BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UPHOLD VAGINAL SUPPORT SYSTEM

    MDR report key: 3143414 · Received June 3, 2013

    Report

    Report Number
    3005099803-2013-04374
    Event Type
    Injury
    Date Received
    June 3, 2013
    Report Date
    May 7, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    FTL
    PMA / PMN Number
    K081048
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CASE REPORT: "EARLY AND COMPLETE EXCISION OF VAGINALLY PLACED SYNTHETIC MESH" - SHERIF A. EL-NASHAR, MBBCH, MS, SHUNAHA KIM-FINE, MD, AND EMANUEL C. TRABUCO, MD, MS. - FEMALE PELVIC MEDICINE & RECONSTRUCTIVE SURGERY & VOLUME 19, NUMBER 3, MAY/JUNE 2013.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT IN (B)(6) 2011, THE PATIENT UNDERWENT AN ANTERIOR UPHOLD WITH UTERINE PRESERVATION PROCEDURE. POSTOPERATIVELY, THE PATIENT HAD IMMEDIATE, SEVERE PAIN, FREQUENCY, URGENCY, AND URINARY RETENTION. REPORTEDLY, POST-PROCEDURE, THE PATIENT¿S POST-OPERATIVE PAIN WAS DESCRIBED AS CONTINUOUS PRESSURE AND DISCOMFORT IN THE BUTTOCK AREA, WHICH SHE RATED FROM 3 TO 4 OF 10 AT REST. REPORTEDLY, THE PAIN INCREASED IN BOTH SITTING AND STANDING POSITIONS, AND IMPROVED WHEN LYING DOWN. PAIN WAS RELIEVED ONLY WITH NARCOTIC PAIN MEDICATION. THE PATIENT WAS GIVEN AN ABDOMINAL EXAMINATION WHICH WAS NORMAL, AND A LIMITED PELVIC EXAM SHOWED NO EVIDENCE OF MESH EROSION, INFECTION, OR HEMATOMA AND SHE HAD AN INTACT SUTURE LINE. THE MESH LEGS WERE PROMINENTLY FELT IN THE VAGINAL GUTTERS BILATERALLY, AND WERE TENDER TO PALPATION. THE PATIENT WAS GIVEN THE OPTION OF PAIN MANAGEMENT WITH LOCAL AND SYSTEMIC ANALGESIA OR SURGICAL REMOVAL, AND SHE CHOSE REMOVAL. ELEVEN DAYS POST IMPLANT, THE PATIENT WAS TAKEN TO THE OPERATING ROOM FOR SURGICAL MESH REMOVAL. EXAMINATION UNDER ANESTHESIA REVEALED AN INTACT INCISION LINE WITH NO EVIDENCE OF MESH EROSION OR INFECTION. THERE WAS A NOTICEABLE BANDING OF THE MESH LEGS IN THE GUTTERS BILATERALLY. IT APPEARED THE RIGHT SIDE OF THE MESH HAD TWISTED ON ITSELF. THE ENTIRE MESH IMPLANT WAS SUCCESSFULLY EXCISED. PATIENT REPORTED RESOLUTION OF PAIN AND URINARY SYMPTOMS IN THE IMMEDIATE POST-OPERATIVE PERIOD AND WAS DISCHARGED ON POSTOPERATIVE DAY 1. TWO WEEKS AFTER THE EXCISION SURGERY, THE PATIENT WAS READMITTED WITH ACUTE VAGINAL BLEEDING THAT REQUIRED HEMOSTATIC SUTURING, VAGINAL PACKING AND A BLOOD TRANSFUSION. THE PATIENT WAS OBSERVED FOR 23 HOURS AND DISCHARGED WITHOUT FURTHER ISSUES. THE PATIENT CONTINUED TO BE PAIN FREE AT 6 AND 12 WEEKS, AND DID NOT HAVE SIGNIFICANT ANTERIOR OR APICAL VAGINAL WALL PROLAPSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    244748 UPHOLD VAGINAL SUPPORT SYSTEM MESH, SURGICAL, POLYMERIC FTL BOSTON SCIENTIFIC - MARLBOROUGH M0068317080

    Patients

    Seq Age Sex Outcome Treatment
    1 37 Hospitalization| R