BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2171632 · Received July 21, 2011

    Report

    Report Number
    2024168-2011-05068
    Event Type
    Malfunction
    Date Received
    July 21, 2011
    Date of Event
    May 2, 2011
    Report Date
    June 20, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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. EVALUATION SUMMARY: ANALYSIS OF THE RETURNED PRODUCT NOTED BLOOD VISIBLE IN THE GUIDE WIRE LUMEN AND ON THE BALLOON, SHAFT AND CONTRAST IN THE BALLOON AND ON THE SHAFT, CONSISTENT WITH PREPARATION AND THE STENT DELIVERY SYSTEM (SDS) ADVANCED INTO THE PATIENT ANATOMY. THE STENT IMPLANT WAS DISLODGED FROM THE BALLOON AND WAS RETURNED ON A NON-ABBOTT GUIDE WIRE. THERE WERE STRETCHED STRUTS IN THE FIRST ROW OF THE DISTAL END OF THE STENT IMPLANT. THERE WAS A FLARED STRUT IN THE FIRST ROW OF THE PROXIMAL END OF THE STENT IMPLANT. CRIMP MARKS WERE VISIBLE ON THE TIGHTLY FOLDED BALLOON BETWEEN THE MARKERS, SUGGESTING THAT THE STENT WAS ORIGINALLY POSITIONED CORRECTLY AND SECURELY AT THE TIME OF MANUFACTURE. A NON-ABBOTT GUIDE WIRE WAS RETURNED WITH BLOOD ON THE BLACK POLYMER COATING AND CORE. THERE WAS A KINK IN THE TIP 1.8 CM PROXIMAL TO THE TIP BALL. THERE WAS A BEND IN THE CORE 21.3 CM PROXIMAL TO THE PROXIMAL END OF THE BLACK POLYMER COATING. THE TIP LENGTH AND MIDDLE STENT OUTER DIAMETERS WERE MEASURED AND MET MANUFACTURING CRITERIA. THE PROXIMAL AND DISTAL STENT OUTER DIAMETERS WERE NOT MEASURED DUE TO THE DAMAGE NOTED. THE INABILITY TO CROSS A LESION CAN BE AFFECTED BY NUMEROUS FACTORS INCLUDING, BUT NOT LIMITED TO, PATIENT ANATOMICAL MORPHOLOGY, PATIENT DISEASE STATE, PRE-DILATATION STRATEGY, DEVICE PLACEMENT TECHNIQUE, AND ACCESSORY DEVICE SUPPORT. IT IS LIKELY THE STENT DAMAGE OCCURRED DURING THE PROCEDURE AS THERE WAS NO DAMAGE NOTED TO THE STENT PRIOR TO USE WHICH SUGGESTS A PRODUCT DEFICIENCY DID NOT CONTRIBUTE TO THE REPORTED DIFFICULTIES. DAMAGE TO THE DISTAL AND PROXIMAL ENDS OF THE STENT ARE MOST CONSISTENT WITH THAT OF WHICH OCCURS AS A RESULT OF AN INTERACTION BETWEEN THE MOUNTED STENT AND THE ANATOMY AND/OR ACCESSORIES DURING ADVANCEMENT AND RETRACTION OF THE DEVICE. IN THIS CASE, ALTHOUGH THE PATIENT ANATOMICAL INFORMATION WAS NOT REPORTED, IT WAS NOTED THAT SEVERAL OTHER DEVICES WERE UNABLE TO CROSS WHICH SUGGESTS THE ANATOMY WAS DIFFICULT. ADDITIONAL HANDLING DURING PACKING FOR RETURN ANALYSIS LIKELY CONTRIBUTED TO THE STENT DISLODGING FROM THE BALLOON. TO HELP ENSURE THIS TYPE OF DAMAGE IS NOT THE RESULT OF A MANUFACTURING DEFICIENCY, DURING MANUFACTURING, ALL SDS ARE 100% CHECKED FOR STENT DAMAGE AND CRIMPED STENT PROFILE. A REVIEW OF THE PRODUCT MANUFACTURING RECORDS DID NOT REVEAL ANY NON-CONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT AND ALL LOT RELEASE TESTING MET MANUFACTURING CRITERIA. ADDITIONALLY, A QUERY OF THE COMPLAINT-HANDLING DATABASE WAS PERFORMED AND THERE HAVE BEEN NO OTHER INCIDENTS REPORTED FOR STENT DISLODGEMENT FOR THIS LOT. THERE IS NO LOT SPECIFIC PRODUCT QUALITY DEFICIENCY. THE REPORTED DIFFICULTIES APPEAR TO BE RELATED TO THE OPERATIONAL CONTEXT OF THE PROCEDURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE PROCEDURE IN AN UNSPECIFIED VESSEL, THE 3.0X08 RX XIENCE V STENT DELIVERY SYSTEM COULD NOT ADVANCE TO THE TARGET LESION. THE STENT SYSTEM WAS REMOVED FROM THE ANATOMY. THERE WAS NO REPORTED RESISTANCE DURING REMOVAL. A NON-ABBOTT STENT SYSTEM WAS USED SUCCESSFULLY TO TREAT THE TARGET LESION. THERE WAS NO ADVERSE PATIENT EFFECT AND NO SIGNIFICANT CLINICAL DELAY IN THE PROCEDURE. RETURN DEVICE ANALYSIS REVEALED THAT THE 3.0 X 8 XIENCE V DELIVERY SYSTEM WAS RETURNED WITH THE STENT DISLODGED FROM THE BALLOON. ADDITIONAL REPORTED INFORMATION INDICATES THAT THE STENT DISLODGED DURING REMOVAL, OUTSIDE OF THE ANATOMY.

    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 1012041

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR