BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BAERVELDT SHUNT

    MDR report key: 14993793 · Received July 12, 2022

    Report

    Report Number
    3012236936-2022-01842
    Event Type
    Malfunction
    Date Received
    July 12, 2022
    Report Date
    July 27, 2022
    Manufacturer
    AMO MANUFACTURING NETHERLANDS
    Product Code
    KYF
    PMA / PMN Number
    K955455
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AGE/DATE OF BIRTH: EXACT AGE NOT PROVIDED, MEAN AGE WAS 73.0 ± 13.3. SEX/GENDER: MALE 36 (50.7%), FEMALE 35 (49.3%). RACE/ETHNICITY: AFRICAN AMERICAN 18 (25.4), CAUCASIAN 49 (69.0), HISPANIC 1 (1.4), OTHER 3 (4.2). DATE OF EVENT: JANUARY¿APRIL 2021 (THE DATE ARTICLE WAS PUBLISHED). MODEL NUMBER: UNKNOWN, AS THE SERIAL NUMBER WAS NOT PROVIDED, ONLY PROVIDED AS (B)(4). IF IMPLANTED; GIVE DATE: UNKNOWN/NOT PROVIDED. ONLY PROVIDED AS OVER 4 YEARS (SEPTEMBER 2012 TO NOVEMBER 2016). IF EXPLANTED; GIVE DATE: N/A (NOT APPLICABLE) THERE IS NO INDICATION THE DEVICE HAS BEEN EXPLANTED. THE DEVICE WAS NOT RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE CANNOT BE COMPLETED. A REVIEW OF THE DEVICE HISTORY RECORD, COMPLAINT TRENDING, AND RISK DOCUMENTATION FOR THIS DEVICE WILL BE PERFORMED. UPON COMPLETION OF THE REVIEW, IF THERE IS ANY FURTHER RELEVANT INFORMATION A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4). ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION RECEIVED THAT THE DOCTOR WAS PRETTY CONFIDENT THAT THE BAERVELDT'S 350 WERE USED, HOWEVER, DID NOT PROVIDE THE EXACT MODEL. THE DOCTOR ALSO INDICATED THAT THE STUDY WAS MOST INTERESTED IN THE EFFICACY OF THE PATCH GRAFTS AND THAT THE ADVERSE EVENTS WERE NOT INTERPRETED TO BE FAULT OF THE DEVICES AND LIKEWISE A TUBE BLOCKAGE OR MAL POSITION WOULD NOT BE THE FAULT OF THE TUBE, BUT OF SURGERY OR PATIENT OR DISEASE. NO OTHER INFORMATION WAS PROVIDED. 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: COMPARISON OF LOCALLY SOURCED PERICARDIUM AND OTHER CONVENTIONAL PATCH GRAFT MATERIALS IN A GLAUCOMA DRAINAGE DEVICE SURGERY THIS RETROSPECTIVE, OBSERVATIONAL STUDY WAS DONE TO COMPARE THE OUTCOMES AND COSTS OF VARIOUS PATCH GRAFT MATERIALS USED IN THE SETTING OF GLAUCOMA DRAINAGE DEVICE (GDD) SURGERIES: CONVENTIONAL TUTOPLAST® PERICARDIUM (TP), LOCALLY OBTAINED LIFENET® PERICARDIUM (LP), AND TISSUE-BANKED CORNEAL (CP) AND SCLERAL (SP) PATCHES. A TOTAL OF 185 PATIENTS (N=195 EYES) WERE INCLUDED IN THE STUDY. DRAINAGE DEVICES INCLUDED WERE 132 AHMED GLAUCOMA VALVES (NEW WORLD MEDICINE, INC., RANCHO CUCAMONGA, CA, USA), MODEL FP-7 (N = 127) AND MODEL M4 (N = 5) AND BAERVELDT 350 IMPLANTS (ADVANCED MEDICAL OPTICS, INC., SANTA ANA, CA, USA) (N=63). PATCH GRAFT MATERIALS INCLUDED CONVENTIONAL IRRADIATED TUTOPLAST® PERICARDIUM (TP) (IOP OPHTHALMICS, COSTA MESA, CA, USA) (N = 43), LOCALLY OBTAINED LIFENET® PERICARDIUM (LP) (LIFENET HEALTH®, VIRGINIA BEACH, VA, USA) (N = 53), TISSUE-BANKED CORNEAL PATCHES (CP) (N = 28), AND SCLERAL PATCHES (SP)(N = 71). COMPLICATIONS INCLUDED CONJUNCTIVAL DEHISCENCE WITHOUT TUBE EXPOSURE OCCURRED IN FOUR EYES (2.1%). THERE WERE SIX TUBE EXPOSURES (3.1%): AHMED FP7 IMPLANTS (N=4 EYES), AND BAERVELDT 350 IMPLANTS (N=2 EYES). OTHER TUBE-RELATED COMPLICATIONS WERE TUBE MALPOSITIONING (1.0%) REQUIRING REPOSITIONING AND ONE TUBE BLOCKAGE (0.5%) REQUIRING TUBE REVISION. IT IS UNCLEAR HOWEVER, IF IT WAS OUR DEVICE OR THE OTHER DEVICES IN THE STUDY THAT WAS IMPLANTED IN THE EYES WITH THESE COMPLICATIONS. THERE WERE NO FURTHER INTERVENTIONS REPORTED. A COPY OF THE ARTICLE IS PROVIDED WITH THIS REPORT. THIS REPORT IS FOR INCOMPLETE MODEL 350MM PRODUCT PROBLEM. A SEPARATE REPORT IS BEING SUBMITTED TO CAPTURE THE REPORTED ADVERSE EVENT FOR THIS MODEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    732667 BAERVELDT SHUNT IMPLANT, EYE VALVE KYF AMO MANUFACTURING NETHERLANDS UNK_GLAUCOMA SHUNT_BAERVELDT

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown