BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2143145 · Received June 28, 2011

    Report

    Report Number
    2024168-2011-04532
    Event Type
    Injury
    Date Received
    June 28, 2011
    Date of Event
    November 18, 2009
    Report Date
    June 3, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, 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. THE ESTIMATED DATE OF THE EVENT WAS REPORTED AS OCCURING PRIOR TO (B)(6), 2011. FACTORS THAT MAY CONTRIBUTE TO STENT FRACTURES INCLUDE, BUT ARE NOT LIMITED TO, PROCESSING AND/OR HANDLING IN MANUFACTURING, HANDLING DURING PREPARATION FOR USE, LESION CHARACTERISTICS, PROCEDURAL TECHNIQUE, PRODUCT SIZE SELECTION, SEVERE TORQUING OR KINKING OF STENT (MATERIAL STRESS/ FATIGUE) OR INTERACTION WITH THE ACCESSORY DEVICES, LESION AND/OR ANATOMY. FATIGUE FROM CARDIAC DYNAMICS AND MOTION MAY ALSO CONTRIBUTE TO STENT FRACTURES DURING OR AFTER THE PROCEDURE. IN THIS CASE, THE STENT FRACTURE WAS NOT NOTED AT THE TIME OF STENT IMPLANT, SUGGESTING THAT THE NOTED DAMAGE OCCURRED POST PROCEDURE. RESTENOSIS, AS LISTED IN THE XIENCE V INSTRUCTIONS FOR USE, IS A KNOWN ADVERSE EVENT ASSOCIATED WITH CORONARY STENTING AND IS NOT NECESSARILY AN INDICATION OF A PRODUCT QUALITY DEFICIENCY. THE REPORTED STENT FRACTURE POSSIBLY CONTRIBUTED TO THE REPORTED RESTENOSIS. HOWEVER, A CONCLUSIVE CAUSE CANNOT BE DETERMINED FOR THE REPORTED PATIENT EFFECTS AND THEIR RELATIONSHIP TO THE DEVICE, IF ANY. ALTHOUGH A CONCLUSIVE CAUSE FOR THE STENT FRACTURE AND ITS RELATIONSHIP TO THE REPORTED PATIENT EFFECTS CANNOT BE DETERMINED, THERE DOES NOT APPEAR TO BE ANY INDICATION OF A PRODUCT QUALITY DEFICIENCY. THE LOT HISTORY RECORD FOR THIS PRODUCT WAS NOT REVIEWED AND A SIMILAR INCIDENT QUERY WAS NOT PERFORMED BECAUSE THE PRODUCT WAS NOT RETURNED FOR ANALYSIS AND THE PART AND LOT NUMBERS WERE NOT REPORTED.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    SUBSEQUENT TO THE INITIAL MEDWATCH REPORT, ADDITIONAL INFORMATION RECEIVED INDICATES THAT THE INDEX STENT WAS IMPLANTED 101 DAYS PRIOR TO THE DEATH, WHICH WOULD BE (B)(6) 2009. ADDITIONALLY, THE STENT FRACTURE WAS REPORTED AS A GRADE V AND THE DATE OF DEATH, FROM THE MOTOR VEHICLE ACCIDENT, INDICATED AS (B)(6) 2009. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT WAS INVOLVED IN A MOTOR VEHICLE ACCIDENT (MVA) WHERE HE WAS THE DRIVER OF A VEHICLE THAT WAS "T-BONED" ON THE DRIVER'S SIDE. THE PATIENT COMPLAINED OF SHORTNESS OF BREATH THEN BECAME UNRESPONSIVE WITH PULSELESS ELECTRICAL ACTIVITY AND DIED. UPON AUTOPSY, IT WAS NOTED THAT THE PATIENT HAD A FRACTURED XIENCE V STENT AND RESTENOSIS IN THE LEFT CIRCUMFLEX OBTUSE MARGINAL BRANCH. DUE TO THE CHANGES NOTED IN THE VESSEL, THE STENT FRACTURE OCCURRED PRIOR TO THE MVA. THE CAUSE OF DEATH WAS DETERMINED AS NOT RELATED TO THE ABBOTT DEVICE. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Other