BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2132515 · Received June 17, 2011

    Report

    Report Number
    2024168-2011-04292
    Event Type
    Injury
    Date Received
    June 17, 2011
    Date of Event
    May 24, 2011
    Report Date
    May 25, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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. EVALUATION SUMMARY: EVALUATION OF THE RETURNED XIENCE STENT DELIVERY SYSTEM (SDS) FOUND BLOOD VISIBLE IN THE GUIDE WIRE LUMEN AND CONTRAST IN THE INFLATION LUMEN, CONSISTENT WITH PREPARATION AND THE SDS ADVANCED OVER A GUIDE WIRE. THE STENT IMPLANT WAS STATIONARY ON THE TIGHTLY FOLDED BALLOON BETWEEN THE MARKERS WITH NO DAMAGE NOTED. THE SDS WAS RETURNED ROLLED ON ITSELF CAUSING THE HYPOTUBE TO BE BENT SEVERAL TIMES THROUGH OUT ITS FULL LENGTH. THE TIP LENGTH AND STENT OUTER DIAMETERS WERE MEASURED 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 TORTUOUS AND CALCIFIED WHICH LIKELY CONTRIBUTED TO THE SDS UNABLE TO CROSS THE LESION. THE PROFILE DIMENSIONS ON ALL STENT DELIVERY SYSTEMS ARE CONFIRMED BY VISUAL AND DIMENSIONAL CHECKS ON THE MANUFACTURING LINE BEFORE RELEASE. THE REPORTED PERFORATION IS A KNOWN ADVERSE EVENT LISTED IN THE XIENCE V INSTRUCTIONS FOR USE. A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS AND THE RELATIONSHIP TO THE DEVICE, IF ANY, CANNOT BE DETERMINED. 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 IS NO LOT SPECIFIC PRODUCT QUALITY DEFICIENCY. THE REPORTED FAILURE TO ADVANCE APPEARS TO BE RELATED TO THE OPERATIONAL CONTEXT OF THE PROCEDURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A STENTING PROCEDURE IN THE MID RIGHT CORONARY ARTERY, TWO XIENCE V STENTS, 3.0 X 28 AND 3.0 X 15 DID NOT CROSS THE HEAVILY TORTUOUS AND HEAVILY CALCIFIED LESION. AFTER ATTEMPTING TO CROSS THE LESION, A PERFORATION WAS NOTED. THE LESION WAS CROSSED AND STENTED WITH AN ADDITIONAL XIENCE V 3.0 X 15 TO TREAT PERFORATION AND COMPLETE THE PROCEDURE. ECHOCARDIOGRAM WAS PERFORMED BUT DID NOT SHOW ANY BLEEDING. THERE WAS NO PROLONGED HOSPITALIZATION REPORTED. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA. THOUGH REQUESTED, THERE WAS NO ADDITIONAL INFORMATION 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 1010441

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention XIENCE V 3.0 X 28