BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2862288 · Received December 7, 2012

    Report

    Report Number
    2024168-2012-07732
    Event Type
    Malfunction
    Date Received
    December 7, 2012
    Date of Event
    November 15, 2012
    Report Date
    November 15, 2012
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR ANALYSIS. THE STENT DAMAGE WAS ABLE TO BE CONFIRMED. THE FAILURE TO ADVANCE AND DIFFICULTY REMOVING THE STENT DELIVERY SYSTEM COULD NOT BE REPLICATED IN A TESTING ENVIRONMENT AS IT WAS BASED ON OPERATIONAL CIRCUMSTANCES. BASED ON A VISUAL AND DIMENSIONAL INSPECTION OF THE RETURNED DEVICE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. THE RESULTS OF THE QUERY OF SIMILAR INCIDENTS IN THE COMPLAINT HANDLING DATABASE FOR THIS LOT DID NOT INDICATE A MANUFACTURING ISSUE. IT SHOULD BE NOTED THAT THE XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM INSTRUCTIONS FOR USE (IFU) STATES: 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. BASED ON THE REVIEWED INFORMATION, NO PRODUCT DEFICIENCY WAS IDENTIFIED.

    Additional Manufacturer Narrative · 1

    (B)(4). RE-INSERTION. THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TARGET LESION WAS A CHRONIC TOTAL OCCLUSION (CTO) LOCATED IN THE DISTAL LEFT ANTERIOR DESCENDING ARTERY (LAD) WITH HEAVY TORTUOSITY AND HEAVY CALCIFICATION. THE LESION WAS PREDILATED WITH A 2.0 X 20 MM TREK BALLOON. THEN THE 2.5 X 18 MM XIENCE V STENT WAS ATTEMPTED, BUT IT DID NOT CROSS THE LESION, DUE TO HEAVY CALCIFICATION. THE LESION WAS DILATED AGAIN WITH THE SAME TREK BALLOON. THE SAME XIENCE V STENT WAS ATTEMPTED AGAIN, BUT IT DID STILL DID NOT CROSS. RESISTANCE WAS ENCOUNTERED DURING REMOVAL, BUT FORCE WAS NOT APPLIED. WHEN THE DEVICE WAS OBSERVED OUTSIDE THE ANATOMY, IT WAS NOTED THAT STENT STRUTS WERE FLARED. A NON-ABBOTT BARE METAL STENT WAS THEN ATTEMPTED, BUT IT ALSO DID NOT CROSS THE LESION AND THE PROCEDURE WAS CONCLUDED WITHOUT IMPLANTING A STENT. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. 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 2020941

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR