BEUDAMED
    FDA Adverse Event Injury Summary report: N

    APEX BALLOON CATHETER

    MDR report key: 3112377 · Received May 14, 2013

    Report

    Report Number
    2134265-2013-03813
    Event Type
    Injury
    Date Received
    May 14, 2013
    Date of Event
    April 11, 2013
    Report Date
    May 7, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    LOX
    PMA / PMN Number
    P860019
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). DEVICE EVALUATED BY MFR: 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

    (B)(4). SAME CASE AS MDR#2134265-2013-03095. IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE, VESSEL DISSECTION OCCURRED. THE PATIENT PRESENTED WITH STABLE ANGINA AND WAS REFERRED FOR CARDIAC CATHETERIZATION. THE 95% STENOSED TARGET LESION LOCATED IN THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY (LAD) WAS TREATED WITH PRE-DILATATION USING A 2.5 X 15 MM APEX BALLOON AT 6 AND 10 ATMS PRESSURE. FOLLOWING PRE DILATATION THERE APPEARED TO BE MINIMAL DISSECTION AND MODERATE IMPROVEMENT OF THE TARGET LESION. THE DISSECTION AND THE TARGET LESION WERE THEN TREATED WITH PLACEMENT OF A 2.5 X 20 MM STUDY STENT AND POST DILATATION USING A 3.0 X 15 MM QUANTUM BALLOON. REPEAT ANGIOGRAM REVEALED 10-20% RESIDUAL STENOSIS. ALSO THERE APPEARED TO BE AN INTRUSION OF PLAQUE OR FLAP INTO THE STENT. THE VESSEL WAS THEN ATTEMPTED TO BE REWIRED IN VIEW OF FURTHER POST-DILATATION; HOWEVER, DUE TO THE ACUTE ANGULATION OF THE LAD, RE-CROSSING THE TARGET LESION WITH AN UNSPECIFIED GUIDE WIRE WAS UNSUCCESSFUL. THE GUIDE WIRE WAS PULLED OUT AND REPEAT ANGIOGRAPHY REVEALED PRESENCE OF THROMBUS EVOLVING AT THE END OF THE STENT WITH WORSENING OF STENOSIS POST PROCEDURE FROM 10-20% TO 60% AT THE END OF PROCEDURE. THERE WAS TIMI 3 FLOW DOWN THE TARGET VESSEL, THE PATIENT WAS PAIN FREE, AND ST SEGMENT WAS ISOELECTRIC ON THE ELECTROCARDIOGRAM. THE PATIENT WAS STARTED ON TREATMENT WITH INTEGRILIN. AT THIS POINT A DECISION WAS MADE TO CONTINUE THE PATIENT OVERNIGHT ON MEDICAL MANAGEMENT WITH INTEGRILIN AND INTRAVENOUS NITROGLYCERINE WITH A REPEAT ANGIOGRAM THE NEXT MORNING FOR FURTHER REVIEW. CATHETERIZATION THE NEXT DAY DEMONSTRATED NEAR COMPLETE RESOLUTION OF THE LAD STENT THROMBUS AND A DECISION WAS MADE TO CONTINUE THE PATIENT ON MEDICAL MANAGEMENT. THE PATIENT WAS DISCHARGED ON DUAL ANTIPLATELET THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    212321 APEX BALLOON CATHETER CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC - MAPLE GROVE UNK21

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention