BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK_GLAUCOMA SHUNT_BAERVELDT SHUNT

    MDR report key: 19945769 · Received August 8, 2024

    Report

    Report Number
    3012236936-2024-000220
    Event Type
    Injury
    Date Received
    August 8, 2024
    Report Date
    August 8, 2024
    Manufacturer
    AMO MANUFACTURING NETHERLANDS
    Product Code
    KYF
    PMA / PMN Number
    K905129
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION A2: AGE / DATE OF BIRTH: 68.6 ± 14.5. SECTION A3A: GENDER: FEMALE N (%): 27 (45.0). SECTION A3B: UNKNOWN/ NOT PROVIDED. SECTION A4: WEIGHT: UNKNOWN/ NOT PROVIDED. SECTION A5: ETHNICITY N (%): HISPANIC 1(1.7). SECTION A6: RACE N (%): WHITE: 23 (38.3), BLACK 18 (30.0), HISPANIC 1(1.7), INDIAN 1(1.7), UNKNOWN/OTHERS 17 (28.3). SECTION B3: DATE OF EVENT: UNKNOWN, NOT PROVIDED. HOWEVER, ACCEPTED DATE STATED DECEMBER 22, 2023. SECTION D4: MODEL NUMBER: UNKNOWN, BUT PARTIAL MODEL BGI-250 PROVIDED. SECTION D4: CATALOG NUMBER: UNKNOWN, BUT ONLY PARTIAL CATALOG NUMBER WAS PROVIDED AS SERIAL NUMBER NOT PROVIDED. SECTION D4: UDI NUMBER: UNKNOWN, BUT ONLY PARTIAL NUMBER PROVIDED. SECTION H3- NO: THE DEVICE WAS NOT RETURNED FOR EVALUATION AND THE SERIAL NUMBER FOR THIS DEVICE IS UNKNOWN/NOT PROVIDED; THEREFORE, NO FURTHER PRODUCT INVESTIGATION CAN BE PERFORMED. SHOULD ANY FURTHER RELEVANT INFORMATION BECOME AVAILABLE A SUPPLEMENTAL MEDWATCH WILL BE FILED. SECTION H4: DEVICE MANUFACTURE DATE: UNKNOWN, AS THE SERIAL NUMBER WAS NOT PROVIDED. SECTION H6: HEALTH EFFECT-IMPACT CODE: 4625 (TO CAPTURE SECONDARY SURGICAL INTERVENTION: SURGICAL INTERVENTION AND YAG). SECTION H6: HEALTH EFFECT-CLINICAL CODE: 4468 (TO CAPTURE HYPOTONY- TRANSIENT AND PERSISTENT. SECTION H6: HEALTH EFFECT-CLINICAL CODE: 2138 (TO CAPTURE VISION LOSS AND DIPLOPIA-PERSISTENT). CITATION: SHALABY WS, REDDY R, WUMMER B, HUANG P, LEE D, RAZEGHINEJAD R, PRO MJ. AHMED CLEARPATH VS. BAERVELDT GLAUCOMA IMPLANT: A RETROSPECTIVE NONINFERIORITY COMPARATIVE STUDY. OPHTHALMOL GLAUCOMA. 2024: PP.1-9 HTTPS://DOI.ORG/10.1016/J.OGLA.2023.12.006. ISSN 2589-4196/24. ATTEMPTS HAVE BEEN MADE TO OBTAIN MISSING INFORMATION; HOWEVER, NO RESPONSE HAS BEEN RECEIVED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    THE FOLLOWING ARTICLE WAS RECEIVED BASED ON LITERATURE REVIEW. ARTICLE: AHMED CLEARPATH VS. BAERVELDT GLAUCOMA IMPLANT: A RETROSPECTIVE NONINFERIORITY COMPARATIVE STUDY. A SINGLE-CENTER, RETROSPECTIVE, COMPARATIVE STUDY WAS DONE TO COMPARE THE EFFICACY AND SAFETY OF 2 NONVALVED GLAUCOMA DRAINAGE DEVICES (GDDS): AHMED CLEARPATH (ACP) VS. BAERVELDT GLAUCOMA IMPLANT (BGI). A TOTAL OF 128 EYES OF 113 PATIENTS WITH GLAUCOMA WERE INCLUDED IN THE STUDY: 63 EYES UNDERWENT ACP (AGV; NEW WORLD MEDICAL INC) IMPLANTATION AND 65 EYES UNDERWENT BGI IMPLANTATION (BGI; ADVANCED MEDICAL OPTICS). TWENTY-ONE EYES WERE IMPLANTED WITH THE 250MM2 PLATE WHILE 44 EYES WERE IMPLANTED WITH THE 350 MM2 PLATE. IT WAS REPORTED THAT 3 EYES MET THE FAILURE CRITERIA BY THE END OF FOLLOW-UP IN THE BGI GROUP DUE TO ELEVATED INTRAOCULAR PRESSURE (IOP) > 21 MMHG. IT WAS REPORTED THAT THERE WAS A BCVA DECLINE > 2 SNELLEN LINES IN 23.1% OF BGI EYES BY THE END OF FOLLOW-UP. IN THE BGI GROUP, POSTOPERATIVE COMPLICATIONS REPORTED INCLUDE DIPLOPIA (N=5 EYES), TRANSIENT HYPOTONY (N=7 EYES), PERSISTENT HYPOTONY (N=1 EYE) THAT LED TO EITHER HYPOTONY MACULOPATHY OR SEROUS RETINAL DETACHMENT, CHOROIDAL EFFUSION (N=9 EYES), SUPRACHOROIDAL HEMORRHAGE (N=1 EYE), RECURRENT TUBE EROSION (N=1 EYE), AND TUBE BLOCKAGE (N=1 EYE). INTERVENTIONS REPORTED INCLUDE CONSERVATIVE TREATMENT WITH PRISMS (N=3 EYES), CONSERVATIVE TREATMENT (N=7 EYES), TUBE REVISION (N=5 EYES), STRABISMUS SURGERY (N=1 EYE), ANTERIOR CHAMBER (AC) REFORMATION (N=5 EYES), TUBE REMOVAL (N=1 EYE), SURGICAL DRAINAGE (N=3 EYES), AND YAG LASER (N=1 EYE). OTHER COMPLICATIONS INCLUDED HYPHEMA THAT REQUIRED SURGICAL WASHOUT (N=1 EYE), INTRAOCULAR LENS DISLOCATION WITH VITREOUS PROLAPSE OCCLUDING THE TUBE THAT REQUIRED LENS REPOSITION AND ANTERIOR VITRECTOMY (N=1 EYE), RETINAL TEAR THAT REQUIRED LASER RETINOPEXY (N=1 EYE), AND VITREOUS HEMORRHAGE THAT WAS PROBABLY DUE TO RETINAL VEIN OCCLUSION (N=1 EYE). IT IS NOT CLEAR IF THESE COMPLICATIONS OCCURRED IN THE EYES IMPLANTED WITH THE BGI OR THE OTHER PRODUCT. OTHER JNJ PRODUCTS WERE MENTIONED BUT NO COMPLAINTS WERE REPORTED AGAINST THEM. A COPY OF THE ARTICLE IS PROVIDED WITH THIS REPORT. THIS REPORT IS FOR SUSPECT DEVICE, MODEL BGI-250MM ADVERSE EVENT ISSUES. SEPARATE REPORTS ARE BEING SUBMITTED TO CAPTURE THE ADVERSE EVENT ISSUES FOR SUSPECT DEVICE, MODEL BGI-350MM, PRODUCT PROBLEM ISSUES FOR SUSPECT DEVICE, MODEL BGI-350MM AND PRODUCT PROBLEM ISSUES FOR SUSPECT DEVICE, MODEL BGI-250MM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1562351 UNK_GLAUCOMA SHUNT_BAERVELDT SHUNT IMPLANT, EYE VALVE KYF AMO MANUFACTURING NETHERLANDS UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention