BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1961764 · Received January 14, 2011

    Report

    Report Number
    2024168-2011-00307
    Event Type
    Malfunction
    Date Received
    January 14, 2011
    Date of Event
    December 20, 2010
    Report Date
    December 20, 2010
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MY
    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. DILATATION CATHETER: VOYAGER RX; GUIDE WIRE: ATW; GUIDE CATH: LAUNCHER EBU 3.5. EVALUATION SUMMARY: EVALUATION OF THE RETURNED XIENCE V RX STENT DELIVERY SYSTEM (SDS) NOTED BLOOD VISIBLE IN THE GUIDE WIRE LUMEN AND CONTRAST IN THE BALLOON, WHICH IS CONSISTENT WITH PREPARATION AND THE SDS AT LEAST PARTIALLY ADVANCED OVER A GUIDE WIRE. THE STENT WAS RETURNED LOOSE AND BACKWARDS ON THE BALLOON. THERE WERE FLARED STRUTS IN THE FIRST TWO ROWS OF PROXIMAL STRUTS. THERE WERE BENT STRUTS IN THE FIRST SEVEN ROWS OF DISTAL STRUTS. 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. THERE WAS BALLOON PEELING WHERE THE STENT HAD BEEN CRIMPED CORRECTLY BETWEEN THE MARKERS. THE SOFT TIP WAS NOTED TO BE SMASHED. SINCE THIS DAMAGE WAS NOT REPORTED IN THE INCIDENT INFORMATION, THE SMASHED TIP MAY HAVE OCCURRED DURING THE PROCEDURE OR DURING PACKAGING, HANDLING AND RETURN TO ABBOTT VASCULAR FOR ANALYSIS. ADDITIONALLY, THERE WERE STRANDS OF FIBER ENTWINED ON THE SECOND AND FIFTH ROWS OF DISTAL STRUTS. IT IS POSSIBLE THE STENT CAME IN CONTACT WITH A CLOTH DURING PACKAGING, HANDLING AND RETURN TO ABBOTT VASCULAR FOR ANALYSIS AS THERE WAS NO MENTION OF ANY FIBERS DURING THE INSPECTION PRIOR TO USE. THE MIDDLE STENT OUTER DIAMETERS WERE MEASURED AND MET MANUFACTURING CRITERIA. THE PROXIMAL AND DISTAL MEASUREMENTS COULD NOT BE TAKEN DUE TO THE DAMAGE NOTED. STENT DISLODGEMENT CAN BE INFLUENCED BY MANY FACTORS, INCLUDING, BUT NOT LIMITED TO; IMPROPER OR INADEQUATE CRIMPING AT THE TIME OF MANUFACTURE, INCORRECT SHEATH SIZING, POSITIVE PRESSURE DURING PREPARATION, NEGATIVE PRESSURE DURING SHEATH REMOVAL, FORCED SHEATH REMOVAL, HANDLING OF THE STENT DURING PREPARATION, AND INTERACTION WITH THE LESION, ACCESSORY DEVICES, AND/OR PREVIOUSLY IMPLANTED STENTS. IT IS POSSIBLE THERE WAS AN OBSTRUCTION IN THE GUIDING CATHETER, RESULTING IN THE DAMAGE NOTED TO THE STENT, AS THERE WAS NO DAMAGE NOTED TO THE STENT PRIOR TO USE. FURTHER MANIPULATION OF THE SDS AND STENT WITH THE GUIDING CATHETER WOULD HAVE CONTRIBUTED TO THE STENT ULTIMATELY DISLODGING; HOWEVER, WITH OUT THE GUIDING CATHETER TO EXAMINE, THIS COULD NOT BE CONFIRMED. THE DISLODGED STENT WAS LIKELY PLACED BACK ON THE SDS BACKWARDS FOR RETURN ANALYSIS WHICH COULD HAVE FURTHER DAMAGED THE STENT AND CONTRIBUTED TO THE NOTED BALLOON PEELING. A REVIEW OF THE PRODUCT MANUFACTURING RECORDS DID NOT REVEAL ANY NON-CONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT AND ALL LOT RELEASE TESTING MET MANUFACTURING CRITERIA. THERE IS NO INDICATION OF A LOT SPECIFIC PRODUCT QUALITY DEFICIENCY. A CONCLUSIVE CAUSE FOR THE REPORTED STENT DISLODGEMENT COULD NOT BE DETERMINED. ALL STENT DELIVERY SYSTEMS ARE 100% VISUALLY INSPECTED ONLINE FOR STENT PLACEMENT. ADDITIONALLY, A SAMPLING OF UNITS IS DESTRUCTIVELY TESTED TO VERIFY STENT DISLODGEMENT FORCE.

    Additional Manufacturer Narrative · 1

    (B)(4). DATE RECEIVED BY MANUFACTURER: G4 DATE ON INITIAL REPORT SHOULD HAVE BEEN (B)(6) 2010 AND NOT (B)(6) 2011 AS REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER PLACEMENT OF A NON-ABBOTT GUIDING CATHETER, DIRECT STENTING WAS ATTEMPTED TO BE PERFORMED; HOWEVER, THE 3.5 X 23 MM XIENCE V STENT DISLODGED INSIDE THE GUIDING CATHETER. THE DISLODGED STENT WAS ABLE TO BE REMOVED ALONG WITH THE GUIDING CATHETER. THE PROCEDURE WAS RESTARTED AGAIN WITH THE SAME GUIDING CATHETER, FOLLOWED BY PRE-DILATATION USING A VOYAGER BALLOON. STENTING WAS PERFORMED WITH A 3.0 X 23 MM XIENCE V. RESISTANCE WAS FELT WHEN PUSHING THE STENT INTO THE VESSEL, BUT THE STENT WAS ABLE TO BE DEPLOYED. NO PATIENT EFFECTS WERE REPORTED. 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 0031241

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR