BEUDAMED
    FDA Adverse Event Death Summary report: N

    MINI TREK CORONARY DILATATION CATHETER

    MDR report key: 6080790 · Received November 4, 2016

    Report

    Report Number
    2024168-2016-07633
    Event Type
    Death
    Date Received
    November 4, 2016
    Date of Event
    October 13, 2016
    Report Date
    January 16, 2017
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LOX
    PMA / PMN Number
    K103110
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. CONCOMITANT MEDICAL PRODUCTS: GUIDE WIRE: FIELDER; STENT: 2.25 X 28 MM, 2.25 X 28 MM AND 2.25 X 12 MM XIENCE ALPINE STENTS; 3.0 X 12 MM ABSORB SCAFFOLD. THE CUSTOMER REPORTED THE DEVICE WAS DISCARDED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION. THE XIENCE ALPINE (2.25X12, (2) 2.25X28), ABSORB GT1, AND FIELDER XT 190 REFERENCED ARE BEING FILED UNDER SEPARATE MEDWATCH REPORT NUMBERS.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE LOT HISTORY RECORD AND COMPLAINT HISTORY COULD NOT BE CONDUCTED BECAUSE THE LOT NUMBER WAS NOT PROVIDED. BASED ON THE CASE INFORMATION, A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED. HOWEVER, DEATH AND PERFORATION ARE LISTED IN THE CORONARY DILATATION CATHETER MINI TREK RX 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2016 THE PATIENT PRESENTED WITH SEVERE CHEST PAIN IN WHICH A 3.0 X 12 MM ABSORB SCAFFOLD, A 2.25 X 28 MM, 2.25 X 28 MM AND 2.25 X 12 MM XIENCE ALPINE STENTS WERE IMPLANTED IN THE LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY. PRE-DILATATION AND POST DILATATION WERE PERFORMED SUCCESSFULLY. THE PATIENT WAS GIVEN PLAVIX AND ASPIRIN. HOWEVER, APPROXIMATELY 7 - 8 HOURS LATER, THE PATIENT EXPERIENCED SEVERE CHEST PAIN AND CODED. THE PATIENT WAS SENT BACK TO THE CATH LAB FOR PERCUTANEOUS TRANSLUMINAL INTERVENTION (PTI). ANGIOGRAPHY REVEALED ACUTE THROMBOSIS OF THE STENTS AND SCAFFOLD. A FIELDER GUIDE WIRE WAS ADVANCED FOLLOWED BY A 2.0 X 15 MM MINI TREK BALLOON CATHETER WHICH RESTORED A GOOD FLOW; HOWEVER, THE PATIENT CODED DUE TO A PERFORATION NOTED IN THE APEX. CHEST COMPRESSIONS WERE PERFORMED, BUT THE PATIENT DIED SUBSEQUENTLY. REPORTEDLY, CAUSE OF DEATH WAS TO NON-RESPONSE TO PLAVIX, SO IT WAS PROCEDURE RELATED. THERE WAS NO AUTOPSY PERFORMED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    731174 MINI TREK CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA-CT

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Death