BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2023665 · Received March 18, 2011

    Report

    Report Number
    2024168-2011-01812
    Event Type
    Malfunction
    Date Received
    March 18, 2011
    Date of Event
    February 16, 2011
    Report Date
    February 17, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, 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. ANALYSIS OF THE RETURNED PRODUCT NOTED BLOOD AND CONTRAST VISIBLE ON THE BALLOON, STENT, AND CONTRAST IN THE INFLATION LUMEN, CONSISTENT WITH HANDLING AND PREPARATION. THE STENT WAS STATIONARY ON THE TIGHTLY FOLDED BALLOON BETWEEN THE MARKERS WITH NO DAMAGE NOTED. THERE WAS NO LINT OBSERVED ON THE STENT DELIVERY SYSTEM (SDS). RETURN ANALYSIS WAS UNABLE TO CONFIRM THE REPORTED INFORMATION AS THERE WAS NO LINT OBSERVED ON THE SDS. POSSIBLE SOURCES FOR FOREIGN MATERIAL INCLUDE BUT ARE NOT LIMITED TO MANUFACTURING, HANDLING DURING SHIPMENT, DISTRIBUTION, OR AT THE ACCOUNT. TO ENSURE THAT FOREIGN MATERIAL IS NOT A RESULT OF MANUFACTURING, ALL SDS ARE INSPECTED FOR CONTAMINATION THROUGHOUT THE MANUFACTURING PROCESS, INCLUDING THE POINT WHERE THE CATHETER IS PLACED IN THE COIL DISPENSER. 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 INCIDENT AND ALL LOT RELEASE TESTING MET MANUFACTURING CRITERIA. ADDITIONALLY, A QUERY OF THE COMPLAINT-HANDLING DATABASE WAS PERFORMED AND THERE HAS BEEN NO SIMILAR INCIDENTS REPORTED FOR FOREIGN MATERIAL FOR THIS LOT. THERE IS NO INDICATION OF A LOT SPECIFIC PRODUCT QUALITY DEFICIENCY. IN THIS CASE, THE REPORTED FOREIGN MATERIAL WAS UNABLE TO BE CONFIRMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN THE XIENCE V PACKAGE WAS OPENED AND THE DEVICE WAS INSPECTED, A PIECE OF LINT, DESCRIBED AS WHITE, SMOOTH/SOFT AND VERY SMALL ABOUT 1-2 MM, WAS OBSERVED ON THE STENT DELIVERY SYSTEM. THE DEVICE NEVER ENTERED THE BODY AND THERE WAS NO PATIENT INVOLVEMENT. 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 0090741

    Patients

    Seq Age Sex Outcome Treatment
    1