BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAVERICK2 MONORAIL PTCA CATHETER

    MDR report key: 1456664 · Received August 27, 2009

    Report

    Report Number
    2134265-2009-04233
    Event Type
    Injury
    Date Received
    August 27, 2009
    Date of Event
    July 21, 2009
    Report Date
    July 28, 2009
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LOX
    PMA / PMN Number
    P860019/S179
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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.

    Description of Event or Problem · 1

    CLINICAL TRIAL. IT WAS REPORTED THAT DURING A CORONARY ARTERY DRUG ELUTING STENTING TREATMENT PROCEDURE, A VESSEL DISSECTION OCCURRED. THE PATIENT WAS DIAGNOSED WITH SILENT ISCHEMIA UNDERWENT CARDIAC CATHETERIZATION. A NON-TARGET LESION LOCATED IN THE 1ST DIAGONAL WAS TREATED PRIOR TO THE TARGET LESION. FOLLOWING SUCCESSFUL TREATMENT OF THE NON-TARGET VESSEL, ATTENTION WAS TURNED TO THE TARGET LESION LOCATED IN THE RAMUS. THE RAMUS WAS PRE-DILATED ONCE WITH A 2.0X12MM MAVERICK 2 RX WHICH RESULTED IN A DISSECTION AND OCCLUSION OF THE TARGET VESSEL. THE PATIENT BECAME HYPOTENSIVE AND WAS TREATED WITH MEDICATION. THE PATIENT DID NOT RECEIVE A STUDY STENT AND THE AREA WAS FURTHER TREATED WITH THE 2.0X12MM MAVERICK 2 RX WITH 90% RESIDUAL STENOSIS. THE PATIENT HAD COMPLAINTS OF CHEST PAIN PROCEDURE, WITH CARDIAC ENZYME ELEVATION CONSISTENT WITH PROTOCOL DEFINITION OF MI. THE PATIENT WAS DISCHARGED TWO DAYS POST PROCEDURE ON ASPIRIN AND CLOPIDOGREL. THE PATIENT IS RECOVERING AND THE EVENTS ARE RESOLVING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAVERICK2 MONORAIL PTCA CATHETER LOX CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC CORPORATION MAVERICK2 12/2.0

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention