BEUDAMED
    FDA Adverse Event Injury Summary report: N

    APEX MONORAIL

    MDR report key: 2111251 · Received June 2, 2011

    Report

    Report Number
    2134265-2011-02124
    Event Type
    Injury
    Date Received
    June 2, 2011
    Date of Event
    May 4, 2011
    Report Date
    May 4, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    LOX
    PMA / PMN Number
    P860019
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: THE DEVICE WAS NOT RETURNED FOR ANALYSIS, THEREFORE, PRODUCT ANALYSIS COULD NOT BE PERFORMED. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. 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).

    Description of Event or Problem · 1

    SAME CASE AS 2134265-2011-02186, 2134265-2011-02330, 2134265-2011-02331, 2134265-2011-02300 & 2134265-2011-02063. IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTIONAL PROCEDURE, A SPIRAL DISSECTION OCCURRED. THE MODERATELY TORTUOUS AND MODERATE TO SEVERELY CALCIFIED LESION WAS LOCATED IN THE MID TO PROXIMAL LEFT ANTERIOR DESCENDING (LAD). INITIALLY, A ROTATIONAL ATHERECTOMY TREATMENT PROCEDURE WAS PERFORMED WITH A 1.5MM ROTALINK PLUS UNIT. ONE ABLATION PASS WAS COMPLETED WITH THIS DEVICE. A 1.75MM ROTABLATOR BURR CATHETER WAS THEN EXCHANGED WITH THE BURR FROM THE 1.5MM ROTALINK PLUS AND PLATFORM TESTING WAS COMPLETED AT 165,000 RPMS. THE UNIT WAS THEN ADVANCED TO THE LESION AND APPROXIMATELY 2-3 ABLATION PASSES WERE MADE AND THEN IT WAS NOTED THAT THE SYSTEM SEEMED TO "SLIGHTLY JUMP FORWARD" AND THERE WAS NO CONTROL OF THE BURR WHEN MOVING THE ADVANCER KNOB BACK AND FORTH. THE SYSTEM WAS ABLE TO BE REMOVED BY PULLING IT ALL OUT OF THE BODY. THE ROTAWIRE WAS THEN REMOVED AND REPLACED WITH A 185CM KINETIX STRAIGHT GUIDE WIRE. A 3.0 X 12MM APEX BALLOON WAS USED TO PRE-DILATE THE LESION. AFTER INFLATING THE APEX BALLOON CATHETER, A SLIGHT SPIRAL DISSECTION WAS IDENTIFIED. IT WAS UNABLE TO BE DETERMINED THE CAUSE OF THE DISSECTION. THE APEX BALLOON WAS REMOVED AND A 2.75MM TAXUS LIBERTE STENT WAS USED TO COVER THE AREA DISTAL TO THE LESION. A SECOND 2.75 X 38MM TAXUS LIBERTE STENT WAS USED TO TREAT THE MID TO DISTAL AREA OF THE DISSECTION. THERE WAS A BIT OF A STRUGGLE TO GET THE STENT TO THE LESION. DURING INFLATION UP TO 14 ATMS, THE STENT SEEMED TO GET FULL EXPANSION. AFTER WAITING 8-9 SECONDS AFTER THE BALLOON WAS DEFLATED, THERE WAS BALLOON WITHDRAWAL RESISTANCE. THE BALLOON WAS REINFLATED FOR 3 SECONDS WHILE THE GUIDE CATHETER WAS DEEP SEATED INTO THE PROXIMAL LAD; HOWEVER, THERE WAS STILL WITHDRAWAL RESISTANCE AFTER THE BALLOON WAS DEFLATED. THE BALLOON WAS AGAIN INFLATED TO 3 ATMS AND DEFLATED AGAIN TO NEUTRAL FOR ABOUT 10 SECONDS. AFTER 3 - 4 SECONDS, THE SYSTEM DID RELEASE WITH SLIGHT RESISTANCE AND SOME DEEP SEATING OF THE GUIDE CATHETER WAS ALSO EXPERIENCED. AFTER THIS, SOME "DISRUPTION" WAS NOTICED IN THE PROXIMAL AREA OF THE LAD. A 4.0 X 16MM TAXUS STENT DEPLOYED AT 12 ATMS WAS PLACED OVERLAPPING THE 2.75 X 38MM TAXUS LIBERTE WITH NO ISSUES. A SECOND 4.0 X 12MM TAXUS STENT WAS DEPLOYED AT 12 ATMS COVERING THE AREA OF "DISRUPTION" IN THE PROXIMAL LAD TO COMPLETE THE PROCEDURE. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 APEX MONORAIL CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC - MAPLE GROVE H7493895912300

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention 185CM KINETIX STRAIGHT GUIDE WIRE| 330CM ROTAWIRE GUIDE WIRE| 1.75MM ROTALINK BURR CATHETER| 1.5MM ROTALINK PLUS