BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HI-TORQUE WHISPER GUIDE WIRE

    MDR report key: 3112544 · Received May 14, 2013

    Report

    Report Number
    2024168-2013-03051
    Event Type
    Injury
    Date Received
    May 14, 2013
    Date of Event
    March 12, 2013
    Report Date
    April 29, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    DQX
    PMA / PMN Number
    K101116
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IT IS INDICATED THAT THE DEVICE IS NOT RETURNING FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE LOT HISTORY RECORD AND COMPLAINT HISTORY OF THE REPORTED LOT COULD NOT BE CONDUCTED BECAUSE THE LOT NUMBER WAS NOT PROVIDED. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. IT SHOULD BE NOTED THE HI-TORQUE GUIDE WIRE INSTRUCTIONS FOR USE STATES: USE EXTREME CAUTION WHEN MOVING A GUIDE WIRE THROUGH A NON-ENDOTHELIZED STENT, OR THROUGH STENT STRUTS INTO A BIFURCATED VESSEL. USE OF THIS TECHNIQUE CARRIES ADDITIONAL PATIENT RISKS, INCLUDING THE RISK THAT THE WIRE MAY BECOME CAUGHT ON THE STENT STRUT. IT IS LIKELY THAT THE RESISTANCE NOTED DURING ADVANCEMENT OF THE BALLOON CATHETER AND REMOVAL OF THE GUIDE WIRE OCCURRED AS A RESULT OF INADVERTENT INTERACTIONS WITH THE DEPLOYED STENT STRUTS. FURTHERMORE, THE STENT IMPLANT LIKELY BECAME DAMAGED WHEN THE GUIDING CATHETER AND MICRO-CATHETER PUSHED INTO IT DURING THE ATTEMPTED REMOVAL OF THE JAILED GUIDE WIRE. A CONCLUSIVE CAUSE FOR THE PATIENT EFFECT OF COMA AND THE RELATIONSHIP TO THE DEVICE IF ANY CANNOT BE DETERMINED. THE XIENCE PRIME REFERENCED IS BEING FILED UNDER A SEPARATE MEDWATCH REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT LESIONS IN THE MID LEFT ANTERIOR DESCENDING (LAD) ARTERY AND IN THE PROXIMAL DIAGONAL VESSEL, BOTH WITH MILD TORTUOSITY AND HEAVY CALCIFICATION. TWO GUIDE WIRES WERE INSERTED INTO THE LAD AND DIAGONAL TO PREVENT OBSTRUCTION AFTER STENTING OVER DIAGONAL. A LONG XIENCE PRIME STENT WAS IMPLANTED IN THE MID LAD AND ANOTHER XIENCE PRIME STENT WAS IMPLANTED OVERLAPPING AT THE PROXIMAL LAD. BLOOD FLOW WAS GOOD. THE GUIDE WIRE IN THE DIAGONAL WAS PULLED BACK AND INSERTED AGAIN INTO THE DIAGONAL, THROUGH THE STENT STRUTS, TO PERFORM KISSING BALLOON TECHNIQUE. DURING ADVANCEMENT OF THE BALLOON CATHETER, SEVERE RESISTANCE WAS NOTED WITH THE STENT STRUTS; THEREFORE, THE BALLOON CATHETER WAS REMOVED. DURING AN ATTEMPT TO REMOVE THE GUIDE WIRE, RESISTANCE WAS NOTED AND IT WAS THOUGHT THAT THE GUIDE WIRE WAS JAILED INSIDE THE STENT STRUTS. WHILE TRYING TO REMOVE THE GUIDE WIRE, THE GUIDING CATHETER AND MICRO-CATHETER PUSHED THE PROXIMAL PART OF THE STENT STRUTS SEVERAL TIMES, AND THE STENT STRUTS BECAME DAMAGED, DUE TO AN ACCORDION EFFECT. IT WAS NOTED THAT THE LAD WAS TRANSFORMED DUE TO STENT DEFORMATION. THE PATIENT WAS TRANSFERRED TO CARDIAC SURGERY AND THE STENT AND GUIDE WIRE WERE REMOVED SUCCESSFULLY; HOWEVER, THE PATIENT WENT INTO A COMA FOR A MONTH. THE PATIENT IS NOW RECOVERING IN THE HOSPITAL. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    213249 HI-TORQUE WHISPER GUIDE WIRE GUIDE WIRES DQX AV-TEMECULA-CT

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R STENT: XIENCE PRIME