BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVAULTA PLUS SYNTHETIC SUPPORT SYSTEM

    MDR report key: 2230530 · Received August 12, 2011

    Report

    Report Number
    1018233-2011-00188
    Event Type
    Injury
    Date Received
    August 12, 2011
    Report Date
    November 12, 2015
    Manufacturer
    C.R. BARD, INC.
    Product Code
    FTL
    PMA / PMN Number
    K063712
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    NOT APPLICABLE
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE REMAINED IMPLANTED. THE DEVICE HISTORY RECORD WAS REVIEWED FINDING NOTHING THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE INSTRUCTIONS FOR USE WHICH ACCOMPANIES EACH DEVICE STATES IN THE ADVERSE REACTIONS SECTION: "POTENTIAL ADVERSE REACTIONS ARE THOSE TYPICALLY ASSOCIATED WITH SURGICALLY IMPLANTABLE MATERIALS, INCLUDING HEMATOMA, SEROMA, MOCISAL OR VISCERAL EROSION, INFECTION, INFLAMMATION, SENSITIZATION, DYSPAREUNIA, SCARIFICATION AND CONTRACTION, FISTULA FORMATION, EXTRUSION AND RECURRENCE OF VAGINAL WALL PROLAPSE. PERFORATIONS OR LACERATIONS OF VESSELS, NERVES, BLADDER, BOWEL, RECTUM, OR ANY VISCERA MAY OCCUR DURING NEEDLE PASSAGE." ACCORDING TO THE MEDICAL RECORDS PROVIDED TO BARD ON JULY 20, 2010, A (B)(6) FEMALE PT, WITH A SIGNIFICANT HISTORY OF SMOKING, EXCESSIVE MENSTRUATION, 2ND DEGREE UTERO-VAGINAL PROLAPSE, AND MIXED INCONTINENCE, WENT INTO SURGERY FOR A LAPAROSCOPIC SUPRACERVICAL HYSTERECTOMY, ANTERIOR REPAIR OF A CYSTOCELE WITH MESH INSERTION, AND A POSTERIOR REPAIR. DURING THE LAPAROSCOPIC SUPRACERVICAL HYSTERECTOMY, THE MEDICAL RECORDS INDICATE THE VAGINAL AND UTERO-OVARIAN LIGAMENTS WERE CUT. (THE RECORDS DID NOT STATE WHETHER OR NOT THEY WERE SUTURED BACK TO PREVENT FUTURE PROLAPSE). WHEN THE INCISIONS WERE MADE THROUGH THE VAGINA FOR MESH PLACEMENT, THE RECORDS NOTED THAT A 1CM INCISION WAS PLACED INFERIOR TO THE INSERTION OF THE ADDUCTOR LONGUS LATERAL TO THE CLITORIS AND ANOTHER WAS MADE APPROX 4 INCHES BELOW IN THE OBTURATOR FOSSA. THE ANTERIOR WALL PROLAPSE WAS REPAIRED USING AN AVAULTA PLUS MESH. IT WAS STATED BY THE PHYSICIAN THAT DUE TO MULTIPLE DENSE ADHESIONS FROM PREVIOUS POSTERIOR VAGINAL SURGERIES AND THE CLOSE PROXIMITY OF THE RECTUM TO THE VAGINAL MUCOSA, THAT A POSTERIOR MESH WOULD NOT BE APPROPRIATE FOR PLACEMENT AND SUTURES WERE USED TO REDUCE THE BULGE OF THE RECTOCELE. THE PT EXPERIENCED MENORRHAGIA, CYSTOCELE PRIOR TO THE MESH PLACEMENT. THESE SYMPTOMS WERE ALSO PRESENT AFTER THE MESH PLACEMENT. IF ADD'L MEDICAL RECORDS ARE MADE AVAILABLE, THIS MEDICAL RECORD REVIEW WILL BE UPDATED AT THAT TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PT'S ATTORNEY THAT AS A RESULT OF HAVING THE PRODUCT (S) IMPLANTED, THE PT HAS EXPERIENCED SIGNIFICANT MENTAL AND PHYSICAL PAIN AND SUFFERING, HAS SUSTAINED PERMANENT INJURY, AND PERMANENT AND SUBSTANTIAL PHYSICAL DEFORMITY, AND HAS UNDERGONE OR WILL UNDERGO CORRECTIVE SURGERY OR SURGERIES. THE PT HAS EXPERIENCED BLEEDING, INFECTIONS, INTENSE PAIN AND SURGERY TO ADJUST THE MESH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AVAULTA PLUS SYNTHETIC SUPPORT SYSTEM FTL FTL C.R. BARD, INC. NA CVSI0010

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Female Required Intervention CYSTOSCOPY| LAPAROSCOPIC SUPRACERVICAL HYSTERECTOMY| POSTERIOR REPAIR| CYSTOSCOPY| LAPAROSCOPIC SUPRACERVICAL HYSTERECTOMY| POSTERIOR REPAIR