BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DOWNSTREAM® SYSTEM

    MDR report key: 16078262 · Received December 30, 2022

    Report

    Report Number
    2030964-2022-00007
    Event Type
    Injury
    Date Received
    December 30, 2022
    Date of Event
    December 2, 2022
    Report Date
    June 18, 2025
    Manufacturer
    THEROX INC
    Product Code
    MWG
    PMA / PMN Number
    P170027
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZOLL HAS NOT YET RECEIVED THE DOWNSTREAM CONSOLE IN THE COMPLAINT FOR INVESTIGATION. A SUPPLEMENTAL REPORT WILL BE FILED IF AND WHEN THE PRODUCT IS RETURNED AND INVESTIGATION HAS BEEN COMPLETED. EVENT WAS SERIOUS AS THE PATIENT REQUIRED RE-STENTING. EVENT COULD BE POSSIBLY RELATED TO DEVICE AND PROCEDURE DUE TO RELEVANT TIMING AND LOCATION BASED ON REGULATORY DEFINITION: "THE RELATIONSHIP WITH THE USE OF THE INVESTIGATIONAL DEVICE OR PROCEDURE IS WEAK BUT CANNOT BE RULED OUT COMPLETELY. ALTERNATIVE CAUSES ARE ALSO POSSIBLE (E.G. AN UNDERLYING OR CONCURRENT ILLNESS/ CLINICAL CONDITION OR/AND AN EFFECT OF ANOTHER DEVICE, DRUG OR TREATMENT). CASES WHERE RELATEDNESS CANNOT BE ASSESSED OR NO INFORMATION HAS BEEN OBTAINED SHOULD ALSO BE CLASSIFIED AS POSSIBLE". THE PATIENT'S CONDITION COULD CONTRIBUTE TO DEVELOPMENT OF ACUTE ST (STENT THROMBOSIS) AS A KNOWN COMPLICATION. SUPERSATURATED OXYGEN (SSO2) THERAPY IS AN ADJUNCTIVE CARDIAC CATHETERIZATION LABORATORY-INITIATED PROCEDURE TARGETED AT THE LEFT MAIN CORONARY ARTERY (LMCA) OF AN ACUTE MYOCARDIAL INFARCTION (AMI) PATIENT AFTER SUCCESSFUL PERCUTANEOUS INTERVENTION (PCI) WITH STENTING HAS BEEN PERFORMED OF THE LEFT ANTERIOR DESCENDING CORONARY ARTERY. THE THEROX DOWNSTREAM SYSTEM IS INDICATED FOR THE PREPARATION AND DELIVERY OF SUPERSATURATED OXYGEN THERAPY (SSO2 THERAPY) TO TARGETED ISCHEMIC REGIONS PERFUSED BY THE PATIENT'S LEFT ANTERIOR DESCENDING CORONARY ARTERY IMMEDIATELY FOLLOWING REVASCULARIZATION BY MEANS OF PERCUTANEOUS CORONARY INTERVENTION (PCI) WITH STENTING THAT HAS BEEN COMPLETED WITHIN 6 HOURS AFTER THE ONSET OF ANTERIOR ACUTE MYOCARDIAL INFARCTION (AMI) SYMPTOMS CAUSED BY A LEFT ANTERIOR DESCENDING ARTERY INFARCT LESION. THE CUSTOMER PROBABLY WILL BENEFIT FROM ADDITIONAL FOLLOW UP TRAINING.

    Additional Manufacturer Narrative · 0

    THE CONSOLE IN THE COMPLAINT HAS NOT BEEN RETURNED FOR INVESTIGATION, HOWEVER, THE LOG FILES WERE REVIEWED. ACCORDING TO THE LOG FILES, ALL DEVICE OPERATION WAS AS DESIGNED AND THERE WERE NO DEVICE FAILURES. THERE IS NO OBSERVED RELATIONSHIP BETWEEN CIRCUIT PRESSURE AND CHEST PAIN; A THROMBUS ISSUE CANNOT BE DETERMINED USING THE LOG FILES.

    Description of Event or Problem · 0

    SSO2 THERAPY WAS INITIATED FOR THE 58-YEAR-OLD MALE PATIENT USING THE DOWNSTREAM CONSOLE (SN: (B)(4). THE PATIENT HAD BEEN EXPERIENCING CHEST PAIN FOR 2 WEEKS PRIOR TO SEEKING MEDICAL ATTENTION WHEN THE PAIN BECAME MORE SEVERE. APPROXIMATELY 25 MINUTES INTO THE SSO2 THERAPY, THE PATIENT STARTED TO COMPLAIN OF CHEST PAIN AND THEN SHORTNESS OF BREATH. A NON-REBREATHER MASK WAS PLACED, MEDICATION WAS GIVEN, AND A FLUOROSCOPY WAS DONE TO VERIFY THE CATHETER PLACEMENT. THE CATHETER WAS STILL ENGAGED, HOWEVER, THE PHYSICIAN WANTED TO TAKE A CONTRAST PHOTO. THE CUSTOMER DISCUSSED THE OPTION OF PAUSING OR STOPPING THERAPY. THE PHYSICIAN OPTED TO DO THE CONTRAST AND PUT THE SYSTEM INTO A PAUSED MODE. ONCE CONTRAST WAS INJECTED, A STENT THROMBOSIS WAS NOTED AT THE NEWLY PLACED STENT SITE. THE CUSTOMER REPORTED IT IS UNDETERMINED IF THE CLOT IS RELATED TO THE ZOLL DEVICE. THE PATIENT WAS GIVEN INTEGRILIN AND HEPARIN. HEPARIN WAS ALSO DELIVERED THROUGHOUT THE SSO2 TREATMENT. NO VESSEL INJURY DUE TO THE CATHETER WAS REPORTED. AT THIS TIME, THE 99 SECOND TIMER SHUTDOWN BEFORE THE COUNTDOWN WAS OVER, WITH ABOUT 30 SECONDS LEFT. AT THIS POINT, THE PHYSICIAN OPTED TO END AND NOT RESTART SSO2 THERAPY. THE PHYSICIAN FELT THE 38 MINUTES OF THERAPY WAS SUFFICIENT CONSIDERING THE PATIENT'S CHANGE IN STATUS. THE CLOT WAS REMOVED BY THE PHYSICIAN AND THE PATIENT WAS RE-STENTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2239582 DOWNSTREAM® SYSTEM SYSTEM, OXYGEN, AQUEOUS MWG THEROX INC DS-2

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Male Other