BEUDAMED
    FDA Adverse Event Death Summary report: N

    NC TREK NEO¿

    MDR report key: 24210852 · Received January 29, 2026

    Report

    Report Number
    2024168-2026-00404
    Event Type
    Death
    Date Received
    January 29, 2026
    Date of Event
    January 6, 2026
    Report Date
    March 27, 2026
    Manufacturer
    ABBOTT VASCULAR INC.
    Product Code
    LOX
    UDI-DI
    08717648232534
    PMA / PMN Number
    K220634
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION IS STILL PENDING AT THIS TIME. RESULTS AND CONCLUSIONS WILL BE PROVIDED IN THE FINAL REPORT.

    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 QUERY OF THE COMPLAINT HANDLING DATABASE FOR THE REPORTED LOT REVEALED THERE IS NO INDICATION OF A LOT SPECIFIC ISSUE. A MEDICAL REVIEW WAS RECEIVED AND REVIEWED BY AN ABBOTT VASCULAR CLINICAL SPECIALIST. THE REVIEWER CONCLUDED THAT THIS WAS A CASE TO TREAT AN 80-YEAR-OLD FEMALE WITH PRIOR MEDICAL HISTORY OF CORONARY ARTERIAL DISEASE (CAD). POST ATHERECTOMY USING A NON-ABBOTT DEVICE REVEALED A PERFORATION. THE PHYSICIAN TREATED THE PERFORATION WITH BALLOON TAMPONADE USING THE 3.0 X 20MM NC TREK NEO BALLOON DILATATION CATHETER. THE NC TREK NEO WAS ABLE TO SUCCESSFULLY TREAT THE PERFORATION. THE PHYSICIAN HAD TROUBLE DEFLATING THE BALLOON AND TRIED SEVERAL TECHNIQUES TO ACHIEVE DEFLATION. THE INFLATED BALLOON NECESSITATED EMERGENCY SURGERY; HOWEVER, THE PATIENT EXPIRED DURING TRANSPORTATION. BASED ON THE INFORMATION RECEIVED, THE INVESTIGATION DETERMINED THAT THE REPORTED ISSUES APPEARS TO BE RELATED TO OPERATIONAL CONTEXT IN THIS CASE, THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE ATTENDING PHYSICIAN STATED THAT THE REPORTED FAILURE TO DEFLATE COULD BE RELATED TO A POSSIBLE KINKED SHAFT AND INTERACTION WITH THE PATIENT¿S ANATOMY. IT IS POSSIBLE THAT HANDLING AND/OR MANIPULATION OF THE DEVICE AFTER INSERTION RESULTED IN A SHAFT KINK. THE KINKED SHAFT AND/OR HEAVILY CALCIFIED ANATOMY LIKELY CAUSED A NARROWED/RESTRICTED INFLATION LUMEN RESULTING IN THE REPORTED FAILURE TO DEFLATE. MULTIPLE ATTEMPTS WERE MADE TO DEFLATE THE DEVICE. THESE ATTEMPTS WERE UNSUCCESSFUL, RESULTING IN THE FOREIGN BODY IN PATIENT. THE CAUSE OF DEATH CANNOT BE ATTRIBUTED TO THE USE OF THE 3.0 X 20MM NC TREK NEO BALLOON DILATATION CATHETER (BDC). HOWEVER, IT IS REASONABLE TO STATE THAT THE NC TREK NEO WAS AN INDIRECT CONTRIBUTOR TO ADVERSE EVENTS BASED ON OPERATIONAL CONTEXT OF THE PROCEDURE. THE REPORTED PATIENT EFFECT OF DEATH IS LISTED IN THE CORONARY DILATATION CATHETERS (CDC), NC TREK NEO, INSTRUCTION FOR USE AS A KNOWN PATIENT EFFECT. BASED ON THE RESULTS OF THE COMPLAINT INVESTIGATION, THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO THE DESIGN, MANUFACTURE, OR LABELING OF THE DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A PROCEDURE TO TREAT A HEAVILY CALCIFIED RIGHT CORONARY ARTERY, A PERFORATION OCCURRED. THE 3.0 X 20MM NC TREK NEO BALLOON DILATATION CATHETER (BDC) WAS USED TO TREAT THE PERFORATION SUCCESSFULLY; HOWEVER, THE BALLOON COMPLETELY FAILED TO DEFLATE. THE BACK STIFF END OF AN UNSPECIFIED GUIDE WIRE WAS USED IN AN ATTEMPT TO POP THE BALLOON BUT WAS UNSUCCESSFUL. AN ATTEMPT TO SNARE THE BALLOON WAS MADE, BUT ALSO UNSUCCESSFUL. ANOTHER ATTEMPT TO POP THE BALLOON WAS MADE BY CUTTING THE BACKSIDE OF THE BDC SHAFT; HOWEVER, THIS WAS ALSO UNSUCCESSFUL. THE PATIENT WAS TO BE TRANSFERRED TO THE OPERATING ROOM; HOWEVER, DIED DURING TRANSPORT. IN THE PHYSICIAN OPINION, THE FAILURE TO DEFLATE THE BALLOON WAS DUE TO INTERACTION OF THE POSSIBLY KINKED SHAFT AND CALCIUM AND CONTRIBUTED TO THE DEATH. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    242270 NC TREK NEO¿ CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX ABBOTT VASCULAR INC. 1400300-20 51017G1 08717648232534

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Female Required Intervention| D