BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1930624 · Received December 16, 2010

    Report

    Report Number
    2024168-2010-02784
    Event Type
    Malfunction
    Date Received
    December 16, 2010
    Date of Event
    November 21, 2010
    Report Date
    November 22, 2010
    Manufacturer
    AV-CLONMEL
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    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 DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: ANALYSIS OF THE RETURNED PRODUCT NOTED BLOOD IN THE GUIDE WIRE LUMEN AND ON THE ENTIRE LENGTH OF THE STENT DELIVERY SYSTEM (SDS), WHICH IS CONSISTENT WITH A GUIDE WIRE BEING LOADED INTO THE LUMEN AND THE SDS ADVANCED INTO THE BODY. THE STENT DISLODGEMENT WAS NOT CONFIRMED, AS THE STENT IMPLANT WAS STATIONARY ON THE TIGHTLY FOLDED BALLOON BETWEEN THE MARKERS. HOWEVER, THERE WERE STRETCHED AND FLARED STRUTS IN THE DISTAL END OF THE STENT IMPLANT. SINCE THERE WAS NO REPORT OF ANY DAMAGE OBSERVED TO THE STENT IMPLANT PRIOR TO THE PROCEDURE, THIS MAY SUGGEST THAT A PRODUCT DEFICIENCY DID NOT CONTRIBUTE TO THE REPORTED STENT DAMAGE. THIS TYPE OF STENT DAMAGE IS 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 OF THE PRODUCT AND/OR AS A RESULT OF AN INTERACTION BETWEEN THE MOUNTED STENT AND THE TIP OF THE GUIDING CATHETER AND/OR RHV DURING RETRACTION OF THE PRODUCT. THERE WERE MULTIPLE KINKS THROUGHOUT THE ENTIRE LENGTH OF THE HYPOTUBE. THIS DAMAGE WAS NOT OBSERVED DURING PRODUCT INSPECTION PRIOR TO USE AND THUS, MAY HAVE OCCURRED DURING OR AFTER THE PROCEDURAL ATTEMPTS TO CROSS THE LESION, OR POSSIBLY AS A RESULT OF PACKAGING AND SHIPMENT BACK TO ABBOTT VASCULAR. THE STENT DISLODGEMENT WAS NOT CONFIRMED, HOWEVER, THE STENT DAMAGE AND KINKS ARE LIKELY RELATED TO OPERATIONAL CONTEXT. A REVIEW OF THE FINISHED DEVICE LOT HISTORY RECORDS DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT AND THERE HAVE BEEN NO RELATED INCIDENTS REPORTED FOR THIS LOT. ALL STENT DELIVERY SYSTEMS ARE 100% INSPECTED FOR PROPER STENT PLACEMENT, STENT DAMAGE, AND CRIMPED STENT OUTER DIAMETER. ADDITIONALLY, A SAMPLING OF UNITS IS DESTRUCTIVELY TESTED PRIOR TO RELEASE TO VERIFY STENT DISLODGEMENT FORCE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE PROCEDURE IN AN UNSPECIFIED VESSEL, THE XIENCE V STENT DISLODGED FROM THE BALLOON, BUT REMAINED ON THE STENT SYSTEM DURING ADVANCEMENT. THERE WAS NO RESISTANCE FELT WHEN ADVANCING THE STENT SYSTEM AND NO FORCE WAS APPLIED. THE STENT SYSTEM WITH THE BALLOON WAS SUCCESSFULLY REMOVED FROM THE PATIENT ANATOMY. ANOTHER XIENCE V STENT SYSTEM WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT. 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-CLONMEL 0052841

    Patients

    Seq Age Sex Outcome Treatment
    1 XIENCE V STENT SYSTEM