BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2182932 · Received July 28, 2011

    Report

    Report Number
    2024168-2011-05359
    Event Type
    Injury
    Date Received
    July 28, 2011
    Date of Event
    June 14, 2011
    Report Date
    July 5, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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. PHYSICAL RESISTANCE WHEN ATTEMPTING TO CROSS A LESION CAN BE AFFECTED BY NUMEROUS FACTORS INCLUDING, BUT NOT LIMITED TO, PATIENT ANATOMICAL MORPHOLOGY, PATIENT DISEASE STATE, PRE-DILATATION STRATEGY, PRODUCT PLACEMENT TECHNIQUE, PRODUCT SIZE SELECTION AND ACCESSORY PRODUCT SUPPORT; AND IS TYPICALLY NOT ASSOCIATED WITH A PRODUCT QUALITY DEFICIENCY. THE ANATOMICAL CONDITIONS REPORTED WERE MILDLY CALCIFIED AND THE LESION WAS ATTEMPTED TO BE DIRECT STENTED (NO PRE-DILATATION) WHICH LIKELY CONTRIBUTED TO THE REPORTED RESISTANCE. PRE-DILATATION WAS PERFORMED AND THE SAME XIENCE WAS RE-INSERTED AND SUCCESSFULLY CROSSED THE LESION. IT SHOULD BE NOTED THAT THE INSTRUCTIONS FOR USE (IFU) STATES TO PRE-DILATE THE LESION WITH A PERCUTANEOUS CORONARY ANGIOGRAPHY(PTCA) CATHETER OF APPROPRIATE LENGTH AND DIAMETER FOR THE VESSEL/LESION TO BE TREATED. LIMIT THE LONGITUDINAL LENGTH OF PRE-DILATATION BY THE PTCA BALLOON TO AVOID CREATING A REGION OF VESSEL INJURY THAT IS OUTSIDE THE BOUNDARIES OF THE XIENCE V STENT. THE IFU ALSO STATES THAT AN UNEXPANDED STENT MAY BE RETRACTED INTO THE GUIDING CATHETER ONE TIME ONLY. AN UNEXPANDED STENT SHOULD NOT BE REINTRODUCED INTO THE ARTERY ONCE IT HAS BEEN PULLED BACK INTO THE GUIDING CATHETER. SUBSEQUENT MOVEMENT IN AND OUT THROUGH THE DISTAL END OF THE GUIDING CATHETER SHOULD NOT BE PERFORMED AS THE STENT MAY BE DAMAGED WHEN RETRACTING THE UNDEPLOYED STENT BACK INTO THE GUIDING CATHETER. IN THIS CASE, THE LACK OF PRE-DILATATION AND RE-INSERTION DOES NOT APPEAR TO HAVE DIRECTLY CAUSED OR CONTRIBUTED TO THE REPORTED DISSECTION. AFTER REMOVAL OF THE STENT DELIVERY SYSTEM FROM THE PATIENT, A DISSECTION WAS NOTED IN THE LEFT MAIN. IT SHOULD BE NOTED THAT DISSECTION IS LISTED IN THE IFU AS A KNOWN ADVERSE EVENT. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED DISSECTION AND THE RELATIONSHIP TO THE DEVICE, IF ANY, CANNOT BE DETERMINED, THE PHYSICAL RESISTANCE AND ADDITIONAL THERAPY/ NON-SURGICAL TREATMENT APPEAR TO BE RELATED TO THE PROCEDURE CIRCUMSTANCES AND THERE ARE NO INDICATIONS OF A PRODUCT QUALITY DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ATTEMPT WAS MADE TO DIRECT STENT THE MILDLY CALCIFIED LESION; HOWEVER, THE XIENCE V STENT DELIVERY SYSTEM (SDS) WOULD NOT CROSS. DILATATION WAS THEN PERFORMED AND THE SAME XIENCE V SDS WAS REINSERTED AND WAS ABLE TO CROSS; HOWEVER, AFTER REMOVAL OF THE SDS FROM THE PATIENT, A DISSECTION WAS NOTED IN THE LEFT MAIN. THE DISSECTION WAS TREATED WITH ANOTHER XIENCE V STENT SUCCESSFULLY; HOWEVER, THE DECISION WAS MADE TO CHANGE THE PATIENTS TREATMENT PLAN TO A CORONARY ARTERY BYPASS. NO ADDITIONAL INFORMATION WAS 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 62 YR Required Intervention