BEUDAMED
    FDA Adverse Event Death Summary report: N

    MINI TREK¿

    MDR report key: 20087522 · Received August 28, 2024

    Report

    Report Number
    2024168-2024-10151
    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
    K123279
    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 EVALUATION. THE CORRECTIVE AND PREVENTIVE ACTIONS (CAPA) REVIEW WAS PERFORMED AND REVEALED NO INDICATION OF A PRODUCT QUALITY ISSUE. THE PRODUCTION RECORD FOR THIS PRODUCT COULD NOT BE REVIEWED AND A COMPLAINT REVIEW COULD NOT BE PERFORMED BECAUSE THE PRODUCT WAS NOT RETURNED FOR EVALUATION AND THE PART AND LOT NUMBERS WERE NOT REPORTED. THE REPORTED PATIENT EFFECTS OF DEATH IS LISTED IN THE CORONARY DILATATION CATHETERS (CDC), MINI TREK II OTW, GLOBAL, INSTRUCTIONS FOR USE AS A KNOWN PATIENT EFFECT. BASED ON THE INFORMATION REPORTED THROUGH THE PMCF (POST-MARKET CLINICAL FOLLOW-UP) REPORT, A CONCLUSIVE CAUSE FOR THE REPORTED COMPLAINTS COULD NOT BE DETERMINED. ADDITIONALLY, A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING. THE ADDITIONAL PATIENT EFFECTS AND MALFUNCTIONS LISTED IN THE REPORTED ARE CAPTURED UNDER SEPARATE MEDWATCH REPORTS. LITERATURE ATTACHMENT: ARTICLE TITLE ¿POST MARKET CLINICAL FOLLOW-UP EVALUATION REPORT CORONARY DILATATION CATHETERS.¿ THE NC TRAVELER RX DEVICE IS CURRENTLY NOT COMMERCIALLY AVAILABLE IN THE US; HOWEVER, IT IS SIMILAR TO A DEVICE SOLD IN THE US. B2: DATE OF DEATH ESTIMATED AS (B)(6) 2024. B3: DATE OF EVENT ESTIMATED AS 3/1/2024. D4: 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    158736 MINI TREK¿ CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX ABBOTT VASCULAR INC. UNK OTW MINI TREK II

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death