BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2063316 · Received April 19, 2011

    Report

    Report Number
    2024168-2011-02741
    Event Type
    Malfunction
    Date Received
    April 19, 2011
    Date of Event
    March 24, 2011
    Report Date
    March 25, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, 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. THE STENT REMAINS IN THE PATIENT. THE LOT NUMBER WAS PROVIDED. A FOLLOW-UP WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). POTENTIAL FACTORS THAT CAN CONTRIBUTE TO STENT DISLODGEMENT INSIDE THE BODY INCLUDE, BUT ARE NOT LIMITED TO, IMPROPER OR INADEQUATE CRIMPING AT THE TIME OF MANUFACTURE, POSITIVE PRESSURE DURING PRODUCT PREPARATION, NEGATIVE PRESSURE DURING SHEATH REMOVAL, FORCED SHEATH REMOVAL, HANDLING OF THE STENT DURING PRODUCT PREPARATION OR FROM AN INTERACTION WITH OTHER DEVICES, THE PATIENT ANATOMY AND/OR A PREVIOUSLY IMPLANTED STENT. IN THIS CASE, RETURN OF THE STENT DELIVERY SYSTEM (SDS) MAY HAVE AIDED IN DETERMINING A CAUSE FOR THE REPORTED DISLODGEMENT. HOWEVER, SINCE THERE WAS NO NOTE OF ANY DAMAGE OBSERVED TO THE SDS OR STENT IMPLANT PRIOR TO THE PROCEDURE, THIS MAY SUGGEST THAT A PRODUCT DEFICIENCY DID NOT CONTRIBUTE TO THE STENT DISLODGEMENT. IT IS POSSIBLE THAT THE SDS INTERACTED WITH OTHER DEVICES AND/OR THE PATIENT ANATOMY DURING AN ATTEMPT TO POSITION THE STENT, SUCH THAT THE STENT BECAME DISRUPTED ON THE BALLOON AND DISLODGED AS A RESULT, ALTHOUGH THIS CANNOT BE CONFIRMED. TO ENSURE THIS TYPE OF OCCURRENCE IS NOT A RESULT OF A POTENTIAL MANUFACTURING DEFICIENCY, ALL STENT DELIVERY SYSTEMS ARE 100% VISUALLY INSPECTED ONLINE FOR STENT PLACEMENT/SECURITY AND DIMENSIONALLY INSPECTED TO VERIFY THE CRIMPED STENT OUTER DIAMETERS. A SAMPLING OF UNITS IS ALSO SUBJECT TO A STENT MOVEMENT TEST TO VERIFY STENT SECURITY. IN THIS INSTANCE, BASED ON THE INFORMATION RECEIVED WITH THIS COMPLAINT AND WITHOUT THE PRODUCT TO EXAMINE, A DEFINITIVE CAUSE FOR THE REPORTED STENT DISLODGEMENT CANNOT BE DETERMINED. THIS TYPE OF REPORTED EVENT WILL CONTINUE TO BE MONITORED. A REVIEW OF THE FINISHED PRODUCT LOT HISTORY RECORD DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT AND ALL LOT RELEASE TESTING MET MANUFACTURING CRITERIA. ADDITIONALLY, A QUERY OF THE COMPLAINT-HANDLING DATABASE DID NOT REVEAL ANY OTHER INCIDENTS REPORTED FOR STENT DISLODGEMENT, SUGGESTING THAT THERE ARE NO LOT SPECIFIC PRODUCT QUALITY DEFICIENCIES.

    Description of Event or Problem · 1

    SUBSEQUENT TO THE INITIAL MDR FILING, THE FOLLOWING ADDITIONAL INFORMATION WAS RECEIVED. THE PHYSICIAN REPORTS THAT THE PATIENT'S ANATOMY WAS TORTUOUS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LESION WAS IN THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY. THE STENT DISLODGED DURING USE WHEN IT WAS BEING POSITIONED AT THE TARGET LESION. THE STENT WAS ABLE TO BE DEPLOYED IN THE TARGET LESION USING THE STENT DELIVERY SYSTEM BALLOON. NO ADVERSE 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 1011841

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR