BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VOYAGER RX CORONARY DILATATION CATHETER

    MDR report key: 1980510 · Received February 7, 2011

    Report

    Report Number
    2024168-2011-00728
    Event Type
    Injury
    Date Received
    February 7, 2011
    Date of Event
    January 13, 2011
    Report Date
    January 13, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LOX
    PMA / PMN Number
    P810046
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THERE WAS NO REPORTED PRODUCT DEFICIENCY. THE REPORTED PATIENT EFFECT OF PERFORATION, AS LISTED IN THE RX VOYAGER INSTRUCTIONS FOR USE, IS A KNOWN ADVERSE EVENT ASSOCIATED WITH CORONARY ANGIOPLASTY PROCEDURES. PERFORATIONS CAN BE INFLUENCED BY SEVERAL FACTORS INCLUDING, BUT NOT LIMITED TO, LESION CHARACTERISTICS, PROCEDURAL TECHNIQUE, AND DEVICE SIZE SELECTION. THE ADDITIONAL THERAPY APPEARS TO BE A SECONDARY EFFECT OF THE PERFORATION AS A GRAFTMASTER STENT WAS IMPLANTED TO SEAL THE PERFORATION. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS AND THE RELATIONSHIP TO THE DEVICE, IF ANY, CANNOT BE DETERMINED, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PERFORATION OCCURRED DURING PREDILATATION OF THE LESION IN THE SAPHENOUS VEIN GRAFT TO THE LEFT ANTERIOR DESCENDING ARTERY, WITH A 3.5 X 20 RX VOYAGER. A 3.0 X 18 MM XIENCE V WAS DEPLOYED IN AN ATTEMPT TO TREAT THE PERFORATION; HOWEVER, IT DID NOT SEAL THE PERFORATION. A GRAFTMASTER STENT WAS DEPLOYED TO SEAL THE PERFORATION SUCCESSFULLY. THE PROCEDURE CONTINUED WITH THE SUCCESSFUL PLACEMENT OF TWO 3.0 X 28 MM XIENCE V STENTS. THE PATIENT IS REPORTED TO BE WELL. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VOYAGER RX CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA-CT

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention