BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 3112535 · Received May 14, 2013

    Report

    Report Number
    2024168-2013-03049
    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
    NIQ
    PMA / PMN Number
    P110019
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    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. 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 IDENTIFICATION NUMBERS WERE NOT PROVIDED. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. THE WHISPER GUIDE WIRE REFERENCED IN 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 WHISPER 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
    213139 XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R GUIDE WIRE: WHISPER