BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DOWNSTREAM® SYSTEM

    MDR report key: 17674647 · Received September 1, 2023

    Report

    Report Number
    2030964-2023-00004
    Event Type
    Injury
    Date Received
    September 1, 2023
    Date of Event
    August 11, 2023
    Report Date
    September 1, 2023
    Manufacturer
    THEROX INC
    Product Code
    MWG
    PMA / PMN Number
    K072234
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DOWNSTREAM CONSOLE IN THE COMPLAINT WILL NOT BE RETURNED FOR INVESTIGATION BECAUSE NO MALFUNCTION OCCURRED. THE DOWNSTREAM SYSTEM'S EVENT LOG DATA WAS REVIEWED BY ZOLL AND SHOWED THE SSO2 PROCEDURE STARTED NORMALLY AND RAN CONTINUOUSLY FOR OVER 35 MINUTES BEFORE THE USER SHUT THE SYSTEM DOWN. THE TREATMENT PARAMETERS INCLUDING BLOOD FLOW WERE STEADY THROUGHOUT THE PROCEDURE; THERE WAS NO INDICATION OF AN OPERATING ISSUE ON THE LOG FILE DURING THE PROCEDURE. THE PROCEDURE WAS ENDED BY THE USER JUST BEFORE 36 MINUTES OF TREATMENT WERE COMPLETED. 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. EVENT WAS SERIOUS AS EVENT REQUIRED ADDITIONAL INTERVENTION. ACCORDING TO AVAILABLE INFORMATION, EVENT OF ST ASSESSED AS POSSIBLE RELATED TO THEROX DEVICE BASED ON MEDDEV DEFINITION: "POSSIBLE: 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 WERE RELATEDNESS CANNOT BE ASSESSED OR NO INFORMATION HAS BEEN OBTAINED SHOULD ALSO BE CLASSIFIED AS POSSIBLE". EVENT IS ANTICIPATED (ST CAN OCCUR AFTER PCI) AND IS "POSSIBLY" RELATED TO THE DEVICE AND PROCEDURE.

    Description of Event or Problem · 0

    A PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT (ED) WITH SUDDEN-ONSET CEREBRAL PALSY (CP) WHILE PLAYING BADMINTON. IN THE EMERGENCY DEPARTMENT, AN ELECTROCARDIOGRAM (ECG) WAS PERFORMED, AND IT WAS DETERMINED THAT THE PATIENT WAS EXPERIENCING AN ANTERIOR ST-SEGMENT ELEVATION MYOCARDIAL INFARCTION (STEMI). THE PATIENT WAS THEN MOVED TO THE CARDIAC CATHETERIZATION LAB (CATH LAB) FOR INTERVENTION. THE PHYSICIAN PLACED 1 STENT ON THE LEFT ANTERIOR DESCENDING ARTERY (LAD) AND INITIATED THE SSO2 THERAPY USING THEROX DOWNSTREAM CONSOLE (SN (B)(6)). TWENTY-SIX MINUTES INTO THE SSO2 THERAPY, THE PATIENT EXPERIENCED MILD CHEST PAIN (2-3 OUT OF 10 ON THE PAIN SCALE). THE CHEST PAIN ESCALATED TO MORE SEVERE CHEST PAIN (7 OUT OF 10 ON THE PAIN SCALE) OVER 9 MINUTES. THERE WAS SLIGHT ST ELEVATION ON THE MONITOR INDICATIVE OF CORONARY OCCLUSION. THE PHYSICIAN BECAME CONCERNED ABOUT IN-STENT RESTENOSIS AND DECIDED TO DISCONTINUE THE SSO2 THERAPY AFTER A TOTAL DURATION OF 35 MINUTES AND OPTED TO EXAMINE THE CORONARY ARTERIES. IT WAS CONFIRMED THAT THE PATIENT HAD EXPERIENCED RE-OCCLUSION OF THE LAD STENT. THE PATIENT HAD DEVELOPED STENT THROMBOSIS AND CORONARY STENT OCCLUSION. THE PHYSICIAN THEN PERFORMED AN ANGIOPLASTY (BALLOONING) TO REOPEN THE BLOCKED ARTERY, AND STRONGER ANTICOAGULANT MEDICATIONS WERE INITIATED TO PREVENT FURTHER CLOT FORMATION. BEFORE INITIATING THE SSO2 THERAPY, ZOLL CLINICAL EDUCATOR HAD STARTED MONITORING THE PATIENT'S CLOTTING PARAMETERS. THE ACTIVATED CLOTTING TIME (ACT) WAS ASSESSED AT VARIOUS POINTS. AT THE START OF THE TREATMENT, IT WAS 274 SECONDS WITH INGESTION OF BRILINTA (AN ORAL ANTI-PLATELET). THE ACT WAS RECHECKED AT 26TH MINUTES INTO SSO2 THERAPY AND WAS BACK AT 211 SECONDS. THE PATIENT WAS ADMINISTERED 3000 UNITS/ML OF ADDITIONAL HEPARIN TO MANAGE CLOTTING. A SUBSEQUENT RECHECK OF ACT WAS 260 SECONDS, WHERE ANOTHER 3000 UNITS/ML OF HEPARIN WAS GIVEN. HOWEVER, DUE TO THE PATIENT'S CLOT BURDEN, THE PHYSICIAN DECIDED AGAINST RESTARTING SSO2 THERAPY TO COMPLETE THE FULL 60 MINUTES OF THERAPY. THE CUSTOMER DID NOT REPORT ANY DEVICE MALFUNCTION ON THE CONSOLE. THE PATIENT WAS DOING WELL WITH BALLOONING OF THE LAD ARTERY AND ADMINISTRATION OF ANTICOAGULATION AND ANTI-PLATELET MEDICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1455128 DOWNSTREAM® SYSTEM SYSTEM, OXYGEN, AQUEOUS MWG THEROX INC DS-2

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other