BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DOWNSTREAM® SYSTEM

    MDR report key: 16660764 · Received April 1, 2023

    Report

    Report Number
    2030964-2023-00003
    Event Type
    Injury
    Date Received
    April 1, 2023
    Date of Event
    November 13, 2021
    Report Date
    July 25, 2023
    Manufacturer
    THEROX INC
    Product Code
    MWG
    PMA / PMN Number
    P170027
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: B5, DESCRIBE EVENT OR PROBLEM. FROM: "AFTER PCR PRIOR TO INITIATING SS02, AN ACT WAS OBTAINED TO CONFIRM THERAPEUTIC LEVELS OF ANTICOAGULATION." TO: "AFTER PCI PRIOR TO INITIATING SS02, AN ACT WAS OBTAINED TO CONFIRM THERAPEUTIC LEVELS OF ANTICOAGULATION.". CORRECTION TO THE MFR REPORT NUMBER FROM: "3010617000-2023-00003" TO: "2030964-2023-00003".

    Additional Manufacturer Narrative · 0

    ZOLL HAS NOT RECEIVED THE DOWNSTREAM CONSOLE IN THE COMPLAINT FOR INVESTIGATION. A SUPPLEMENTAL REPORT WILL BE FILED IF AND WHEN THE PRODUCT IS RETURNED AND THE INVESTIGATION HAS BEEN COMPLETED. 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. EVENT WAS SERIOUS AS EVENT REQUIRED ADDITIONAL INTERVENTION. TIMI POST INITIAL PCI WAS 2-3. ACCORDING TO AVAILABLE INFORMATION, THE 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". THE CUSTOMER PROBABLY WILL BENEFIT FROM ADDITIONAL FOLLOW-UP TRAINING, WHICH WAS REQUESTED. EVENT IS ANTICIPATED (ST CAN OCCUR AFTER PCI) AND IS "POSSIBLY" RELATED TO THE DEVICE AND PROCEDURE.

    Description of Event or Problem · 0

    THE PATIENT WAS INITIALLY ADMITTED WITH STEMI AND THE TARGET VESSEL WAS LAD. THE PATIENT RECEIVED HEPARIN DURING PCI. AFTER A PCI AND BEFORE SSO2 THERAPY, TIMI FLOW GRADE 2 OR 3. AFTER PCI PRIOR TO INITIATING SS02, AN ACT WAS OBTAINED TO CONFIRM THERAPEUTIC LEVELS OF ANTICOAGULATION. ANOTHER ACT WAS TAKEN AFTER 30 MINUTES OF SS02 THERAPY AND ADDITIONAL ANTICOAGULATION WAS ADMINISTERED IN AN UNKNOWN DOSAGE. THEROX DEVICE WAS USED FOR 60 MINUTES. POST-ANGIOPLASTY ANGIOGRAPHY OF THE LAD REVEALED A STENT IN THE PROXIMAL PORTION, WHILE REPEAT ANGIOGRAPHY AFTER SS02 TREATMENT SHOWED A PATENT STENT WITH MULTIPLE FILLING DEFECTS IN THE PROXIMAL AND MIDSEGMENTS OF THE LAD, INDICATING INTRACORONARY THROMBUS. THE PATIENT DIDN'T EXPERIENCE ANY CLINICAL SYMPTOMS SUGGESTED OF AN IN-STENT THROMBUS. IT WAS A FINDING DURING CORONARY ANGIOGRAPHY. POST-EXPORT THROMBECTOMY AND BALLOON DILATION OF THE PREVIOUSLY DEPLOYED STENT, THE SITE OF STENT DEPLOYMENT SHOWED NO RESIDUAL STENOSIS, THROMBUS, OR DISSECTION, AND THERE WAS TIMI GRADE 3 DISTAL FLOW. THE PATIENT WAS GIVEN ASPIRIN AND BRILINTA PRIOR TO THE INTERVENTIONAL PROCEDURE AND CONTINUED ON INTRAVENOUS INTEGRILIN POST-PROCEDURE DUE TO A THROMBUS IN THE PROXIMAL LAD STENT AREA, WHICH IMPROVED SIGNIFICANTLY AFTER MANUAL THROMBECTOMY AND REPEAT STENT DILATION. IN THE OPINION OF THE CUSTOMER, STENT THROMBOSIS WAS POTENTIALLY RELATED TO SSO2 THERAPY.

    Description of Event or Problem · 0

    THE PATIENT WAS INITIALLY ADMITTED WITH STEMI AND THE TARGET VESSEL WAS LAD. THE PATIENT RECEIVED HEPARIN DURING PCI. AFTER A PCI AND BEFORE SSO2 THERAPY, TIMI FLOW GRADE 2 OR 3. AFTER PCR PRIOR TO INITIATING SS02, AN ACT WAS OBTAINED TO CONFIRM THERAPEUTIC LEVELS OF ANTICOAGULATION. ANOTHER ACT WAS TAKEN AFTER 30 MINUTES OF SS02 THERAPY AND ADDITIONAL ANTICOAGULATION WAS ADMINISTERED IN AN UNKNOWN DOSAGE. THEROX DEVICE WAS USED FOR 60 MINUTES. POST-ANGIOPLASTY ANGIOGRAPHY OF THE LAD REVEALED A STENT IN THE PROXIMAL PORTION, WHILE REPEAT ANGIOGRAPHY AFTER SS02 TREATMENT SHOWED A PATENT STENT WITH MULTIPLE FILLING DEFECTS IN THE PROXIMAL AND MIDSEGMENTS OF THE LAD, INDICATING INTRACORONARY THROMBUS. THE PATIENT DIDN'T EXPERIENCE ANY CLINICAL SYMPTOMS SUGGESTED OF AN IN-STENT THROMBUS. IT WAS A FINDING DURING CORONARY ANGIOGRAPHY. POST-EXPORT THROMBECTOMY AND BALLOON DILATION OF THE PREVIOUSLY DEPLOYED STENT, THE SITE OF STENT DEPLOYMENT SHOWED NO RESIDUAL STENOSIS, THROMBUS, OR DISSECTION, AND THERE WAS TIMI GRADE 3 DISTAL FLOW. THE PATIENT WAS GIVEN ASPIRIN AND BRILINTA PRIOR TO THE INTERVENTIONAL PROCEDURE AND CONTINUED ON INTRAVENOUS INTEGRILIN POST-PROCEDURE DUE TO A THROMBUS IN THE PROXIMAL LAD STENT AREA, WHICH IMPROVED SIGNIFICANTLY AFTER MANUAL THROMBECTOMY AND REPEAT STENT DILATION. ACCORDING TO THE CUSTOMER, THERE WERE NO REPORTED PATIENT DEATH OR DEVICE-RELATED INJURY, AND NO CONSEQUENCES OR IMPACT TO THE PATIENT. IN THE OPINION OF THE CUSTOMER, STENT THROMBOSIS WAS POTENTIALLY RELATED TO SSO2 THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    380336 DOWNSTREAM® SYSTEM SYSTEM, OXYGEN, AQUEOUS MWG THEROX INC DS-2

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other