PRESSURE (IOP) AND MEDICATION USAGE IN PATIENTS UNDERGOING IMPLANTATION OF A NON-VALVED AQUEOUS SHUNT DEVICE WITH FENESTRATIONS ONLY OR FENESTRATIONS WITH NYLON WICKS. A TOTAL OF 92 EYES OF 92 PATIENTS WITH GLAUCOMA RECEIVED FENESTRATIONS WITH NYLON WICKS WERE INCLUDED IN THE STUDY. THESE PATIENTS WERE EITHER IMPLANTED WITH A BAERVELDT 350 MM2 (N=56) (JOHNSON & JOHNSON VISION) OR CLEARPATH 350 MM2 (N=36) IMPLANT. IN ADDITION, A 6-0 PROLENE (ETHICON) OR NYLON SUTURE WAS USED AS A RIPCORD PER THE SURGEON¿S DISCRETION BACKLOADED INTO THE BAERVELDT IMPLANT AND SECURED USING A 7-0 VICRYL (POLYGLACTIN) SUTURE APPROXIMATELY 2MM ANTERIOR TO THE PLATE. THE CONJUNCTIVAL INCISION WAS CLOSED WITH BOTH INTERRUPTED AND RUNNING 8-0 VICRYL SUTURE (ETHICON). POST-OPERATIVE COMPLICATIONS INCLUDE PULLED RIPCORD (N=24), HYPOTONY (N=30), WOUND DEHISCENCE OR LEAK (N=8), HYPHEMA (N=26), ELEVATED INTRAOCULAR PRESSURE (IOP) REQUIRING ¿BURP¿ (N=3), AND ANTERIOR CHAMBER (AC) REFORMATION (N=3). FIVE PATIENTS REQUIRED ADDITIONAL SURGERIES WHICH INCLUDE ANTERIOR CHAMBER WASHOUTS (N=2), TUBE REPOSITIONING DUE TO OCCLUSION OF THE TUBE BY IRIS (N=1), REPAIR OF A WOUND LEAK (N=1), AND RETYING OF A LOOSE LIGATURE SUTURE (N=1). OTHER JNJ PRODUCTS WERE MENTIONED BUT IT IS NOT CLEAR TO WHICH DEVICE THE COMPLAINTS ARE RELATED TO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    905280 BAERVELDT GLAUCOMA IMPLANT GLAUCOMA IMPLANT KYF AMO MANUFACTURING NETHERLANDS UNK_GLAUCOMA SHUNT_BAERVELDT

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention PROLENE AND VICRYL SUTURES