BEUDAMED
    FDA Adverse Event Death Summary report: N

    NC TREK NEO¿

    MDR report key: 20095165 · Received August 29, 2024

    Report

    Report Number
    2024168-2024-10229
    Event Type
    Death
    Date Received
    August 29, 2024
    Date of Event
    March 1, 2024
    Report Date
    September 20, 2024
    Manufacturer
    ABBOTT VASCULAR INC.
    Product Code
    LOX
    PMA / PMN Number
    K220634
    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 EFFECT OF DEATH IS LISTED IN THE CORONARY DILATATION CATHETERS (CDC), NC TREK NEO, INSTRUCTION FOR USE IFU, 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 EFFECT, 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.

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION IS STILL PENDING AT THIS TIME. RESULTS AND CONCLUSIONS WILL BE PROVIDED IN THE FINAL REPORT. B2 - DATE OF DEATH: ESTIMATED AS (B)(6) 2024. B3 - DATE OF EVENT: ESTIMATED AS 03/01/2024. D4 - PRIMARY UDI NUMBER: THE UDI IS NOT KNOWN AS THE PART AND LOT NUMBER WERE NOT PROVIDED. THE ADDITIONAL DEVICE REFERENCED IN B5 IS FILED UNDER A SEPARATE MEDWATCH REPORT NUMBER. THE ADDITIONAL PATIENT EFFECTS AND MALFUNCTIONS LISTED IN THE REPORT ARE CAPTURED UNDER SEPARATE MEDWATCH REPORTS. LITERATURE ATTACHMENT: ARTICLE TITLE "POST MARKET CLINICAL FOLLOW-UP EVALUATION REPORT NC TREK NEO CORONARY DILATATION CATHETER".

    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 NC TREK NEO CORONARY DILATATION CATHETERS (CDCS). KEY SAFETY OUTCOMES COLLECTED WERE PERFORATION, DISSECTION, EMBOLISM, ARRHYTHMIAS, MI, OCCLUSION, THROMBUS, AND DEATH. THE WEIGHTED AVERAGE OF THE SAFETY COMPOSITE RANGED FROM 0% TO (B)(4)%. DEVICE PERFORMANCE WAS DEFINED AS SUCCESSFUL DELIVERY, INFLATION, DEFLATION, AND WITHDRAWAL OF THE CDCS. THERE WERE ZERO INSTANCES OF BALLOON DEFLATION ISSUES FOR THIS DEVICE. THERE WAS OFF-LABEL USAGE AS A SMALL PERCENTAGE OF THIS DEVICE WAS NOT USED TO TREAT CORONARY VESSELS. 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
    1911498 NC TREK NEO¿ CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX ABBOTT VASCULAR INC. UNK NC TREK NEO

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death