BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALYTE¿ Y-MESH GRAFT

    MDR report key: 8223171 · Received January 7, 2019

    Report

    Report Number
    1018233-2019-00127
    Event Type
    Injury
    Date Received
    January 7, 2019
    Date of Event
    April 24, 2018
    Report Date
    March 29, 2019
    Manufacturer
    C.R. BARD, INC. (COVINGTON) -1018233
    Product Code
    OTO
    PMA / PMN Number
    K101722
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE LOT NUMBER IS UNKNOWN THEREFORE THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED. THE INSTRUCTIONS FOR USE WERE FOUND ADEQUATE AND STATE THE FOLLOWING: ¿CAUTION: FEDERAL (USA) LAW RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN. THE ALYTE¿ Y-MESH GRAFT IS INTENDED FOR USE ONLY BY PHYSICIANS WHO ARE TRAINED IN THE SURGICAL PROCEDURES AND TECHNIQUES REQUIRED FOR PELVIC FL OOR RECONSTRUCTION AND THE IMPLANTATION OF NON-ABSORBABLE MESHES. THE PHYSICIAN IS ADVISED TO CONSULT THE MEDICAL LITERATURE REGARDING TECHNIQUES, COMPLICATIONS, AND HAZARDS ASSOCIATED WITH THE INTENDED PROCEDURES. DESCRIPTION THE ALYTE¿ Y-MESH GRAFT UTILIZES A VARIABLE KNIT LIGHTWEIGHT/ULTRA-LIGHTWEIGHT NON-ABSORBABLE MONOFI LAMENT POLYPROPYLENE MESH. THE Y-MESH CONFI GURATION IS DESIGNED SUCH THAT THE SURGEON WILL BE ABLE TO ALTER/TRIM THE GRAFT TO DIFFERENT SIZES AS REQUIRED TO FI T EACH PATIENT¿S ANATOMICAL REQUIREMENTS WITHOUT UNRAVELING. INDICATIONS FOR USE THE ALYTE¿ Y-MESH GRAFT IS INDICATED FOR TISSUE REINFORCEMENT AND LONG-LASTING STABILIZATION OF FASCIAL STRUCTURES OF THE PELVIC FL OOR IN VAGINAL WALL PROLAPSE INCLUDING, BUT NOT LIMITED TO SACROCOLPOSUSPENSION WHERE SURGICAL TREATMENT IS INTENDED, EITHER AS MECHANICAL SUPPORT OR BRIDGING MATERIAL FOR THE FASCIAL DEFECT. CONTRAINDICATIONS THE USE OF THE ALYTE¿ Y-MESH GRAFT IS CONTRAINDICATED FOR PATIENTS WHO ARE PREGNANT OR MAY BECOME PREGNANT, OR THOSE WITH A SYSTEMIC INFECTION OR INFECTION IN THE OPERATIVE FI ELD. WARNINGS ¿ THE IMPLANT PROCEDURE CARRIES AN INHERENT RISK OF INFECTION AND BLEEDING, AS DO SIMILAR UROLOGICAL PROCEDURES. ¿ AFTER USE, THE PRODUCT AND ITS PACKAGING SHOULD BE TREATED AS A POTENTIAL BIOHAZARD. HANDLE AND DISPOSE OF IN ACCORDANCE WITH ACCEPTED MEDICAL PRACTICE AND APPLICABLE LOCAL, STATE, AND FEDERAL LAWS AND REGULATIONS. PRECAUTIONS ¿ THE ALYTE¿ Y-MESH GRAFT HAS NOT BEEN EVALUATED IN HUMAN SUBJECTS FOR THE TREATMENT OF VAGINAL WALL PROLAPSE. ¿ BASED ON PHYSICIAN EXPERIENCE AND TRAINING, A THOROUGH ASSESSMENT OF EACH PATIENT SHOULD BE MADE TO DETERMINE THEIR SUITABILITY FOR A SYNTHETIC MESH PROCEDURE. ADDITIONAL CONSIDERATION SHOULD BE GIVEN TO THE USE OF ALYTE¿ Y-MESH GRAFT IN PATIENTS WITH A COMPROMISED IMMUNE SYSTEM, ANY CONDITION THAT WOULD COMPROMISE HEALING, OR ANY PATIENT WITH A HISTORY OF PRIOR ABDOMINAL OR PELVIC SURGERIES. CONSIDERATION SHOULD ALSO BE GIVEN TO THE ABILITY OF THE PATIENT TO TOLERATE THE SURGICAL PROCEDURE. ¿ ACCEPTED SURGICAL PRACTICE AND PRECAUTIONS MUST BE FOLLOWED FOR THE MANAGEMENT OF INFECTED OR CONTAMINATED WOUNDS. ¿ POSTOPERATIVE BLEEDING MAY OCCUR IN SOME PATIENTS AND MUST BE CONTROLLED PRIOR TO PATIENT RELEASE. ¿ SUTURES SHOULD NOT BE PLACED IN THE MESH EDGE. SUTURES SHOULD BE PLACED A MINIMUM OF 1CM FROM ANY MESH EDGE. ¿ INADEQUATE SUTURING OF THE GRAFT MATERIAL TO THE PELVIC TISSUES MAY LEAD TO FAILURE OF THE REPAIR, ADDITIONAL COMPLICATIONS AND RECURRENCE OF PROLAPSE. ¿ CHECK THE INTEGRITY OF THE PACKAGING BEFORE USE. DO NOT USE THE MESH IF THE PACKAGING IS OPENED OR DAMAGED. ¿ AS FOR ANY IMPLANTABLE MATERIAL, IT IS RECOMMENDED TO OPEN THE PACKAGE AT THE TIME OF IMPLANTATION." PATIENT CODE:(B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE VAGINAL MESH WAS EXPOSED FOLLOWING THE LAPAROSCOPIC MESH SACROCOLPOPEXY PROCEDURE. THERE WAS NO EVIDENCE OF A DEFECTIVE DEVICE ONLY COMPLICATION OF PROCEDURE. ALLEGEDLY, THE PATIENT EXPERIENCED DISCHARGE AND PAINFUL INTERCOURSE, AS A RESULT OF THE MESH EXPOSURE. PATIENT HAS UNDER GONE A PARTIAL SURGICAL EXCISION OF THE MESH IMPLANT. THERE WAS NO OTHER MEDICAL INTERVENTION REPORTED.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. THE DEVICE WAS NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VAGINAL MESH WAS EXPOSED FOLLOWING THE LAPAROSCOPIC MESH SACROCOLPOPEXY PROCEDURE. THERE WAS NO EVIDENCE OF A DEFECTIVE DEVICE, ONLY COMPLICATION OF PROCEDURE. ALLEGEDLY, THE PATIENT EXPERIENCED DISCHARGE AND PAINFUL INTERCOURSE, AS A RESULT OF THE MESH EXPOSURE. PATIENT HAS UNDER GONE A PARTIAL SURGICAL EXCISION OF THE MESH IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    16674 ALYTE¿ Y-MESH GRAFT ALYTE Y-MESH GRAFT OTO C.R. BARD, INC. (COVINGTON) -1018233 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention