BEUDAMED
    FDA Adverse Event Other Summary report: N

    RESTYLANE INJECTABLE GEL

    MDR report key: 2020390 · Received March 10, 2011

    Report

    Report Number
    2032896-2011-00008
    Event Type
    Other
    Date Received
    March 10, 2011
    Report Date
    February 28, 2011
    Manufacturer
    Q-MED AB
    Product Code
    LMH
    PMA / PMN Number
    P020023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL PMA/510(K)# P040024.

    Description of Event or Problem · 1

    ON (B)(6)-2011, A LITERATURE REPORT FROM (B)(6) WAS RETRIEVED DESCRIBING A (B)(6) FEMALE WHO WAS INJECTED WITH RESTYLANE (CROSS-LINKED HYALURONIC ACID DERMAL FILLER). INOUE K, SATO K, MATSUMOTO D, GONDA K, YOSHIMURA K. ARTERIAL EMBOLIZATION AND SKIN NECROSIS OF THE NASAL ALA FOLLOWING INJECTION OF DERMAL FILLERS. PLAST RECONSTR SURG. 2008;121(3):127E-128E. MEDICAL HISTORY INCLUDED NO PREVIOUS HISTORY OF COSMETIC SURGERY. THE PT'S SKIN TYPE WAS NOT REPORTED. CONCOMITANT MEDICATIONS WERE NOT REPORTED. THE PT RECEIVED AN INJECTION OF RESTYLANE (AMOUNT INJECTED NOT REPORTED) ON AN UNK DATE TO SHAPE THE NASAL TIP CONTOUR. PRE-PROCEDURE MEDICATIONS USED WERE NOT REPORTED. ADDITIONAL PROCEDURES PERFORMED AT THE TIME OF IMPLANTATION INCLUDED AN INJECTION OF HUMAN TISSUE DERIVED RECONSTITUTED COLLAGEN MATRIX, SHEBA (MICRONIZED HUMAN TISSUE), FOR WRINKLE CORRECTION OF THE UPPER WHITE LIP AND NASOLABIAL FOLD AND AUGMENTATION OF THE UPPER VERMILION. ON AN UNK DATE, IMMEDIATELY AFTER THE INJECTION, THE PT HAD A STRIKING PAIN ON THE LEFT SIDE OF HER FACE. A FEW HOURS LATER THE PT NOTICED REDDISH DISCOLORATION FROM THE LEFT SIDE OF THE NOSE AND UPPER LIP TO THE GLABELLAR REGION, WHICH CORRESPONDED TO THE AREA NOURISHED BY THE ANGULAR BRANCH OF THE FACIAL ARTERY. BY THE THIRD DAY OF ONSET, BLISTERS HAD APPEARED AT THE LEFT NASAL ALA. WHEN THE PT CONSULTED THE HOSPITAL ON THE SIXTH DAY, A GANGRENOUS SKIN NECROSIS MEASURING 1 X 1.5 CM WAS PRESENT ON THE LEFT NASAL ALA. THREE-DIMENSIONAL COMPUTED TOMOGRAPHIC ANGIOGRAPHY PERFORMED ON THE NINTH DAY DEMONSTRATED LOCAL OCCLUSION OF THE ANGULAR BRANCH OF THE FACIAL ARTERY AND COMPENSATORY DILATION OF COLLATERAL VESSELS SUCH AS THE INFRAORBITAL ARTERY AND ITS DAUGHTER BRANCHES. INTRAVENOUS ADMINISTRATION OF PROSTANDIN (ALPROSTADIL) 120 UG/DAY WAS THEN STARTED, AND THE SURROUNDING ERYTHEMA DECREASED WITH TIME. THE NECROSIS EXTENDED TO THE SURROUNDING SKIN AND SUBCUTANEOUS TISSUE, AND WAS SURGICALLY REMOVED ON THE TWELFTH DAY. A FULL-THICKNESS SKIN GRAFT TAKEN FROM THE POSTAURICULAR AREA WAS GRAFTED TO THE RESIDUAL SKIN DEFECT ON DAY 43 AND WAS SUCCESSFULLY ACCEPTED. IN THE PRESENT CASE, THE ALAR SKIN RESULTED IN MASSIVE NECROSIS, DESPITE THE ABSENCE OF FILLER INJECTION INTO THE ALA. HISTOPATHOLOGICAL EXAMINATION OF THE BIOPSY SPECIMEN FROM THE NASAL ALA INDICATED INTRA-ARTERIAL AND SUBDERMAL DEPOSITION OF FOREIGN BODIES, ALTHOUGH THE PHYSICIANS COULD NOT IDENTIFY WHETHER THEY WERE RESTYLANE OR SHEBA. SHARP PAIN AND ERYTHEMA IN THE EARLY PHASE SUGGESTED ACUTE AND WIDESPREAD EMBOLIZATION OF THE ARTERY. TOGETHER WITH THE RESULTS OF THE THREE DIMENSIONAL COMPUTED TOMOGRAPHIC ANGIOGRAPHY, THE PHYSICIANS DIAGNOSED THE PT AS HAVING ARTERIAL EMBOLIZATIONS OF THE ANGULAR BRANCH AND ITS DAUGHTER BRANCHES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTYLANE INJECTABLE GEL INJECTABLE DERMAL FILLER LMH Q-MED AB

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Other| R CON MEDS = UNK| PRE MEDS = UNK