BEUDAMED
    FDA Adverse Event Death Summary report: N

    APEX PUSH MONORAIL

    MDR report key: 1813337 · Received August 24, 2010

    Report

    Report Number
    2134265-2010-03620
    Event Type
    Death
    Date Received
    August 24, 2010
    Date of Event
    July 27, 2010
    Report Date
    July 28, 2010
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    LOX
    PMA / PMN Number
    P860019
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER - THE COMPLAINANT 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 REPORT# 2134265-2010-03619. IT WAS REPORTED THAT POST A STENTING TREATMENT PROCEDURE, A PATIENT DEATH OCCURRED. THE PATIENT PRESENTED TO THE EMERGENCY ROOM WITH VENTRICULAR TACHYCARDIA AND WAS CARDIOVERTED, BUT REMAINED HYPOTENSIVE AND WAS NOTED TO BE CRITICALLY ILL. IN THE CATH LAB, SEVERE THREE VESSEL DISEASE WAS NOTED. THE PATIENT DECLINED SURGERY AND THE PHYSICIAN ELECTED TO STENT THE LEFT CIRCUMFLEX ARTERY (LCX), THE LEFT ANTERIOR DESCENDING ARTERY (LAD) AND THE RIGHT CORONARY ARTERY (RCA). FIRST, THE LCX WAS SUCCESSFULLY TREATED. THEN, THE PHYSICIAN TREATED THE LAD. THE 90% STENOSED LESION WAS LOCATED IN A SEVERELY CALCIFIED AND SEVERELY TORTUOUS LAD. THE LESION WAS PREDILATED WITH BOTH 1.5X12MM APEX PUSH BALLOON AND AN UNKNOWN 2.0MM BALLOON. THE PHYSICIAN ATTEMPTED TO ADVANCE A NON BSC STENT TO THE LESION, BUT IT COULD NOT CROSS. A 2.5X15MM NC QUANTUM APEX WAS ADVANCED TO THE LESION AND RUPTURED AT 11 ATMS ON THE FIRST INFLATION. A 2.5X10MM NON BSC BALLOON WAS ADVANCED TO THE MID LESION AND INFLATED TO 20 ATMS. A 2.5X18MM NON BSC STENT WAS PLACED IN THE LESION, FOLLOWED BY PLACEMENT OF A 2.5X15MM NON BSC STENT. IMMEDIATELY AFTER PLACEMENT OF THE 2.5X15MM STENT, A DISSECTION OF THE MID LAD WAS NOTED THAT PROPAGATED RETROGRADE INTO THE PROXIMAL LAD AND INTO THE LEFT MAIN ARTERY COMPROMISING THE ENTIRE LEFT SYSTEM. THE DISSECTION WAS TREATED WITH TWO ADDITIONAL STENTS WHICH RESTORED FLOW TO THE LEFT SYSTEM. THE RCA WAS THEN SUCCESSFULLY STENTED. THE PROCEDURE WAS COMPLETED BY PLACEMENT OF AN INTRA-AORTIC BALLOON PUMP. POST PROCEDURE, THE PATIENT WAS PLACED ON MULTIPLE VASOPRESSORS BUT REMAINED HYPOTENSIVE. APPROXIMATELY 6-8 HOURS POST PROCEDURE, THE PATIENT EXPIRED. THE PHYSICIAN NOTED THAT "ALTHOUGH THE PATIENT WAS CRITICALLY ILL AND HIS SURVIVAL WAS IN DOUBT THROUGHOUT THE COURSE OF THE CASE, THE LOSS OF THE LAD AND LEFT MAIN WERE THE KEY FACTORS THAT TIPPED THE SCALE AWAY FROM SURVIVAL FOR THIS PATIENT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 APEX PUSH MONORAIL CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC - MAPLE GROVE H7493896112150

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Death XB3.5 SHAPE GUIDE CATHETER| 2.5X15MM NC QUANTUM APEX BALLOON| 2.5X10MM DURASTAR BALLOON| PROWATER GUIDE WIRE| 2.5X18MM AND 2.5X15MM XIENCE STENT