BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BAERVELDT SHUNT

    MDR report key: 14994208 · Received July 12, 2022

    Report

    Report Number
    3012236936-2022-01822
    Event Type
    Injury
    Date Received
    July 12, 2022
    Report Date
    June 19, 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

    AGE: 0-5 (YRS): 37 (49%); 6-10 (YRS):16 (21%); 11+ (YRS): 23 (30%) GENDER: MALE: 41 (54%); FEMALE: 35 (46%) WEIGHT: INFORMATION UNKNOWN/NOT PROVIDED. ETHNICITY: CAUCASIAN: 52 (68%); NON-CAUCASIAN: 24 (32%) RACE: INFORMATION UNKNOWN/NOT PROVIDED. DATE OF EVENT: UNKNOWN, NOT PROVIDED. SERIAL NUMBER: UNKNOWN, INFORMATION NOT PROVIDED. A COMPLETE CATALOG NUMBER IS UNKNOWN AS THE SERIAL NUMBER WAS NOT PROVIDED. EXPIRATION DATE: UNKNOWN, AS THE SERIAL NUMBER WAS NOT PROVIDED. UDI NUMBER: UDI NUMBER IS UNKNOWN, AS THE SERIAL NUMBER WAS NOT PROVIDED. IMPLANT DATE: UNKNOWN, INFORMATION NOT PROVIDED. EXPLANT DATE: NOT APPLICABLE, AS THERE IS NO INDICATION THAT THE DEVICE WAS EXPLANTED. THE DEVICE WAS NOT RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE CANNOT BE COMPLETED. AS THE SERIAL NUMBER OF THE DEVICE IS UNKNOWN NO FURTHER INVESTIGATION CAN BE PERFORMED. IF THERE IS ANY RELEVANT INFORMATION RECEIVED, A SUPPLEMENTAL MEDWATCH WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN, AS THE SERIAL NUMBER WAS NOT PROVIDED. CITATION: JACOBSON, ADAM MD; BESIRLI, CAGRI G. MD, PHD; BOHNSACK, BRENDA L. MD, PHD. OUTCOMES OF BAERVELDT GLAUCOMA DRAINAGE DEVICES IN PEDIATRIC EYES, JOURNAL OF GLAUCOMA: JUNE 2022 - VOLUME 31 - ISSUE 6 - PP.468-477 DOI: 10.1097/IJG.0000000000001970. ATTEMPTS HAVE BEEN MADE TO OBTAIN THE MISSING INFORMATION; HOWEVER, TO DATE, NO RESPONSE HAS BEEN RECEIVED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: IN THE REPORT SUBMITTED JULY 12, 2022 ((B)(4)), AN INCORRECT CATALOG NUMBER WAS INADVERTENTLY SUBMITTED. THIS REPORT CONTAINS THE CORRECTED CATALOG NUMBER. SECTION D4 - CATALOG #: 23030817. 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 A LITERATURE REVIEW: ARTICLE: OUTCOMES OF BAERVELDT GLAUCOMA DRAINAGE DEVICES IN PEDIATRIC EYES. A RETROSPECTIVE STUDY WAS DONE TO EVALUATE THE SUCCESS AND RISK FACTORS FOR FAILURE AND COMPLICATIONS OF BAERVELDT GLAUCOMA IMPLANTS IN CHILDREN. A TOTAL OF 106 EYES OF 76 PATIENTS UNDERWENT 110 BAERVELDT PLACEMENT (101-350 OR 101-250; ABBOTT MEDICAL OPTICS). FORTY OF 110 SURGERIES (N=40) WERE CONSIDERED AS FAILURES AT FINAL FOLLOW-UP. THIS INCLUDED 14 PROCEDURES IN 13 EYES WHICH SUFFERED POSTOPERATIVE COMPLICATIONS WHICH INCLUDE RETINAL DETACHMENT (N=7 EYES), HYPOTONY REQUIRING SURGERY (N=4 EYES), SUPRACHOROIDAL HEMORRHAGE (N=1 EYE), KERATOPROSTHESIS EXTRUSION (N=1 EYE), AND VITREOUS HEMORRHAGE (N=1 EYE). TWENTY-SIX OF THESE FAILED BAERVELDT PROCEDURES WERE DUE TO NEED FOR AT LEAST 1 ADDITIONAL SURGERY FOR INCREASED IOP (N=26). ADDITIONALLY, IT WAS REPORTED THAT THERE WERE 4 EYES WITH NO LIGHT PERCEPTION. POST-BAERVELDT GLAUCOMA RELATED SURGERIES (TREATMENT) INCLUDE TUBE REVISION FOR INCREASED IOP (N=6 EYES), TUBE LIGATION FOR HYPOTONY OR RETINAL DETACHMENT (N=8 EYES), TUBE SHORTENING (N=9 EYES), CONTACT TRANSCLERAL (N=15 EYES), ENDOSCOPIC SURGERY (N=5 EYES), TRABECULECTOMY WITH MITOMYCIN C (N=1 EYE), OLOGEN-AUGMENTED AHMED FP7 PLACEMENT (N=1 EYE), GONIOTOMY (N=1 EYE), AND SCLERAL WINDOWS (N=1 EYE). POST-BAERVELDT NON-GLAUCOMA RELATED SURGERIES INCLUDE LENSECTOMY (N=8 EYES), CAPSULOTOMY (N=5 EYES), PARS PLANA VITRECTOMY (N=5 EYES), KERATOPLASTY (PENETRATING OR PARTIAL THICKNESS) (N=4 EYES), SUPERFICIAL KERATECTOMY (N=3 EYES), AND SECONDARY INTRAOCULAR LENS PLACEMENT (N=3 EYES). OTHER JNJ PRODUCTS WERE MENTIONED BUT NO COMPLAINTS WERE REPORTED AGAINST THEM. THIS REPORT IS FOR THE BAERVELDT DEVICE BG101-350. A SEPARATE REPORT WILL BE SUBMITTED FOR THE OTHER BAERVELDT DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    771752 BAERVELDT SHUNT IMPLANT, EYE VALVE KYF AMO MANUFACTURING NETHERLANDS BG101-350

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention