BEUDAMED
    FDA Adverse Event Death Summary report: N

    NC TREK

    MDR report key: 20087689 · Received August 28, 2024

    Report

    Report Number
    2024168-2024-10165
    Event Type
    Death
    Date Received
    August 28, 2024
    Date of Event
    March 1, 2024
    Report Date
    August 28, 2024
    Manufacturer
    ABBOTT VASCULAR INC.
    Product Code
    LOX
    PMA / PMN Number
    K113464
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED FOR ANALYSIS. A REVIEW OF THE CORRECTIVE AND PREVENTIVE ACTIONS (CAPA) DATABASE WAS PERFORMED AND REVEALED NO INDICATION OF A PRODUCT QUALITY ISSUE. A REVIEW OF PRODUCTION RECORDS AND THE COMPLAINT HANDLING DATABASE WAS NOT PERFORMED BECAUSE THE PART/LOT NUMBERS WERE NOT REPORTED. THE REPORTED PATIENT EFFECTS OF DEATH IS LISTED IN THE NC TREK OTW INSTRUCTION FOR USE AS A KNOWN PATIENT EFFECT OF CORONARY PROCEDURES. A CONCLUSIVE CAUSE FOR THE REPORTED DEATH CANNOT BE DETERMINED. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN, OR LABELING THE ADDITIONAL PATIENT EFFECTS, DEVICE MALFUNCTIONS AND DEVICES REPORTED IN THE PMCF ARE CAPTURED UNDER SEPARATE MEDWATCH REPORTS. LITERATURE ATTACHMENT: ARTICLE TITLE "POST MARKET CLINICAL FOLLOW-UP EVALUATION REPORT CORONARY DILATATION CATHETERS" B2 - DATE OF DEATH : ESTIMATED AS (B)(6) 2024. B3 - DATE OF EVENT: ESTIMATED AS (B)(6) 2024. D4 - PRIMARY UDI NUMBER: THE UDI IS NOT KNOWN AS THE PART AND LOT NUMBER WERE NOT PROVIDED.

    Description of Event or Problem · 0

    THIS IS FILED TO REPORT PATIENT DEATH. IT WAS REPORTED THROUGH THE PMCF (POST-MARKET CLINICAL FOLLOW-UP) REPORT, THAT ABBOTT PROACTIVELY COLLECTED AND EVALUATED DATA FROM SEVERAL SOURCES, SUCH AS IN-HOSPITAL OUTCOMES AND PHYSICIAN SURVEYS, TO CONFIRM THE SAFETY AND PERFORMANCE OF ABBOTT'S CORONARY DILATATION CATHETERS (CDCS). KEY SAFETY OUTCOMES COLLECTED WERE OCCLUSION, ACUTE MYOCARDIAL INFARCTION (AMI), EMBOLISM, VESSEL DISSECTION, VESSEL PERFORATION, ARRHYTHMIAS, AND DEATH. DEVICE PERFORMANCE WAS DEFINED AS SUCCESSFUL DELIVERY, INFLATION, AND DEFLATION OF THE CDCS. DETAILS ARE LISTED IN THE ATTACHED REPORT, TITLED POST-MARKET CLINICAL FOLLOW-UP EVALUATION REPORT CORONARY DILATATION CATHETERS. PLEASE SEE THE ATTACHED POST MARKET CLINICAL FOLLOW UP EVALUATION REPORT FOR SPECIFIC INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    191656 NC TREK CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX ABBOTT VASCULAR INC. UNK NC TREK OTW

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death