BEUDAMED
    FDA Adverse Event Injury Summary report: N

    APEX¿ PUSH

    MDR report key: 2123050 · Received June 14, 2011

    Report

    Report Number
    2134265-2011-02203
    Event Type
    Injury
    Date Received
    June 14, 2011
    Date of Event
    January 19, 2011
    Report Date
    May 16, 2011
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    LOX
    PMA / PMN Number
    P860019
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). DEVICE EVALUATED BY MANUFACTURER: AS THE DEVICE HAS NOT BEEN RETURNED, THE COMPLAINT INVESTIGATION SITE (CIS) COULD NOT PERFORM A TECHNICAL ANALYSIS. THE BATCH NUMBER IS UNKNOWN AND THE MANUFACTURING RECORDS FOR THE COMPLAINT DEVICE COULD NOT BE REVIEWED. THE ROOT CAUSE IS ANTICIPATED PROCEDURAL COMPLICATIONS AS THIS EVENT IS A KNOWN PHYSIOLOGICAL EFFECT OF THE PROCEDURE AND IS NOTED WITHIN THE DFU. (B)(4).

    Additional Manufacturer Narrative · 1

    DESCRIBE EVENT UPDATED.(B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT TARGET LESION 1 LOCATED IN THE PROXIMAL RIGHT CORONARY ARTERY AND WAS TREATED WITH PRE-DILATATION AND IMPLANTING OVERLAPPING 4.0 X 38 MM, 3.5 X 28 MM , 2.5 X 8 MM, 2.75 X 8 MM, AND 4.0 X 12 MM PROMUS ELEMENT STENTS WITH 0% RESIDUAL STENOSIS. POST INDEX PROCEDURE, THE PATIENT HAD ELEVATED TROPONIN. AND A MYOCARDIAL INFARCTION WAS REPORTED. THE PATIENT DID NOT EXPERIENCE ISCHEMIC SYMPTOMS AND NO ACTION WAS TAKEN TO TREAT THIS EVENT.

    Description of Event or Problem · 1

    (B)(4) STUDY. IT WAS REPORTED THAT DURING A CORONARY ARTERY TREATMENT PROCEDURE A DISSECTION OCCURRED. LESION 1 WAS LOCATED IN THE PROXIMAL RIGHT CORONARY ARTERY (RCA). THE PHYSICIAN TREATED THE LESION WITH PRE-DILATATION AND PLACEMENT OF A 4.0 X 38 MM PROMUS ELEMENT STENT WITH 0% RESIDUAL STENOSIS. LESION 2 WAS LOCATED IN THE MID RCA. THE PHYSICIAN TREATED THE LESION WITH PRE-DILATATION AND PLACEMENT OF A 3.5 X 28 MM PROMUS ELEMENT STENT WITH 0% RESIDUAL STENOSIS. LESION 3 WAS LOCATED IN THE DISTAL RCA. THE PHYSICIAN TREATED THE LESION WITH PRE-DILATION AND PLACEMENT OF 2.5 X 8 MM AND 2.75 X 8 MM PROMUS ELEMENT STENTS WITH 0% RESIDUAL STENOSIS.. LESION 4 WAS LOCATED IN THE ACUTE MARGINAL (AC) BRANCH. THE PHYSICIAN TREATED THE LESION WITH PLACEMENT OF A 4.0 X 12 MM PROMUS ELEMENT STENT WITH 0% RESIDUAL STENOSIS. DURING THE INDEX PROCEDURE, IT WAS NOTED THAT THE RCA WAS TREATED WITH PRE-DILATATION USING A 1.5 X 12 MM APEX PUSH BALLOON AND A 2.0 X 20 MM NON BSC BALLOON. AFTER PRE-DILATATION WAS PERFORMED, A SPIRAL DISSECTION WAS NOTED FROM THE PROXIMAL RCA TO THE ACUTE MARGIN. THE DISSECTION WAS TREATED WITH PLACEMENT OF OVERLAPPING 3.5 X 28 MM AND 4.0 X 38 MM PROMUS ELEMENT STENTS. FOLLOWING PLACEMENT OF TWO PROMUS ELEMENT STENTS, A DISTAL DISSECTION WAS NOTED. THIS WAS TREATED WITH PLACEMENT OF OVERLAPPING 2.5 X 8 MM AND 2.75 X 8 MM PROMUS ELEMENT STENTS. IT WAS ALSO NOTED THAT A 4.0 X 12 MM PROMUS ELEMENT STENT WAS PLACED IN THE AC MARGINAL. FINAL ANGIOGRAPHY SHOWED EXCELLENT RESULTS.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE TARGET LESION WAS 100% STENOSED AND WAS 90 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 3.2 MM.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention CORDS FIRESTAR BALLOON