BEUDAMED
    FDA Adverse Event Death Summary report: N

    NC TREK NEO¿

    MDR report key: 22754749 · Received August 8, 2025

    Report

    Report Number
    2024168-2025-08287
    Event Type
    Death
    Date Received
    August 8, 2025
    Date of Event
    July 18, 2025
    Report Date
    September 12, 2025
    Manufacturer
    ABBOTT VASCULAR INC.
    Product Code
    LOX
    UDI-DI
    08717648232398
    PMA / PMN Number
    K220634
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED FOR ANALYSIS. PRODUCTION RECORD AND CORRECTIVE AND PREVENTATIVE ACTIONS (CAPA) REVIEWS WERE PERFORMED AND REVEALED NO INDICATION OF A PRODUCT QUALITY ISSUE. ADDITIONALLY, A REVIEW OF THE COMPLAINT HISTORY IDENTIFIED NO OTHER SIMILAR COMPLAINTS FROM THIS LOT. BASED ON THE INFORMATION PROVIDED AND THE MEDICAL REVIEW, IT IS POSSIBLE THAT THE INSTRUCTIONS FOR USE (IFU) VIOLATION OF OVERINFLATING THE BALLOON MAY HAVE CONTRIBUTED TO VESSEL STRESS DURING THE PROCEDURE; HOWEVER, A DEFINITIVE CAUSE FOR THE RELATIONSHIP OF OVER INFLATING THE BALLOON TO THE PATIENT EFFECTS OF PERFORATION OF VESSELS, CARDIAC TAMPONADE AND DEATH COULD NOT BE DETERMINED. ADDITIONALLY, THE REPORTED PATIENT EFFECTS OF SURGICAL INTERVENTION, UNEXPECTED MEDICAL INTERVENTION AND HOSPITALIZATION APPEAR TO BE RELATED TO CIRCUMSTANCES OF THE PROCEDURE. THE REPORTED PATIENT EFFECTS OF PERFORATION, CARDIAC TAMPONADE AND DEATH ARE LISTED IN THE CORONARY DILATATION CATHETERS (CDC), NC TREK NEO, INSTRUCTION FOR USE AS KNOWN PATIENT EFFECTS. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO THE DESIGN, MANUFACTURE, OR LABELING OF THE DEVICE.

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION IS STILL PENDING AT THIS TIME. RESULTS AND CONCLUSIONS WILL BE PROVIDED IN THE FINAL REPORT. H6: MEDICAL DEVICE PROBLEM CODE 2017: ABOVE RBP.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE DISTAL LEFT ANTERIOR DESCENDING (DLAD). ON (B)(6) 2025, AN UNSPECIFIED STENT WAS IMPLANTED. THEN 2.5X8MM NC TREK NEO BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE DISTAL END OF THE STENT WITHOUT ISSUE FOR POST DILATATION. THE BALLOON WAS INFLATED ABOVE THE RATED BURST PRESSURE OF 18 THREE TIMES TO 18, 23 AND 25 ATMOSPHERES (ATM). THE BDC WAS REMOVED WITH NO IMAGING PERFORMED. ANOTHER UNSPECIFIED BALLOON WAS ADVANCED FOR POST DILATION FOR THE PROXIMAL END OF THE STENT. THEN IMAGING WAS PERFORMED WHEN A PERFORATION WAS NOTED AT THE DISTAL END OF THE IMPLANTED STENT AND CARDIAC TAMPONADE WAS OBSERVED. THEREFORE, 2 COVERED UNSPECIFIED STENTS WERE PLACED TO TREAT THE PERFORATION, A STERNOTOMY WAS PERFORMED, AN IMPELLA DEVICE WAS PLACED AND PERICARDIOCENTESIS WAS PERFORMED, WHICH RESULTED IN ADDITIONAL HOSPITALIZATION AS THIS WAS INITIALLY AN OUT PATIENT PROCEDURE. ON (B)(6) 2025, THE PATIENT DIED. IN THE PHYSICIANS OPINION, THE AGGRESSIVE INFLATION OF THE NC TREK CAUSED BOTH THE PERFORATION AND TAMPONADE WHICH LED TO THE PATIENT DEATH. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203898 NC TREK NEO¿ CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX ABBOTT VASCULAR INC. 1400250-08 50421G1 08717648232398

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Female Death