BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUPARTZ

    MDR report key: 2854223 · Received November 29, 2012

    Report

    Report Number
    9612392-2012-00015
    Event Type
    Injury
    Date Received
    November 29, 2012
    Report Date
    November 6, 2012
    Manufacturer
    SEIKAGAKU CORPORATION
    Product Code
    MOZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS A DEFINITIVE REPORT. THIS IS A CASE REPORT IN A LITERATURE, BHAGAT R ET AL., PULMONARY EMBOLI FROM THERAPEUTIC SODIUM HYALURONATE, RESPIR CARE, 2012 OCT; (B)(4). OUR MEDICAL ADVISOR'S COMMENT: IT IS UNLIKELY THAT ONLY EXOGENOUS HYALURONAN INJECTED INTO THE JOINT CAN CAUSE AN EMBOLUS AFTER IT TRANSFERRED FROM SYNOVIAL MEMBRANE TO BLOOD STREAM BECAUSE HYALURONAN EXISTS ORIGINALLY IN THE BODY. IT IS DIFFICULT TO DISTINGUISH HYALURONAN FROM ENDOGENOUS ONE BY THE DETECTION METHOD OF HYALURONAN DESCRIBED IN THIS ARTICLE. IN FACT, IT IS NOT CLEAR WHETHER THE DETECTED HYALURONAN IS EXOGENOUS HYALURONAN INJECTED INTO THE KNEE JOINTS OR NOT. ALSO, THE REPORT HAS NOT MADE CLEAR THE PROCESS HOW HYALURONAN INVOLVED WITH THE FORMATION OF EMBOLUS. IT IS RECOMMENDED TO MONITOR THE SIMILAR EVENT CONTINUOUSLY.

    Description of Event or Problem · 1

    ADVERSE EVENT: PULMONARY EMBOLI. UNK - A (B)(6) MALE PATIENT STARTED HIS SECOND COURSE OF SUPARTZ BILATERALLY CONCLUDING A MONTH BEFORE ADMISSION. HE RECEIVED HIS 4TH INJECTION OF SUPARTZ TO THE KNEES. HE WAS ADMITTED TO THE HOSPITAL AFTER WAKING UP AT 3:00 AM WITH SHORTNESS OF BREATH ASSOCIATED WITH SHARP CHEST PAIN RADIATING TO THE RIGHT SHOULDER AND BACK, WHICH WAS MADE WORSE BY DEEP INSPIRATION AND BY COUGHING. UNK - HIS PHYSICAL EXAM WAS UNREMARKABLE OTHER THAN SHALLOW RAPID BREATHS AND A PULSE OF 99 BEATS/MIN. ARTERIAL OXYGEN SATURATION WAS >95% ON 2 L/MIN OF OXYGEN BY NASAL CANNULA; THE BLOOD GAS ON ADMISSION SHOWED A PAO2 OF 73 MM HG, PACO2 OF 41 MM HG, AND A PH OF 7.42 ON ROOM AIR. HIS INITIAL D-DIMER WAS 2.6 UG/ML FIBRINOGEN EQUIVALENT UNITS (NORMAL IS 0.0-035 UG/ML, FIBRINOGEN UNITS). THE CHEST RADIOGRAPH SHOWED BIBASILAR PERIPHERAL HAZY OPACITIES. A DOPPLER STUDY OF THE LOWER EXTREMITIES WAS NEGATIVE FOR VENOUS THROMBOSIS. THE COMPUTED TOMOGRAPHY (CT) PULMONARY ANGIOGRAMS OF HIS CHEST DID NOT SHOW ANY EVIDENCE FOR PULMONARY EMBOLI OR EMPHYSEMA, BUT DID REVEAL EXTENSIVE PATCHY BILATERAL GROUND GLASS OPACITIES THAT WERE PREDOMINATELY IN THE PERIPHERY OF THE RIGHT MIDDLE LOBE, BUT ALSO PRESENT IN THE RIGHT AND LEFT LOWER LOBES AND THE LEFT LINGULA. PROMINENT SEPTAL LINES WERE ALSO VISIBLE IN THE LUNG WINDOWS OF THE CT. THE SYMPTOMS RESOLVED SPONTANEOUSLY WITHIN 48 HOURS, AND THE PATIENT WAS DISCHARGED HOME WITH ANALGESICS FOR KNEE PAIN; NO SUPPLEMENTARY OXYGEN WAS REQUIRED. UNK - PULMONARY FUNCTION TESTS (PFTS) PERFORMED 3 WEEKS AFTER THIS HOSPITALIZATION SHOWED NORMAL SPIROMETRY, AND NO FURTHER PULMONARY TESTING WAS PERFORMED, ACCORDING TO THE INSTITUTION'S THERAPIST-DIRECTED PFT ALGORITHM. WHILE CHEST CT CONTINUED TO SHOW AREAS OF GROUND GLASS OPACITY, THE PATIENT REFUSED THE RECOMMENDED BRONCHOSCOPY SINCE HE WAS ASYMPTOMATIC. UNK - DURING A FOLLOW-UP CLINIC VISIT 3 MONTHS LATER, THE PULMONARY CONSULTANT ORDERED A FULL SET OF PFTS. AGAIN, THE AIR FLOWS WERE NORMAL, AS WERE THE LUNG VOLUMES, BUT THE DLCO WAS ABNORMAL (19.1 ML/MIN/MM HG. 63% PREDICTED). SINCE THE GROUND GLASS OPACITIES CONTINUED TO PERSIST, THE PATIENT CONSENTED TO FIBEROPTIC BRONCHOSCOPY AND AN OPEN LUNG BIOPSY. THE BRONCHOALVEOLAR LAVAGE FLUID SHOWED MACROPHAGES WITH A FEW NEUTROPHILS AND EOSINOPHILS; BENIGN BRONCHIAL EPITHELIAL CELLS WERE ALSO PRESENT. A 2-DIMENSIONAL ECHOCARDIOGRAM SHOWED NORMAL LEFT VENTRICULAR FUNCTION, WITH NO IMPORTANT VALVULAR ABNORMALITIES. THE BIOPSY PERFORMED ON THE RIGHT MIDDLE LOBE, WHICH SHOWED RESPIRATORY BRONCHIOLITIS WITH AN AMORPHOUS SUBSTANCE PRESENT IN MANY MEDIUM AND SMALL PULMONARY ARTERIES. LYMPHATIC VESSELS WERE DILATED, AND NUMEROUS ALVEOLAR PIGMENTED MACROPHAGES WERE PRESENT. A DIAGNOSIS OF RESPIRATORY BRONCHIOLITIS AND EMPHYSEMA ASSOCIATED WITH MILD BRONCHIOLAR FIBROSIS AND FOCAL PERIBRONCHIAL METAPLASIA WAS CONFIRMED IN A REVIEW OF THE CASE BY THE ARMED FORCES INSTITUTE OF PATHOLOGY. A BONE MARROW EMBOLUS WAS ALSO NOTED. SUBSEQUENTLY. SPECIAL STAINS INDICATED THAT THE AMORPHOUS MATERIAL CONTAINED HA CO-LOCALIZED WITH FIBRIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUPARTZ SODIUM HYALURONATE MOZ SEIKAGAKU CORPORATION NA

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Hospitalization DAILY DOSE| INITIAL DATE| ROUTE OF ADMIN| FINAL DATE OF ADMIN| TRADE NAME (GENERIC NAME)