BEUDAMED
    FDA Adverse Event Death Summary report: N

    NC QUANTUM APEX PTCA DILATATION CATHETER

    MDR report key: 2103042 · Received May 25, 2011

    Report

    Report Number
    2134265-2011-01918
    Event Type
    Death
    Date Received
    May 25, 2011
    Date of Event
    April 27, 2011
    Report Date
    April 27, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    LOX
    PMA / PMN Number
    P860019
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    SAME CASE AS MFR# 2134265-2011-01910. IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE SLOW FLOW OCCURRED AND POST PROCEDURE THE PATIENT EXPERIENCED A STROKE AND EXPIRED. ACCESS WAS OBTAINED VIA THE FEMORAL ARTERY. THE 90% STENOSED, 2.5X25MM DENOVO AND CONCENTRIC TARGET LESION WAS LOCATED IN THE 90 DEGREE ANGLED, SEVERELY TORTUOUS AND SEVERELY CALCIFIED CIRCUMFLEX ARTERY (CX). THE PATIENT PRESENTED DUE TO AN IRREGULAR STRESS TEST. THE LESION WAS PREDILATED WITH A 2.0X15MM NC QUANTUM APEX BALLOON AT 16ATMS FOR 30 SECONDS. A 2.5X12MM TAXUS LIBERTE STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TO THE LESION; HOWEVER, DEVICE WAS UNABLE TO CROSS THE LESION AND THE SDS WAS REMOVED FROM THE PATIENT. WHEN THE SDS WAS REMOVED IT WAS NOTED THAT THE STENT WAS NO LONGER MOUNTED ON THE BALLOON. THE PHYSICIAN ADVANCED A 2.0X8MM NC QUANTUM APEX BALLOON CATHETER TO THE 70% STENOSED LEFT MAIN (LM) WHERE HE BELIEVED THE DISLODGED STENT WAS LOCATED. THE BALLOON WAS INFLATED AND THE STENT WAS CRUSHED AGAINST THE VESSEL WALL. AN ANGIOGRAM WAS PERFORMED AND SLOW FLOW WAS NOTED IN THE CX, WHICH THE PHYSICIAN BELIEVED WAS DUE TO THE CRUSHING OF THE DISLODGED STENT IN THE LM. THE PROCEDURE WAS STOPPED AT THIS POINT. IT WAS NOTED THAT THE PATIENT LATER BECAME AGITATED AND WAS INTUBATED. THE PATIENT WAS REPORTED TO HAVE LOW PRESSURE FOR 12 HOURS AND 48 HOURS AFTER THE PROCEDURE THE PATIENT EXPERIENCED A STROKE AND EXPIRED. THE DOCUMENTED CAUSE OF DEATH IS STROKE AND IT WAS NOTED THAT THE PATIENT HAD OTHER HEALTH ISSUES AND THE PHYSICIAN DOES NOT BELIEVE THAT THE PATIENT'S DEATH WAS DUE TO THE IMPLANTED STENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NC QUANTUM APEX PTCA DILATATION CATHETER CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC - MAPLE GROVE H7493912408200

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Death 2.0X15MM NC QUANTUM APEX BALLOON CATHETER| 2.5X12MM TAXUS LIBERTE STENT