BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINIARC SINGLE INCISION SLING SYSTEM

    MDR report key: 3469053 · Received November 6, 2013

    Report

    Report Number
    2183959-2013-01143
    Event Type
    Injury
    Date Received
    November 6, 2013
    Date of Event
    July 1, 2013
    Report Date
    October 28, 2013
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC.
    Product Code
    PAH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SHOULD ADDITIONAL INFO BECOME AVAILABLE REGARDING THIS EVENT IT WILL BE RE-EVALUATED AND A FOLLOW-UP REPORT WILL BE SENT. JOURNAL ARTICLE: SUN, MOU-JONG. "A LIFE-THREATENING HEMATOMA AFTER THE SINGLE-INCISION SLING MINIARC PROCEDURE: A CASE REPORT". JOURNAL OF MINIMALLY INVASIVE GYNECOLOGY. 20.4 (JULY/ AUGUST 2013): 529-532 PRINT.

    Description of Event or Problem · 1

    IT WAS REPORTED IN A JOURNAL ARTICLE THAT A PT WAS IMPLANTED WITH A MINIARC. "THIRTY HOURS AFTER THE OPERATION, THE PT PRESENTED WITH LEFT LOWER QUADRANT ABDOMINAL PAIN AND FULLNESS OF BLADDER. THE PT'S BLOOD PRESSURE DROPPED FROM A PREOPERATIVE READING OF 120/76 MM HG TO 100/65 MM HG WITHOUT AN ACCOMPANYING CHANGE IN HEART RATE, AND URINE OUTPUT WAS MATCHED POSTOPERATIVELY. A PELVIC EXAMINATION REVEALED A HARD SWELLING MASS IN THE LEFT GROIN AREA THAT WAS SUSPICIOUS OF A HEMATOMA. A TRANSABDOMINAL ULTRASONOGRAM REVEALED A 5.3 X 5.4 X 6.5 CM COMPLEX CYSTIC MASS IN THE LEFT PELVIS CONSISTENT WITH A HEMATOMA JUST BELOW THE ABDOMINAL WALL." BECAUSE OF PROGRESSIVE ABDOMINAL PAIN, A SIGNIFICANT DECREASE IN HEMOGLOBIN LEVELS (FROM 14.2 G/DL PREOPERATIVELY TO 9.5 G/DL), AND UNSTABLE VITAL SIGNS (BLOOD PRESSURE DROPPED TO 90/56 MM HG WITH A HIGH PULSE RATE OF 105/MIN), SHE WAS SENT TO THE OPERATING ROOM FOR FURTHER CHECKUP AND HEMATOMA EVACUATION." "BECAUSE ONLY A SMALL AMOUNT OF PINK-COLORED FLUID WAS DRAINED FROM THE INTRAPELVIC DRAINAGE TUBE AND A COMPUTED TOMOGRAPHIC SCAN OF THE PELVIS REVEALED A WELL-DEFINED MARGIN IN THE ASPECT OF THE PELVIS NEAR THE LEFT OBTURATOR FOSSA, AN EXTRAPERITONEAL HEMATOMA" WAS SUSPECTED TO BE CAUSED BY THE "VASCULAR INJURY" DURING THE IMPLANT PROCEDURE. "USING THE TRANSABDOMINAL ULTRASOUND-GUIDED APPROACH, THE VAGINAL CUFF WAS OPENED, KEEPING THE PERITONEUM OF THE VAGINAL PART STILL CLOSED. A LONG SUCTION TUBE WAS INSERTED BENEATH THE BLADDER BASE SPACE REACHING THE HUGE HEMATOMA IN THE EXTRAPERITONEAL OBTURATOR SPACE. AN 800-ML BLOOD CLOT WAS SUCTIONED FROM THE SPACE, AND 2 DRAINAGE TUBES WERE PLACED IN THE RETROPERITONEAL BLADDER BASE. FOUR UNITS OF PACKED RED BLOOD CELLS WERE TRANSFUSED DURING THE OPERATION. ANTIBIOTICS WERE ADMINISTERED TO PREVENT INFECTION. HER ABDOMINAL PAIN WAS GREATLY RELIEVED, AND HER VITAL SIGNS STABILIZED THE FOLLOWING DAY. THE DRAINAGE TUBES WERE REMOVED 2 DAYS LATER. THE PT CONVALESCED WELL 5 DAYS LATER AND WAS DISCHARGED FROM OUR WARD. A SUBSEQUENT ULTRASONOGRAM DURING THE SECOND WEEK REVEALED THAT THE HEMATOMA HAD COMPLETELY RESOLVED. MOREOVER, THE PT REPORTED NO EPISODES OF URINARY INCONTINENCE AT THE 3-MONTH FOLLOW-UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    571303 MINIARC SINGLE INCISION SLING SYSTEM SURGICAL MESH PAH AMERICAN MEDICAL SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Hospitalization| R