BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2082435 · Received May 10, 2011

    Report

    Report Number
    2024168-2011-03337
    Event Type
    Malfunction
    Date Received
    May 10, 2011
    Date of Event
    April 8, 2011
    Report Date
    April 12, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: EVALUATION OF THE RETURNED XIENCE V STENT DELIVERY SYSTEM (SDS) NOTED BLOOD VISIBLE IN THE GUIDE WIRE LUMEN, TIP AND ON THE ENTIRE LENGTH OF THE SDS, CONSISTENT WITH THE SDS ADVANCED OVER A GUIDE WIRE INTO THE PATIENT ANATOMY. THE STENT IMPLANT WAS STATIONARY ON THE TIGHTLY FOLDED BALLOON BETWEEN THE MARKERS. THERE WERE STRETCHED STRUTS IN THE FIRST AND SECOND ROWS OF THE DISTAL END OF THE STENT IMPLANT, CONFIRMING THE REPORTED INFORMATION. THE TIP LENGTH AND STENT OUTER DIAMETERS WERE MEASURE AND MET MANUFACTURING CRITERIA. 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. THE PATIENT ANATOMY WAS HEAVILY CALCIFIED WHICH LIKELY CONTRIBUTED TO THE FAILURE TO ADVANCE AND STENT DAMAGE AS THERE WAS NO DAMAGE NOTED TO THE STENT PRIOR TO USE WHICH MAY SUGGEST THAT A PRODUCT DEFICIENCY DID NOT CONTRIBUTE TO THE DIFFICULTIES EXPERIENCED DURING THE PROCEDURE. IT IS LIKELY THAT THE STENT CAUGHT ON THE LESION/ANATOMY DURING ADVANCEMENT DAMAGING THE DISTAL STRUTS, AND FURTHER INTERACTION WITH THE LESION/ANATOMY OR GUIDING CATHETER DURING RETRACTION WOULD HAVE CONTRIBUTED TO THE DAMAGE NOTED AND RESISTANCE DURING RETRACTION. 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 THIS LOT. THERE IS NO INDICATION OF A LOT SPECIFIC PRODUCT QUALITY DEFICIENCY. THE REPORTED DIFFICULTIES APPEAR TO BE RELATED TO THE OPERATIONAL CONTEXT OF THE PROCEDURE. THE PROFILE DIMENSIONS ON ALL STENT DELIVERY SYSTEMS ARE CONFIRMED BY VISUAL AND DIMENSIONAL CHECKS ON THE MANUFACTURING LINE AT ABBOTT VASCULAR. ADDITIONALLY, ALL STENT DELIVERY SYSTEMS ARE VISUALLY INSPECTED ONLINE FOR STENT DAMAGE.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CORONARY PROCEDURE OF THE HEAVILY CALCIFIED, OBTUSE MARGINAL ARTERY, THE XIENCE V STENT DELIVERY SYSTEM (SDS) MET RESISTANCE DURING ADVANCING AND DID NOT CROSS THE LESION. THE SDS ALSO MET RESISTANCE DURING REMOVAL. ONCE OUTSIDE THE ANATOMY THE STENT IMPLANT DISTAL STRUT WAS FOUND TO BE FLARED. THERE WAS NO ADVERSE PATIENT EFFECT REPORTED. THOUGH REQUESTED, 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 0101241

    Patients

    Seq Age Sex Outcome Treatment
    1