BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2131869 · Received June 16, 2011

    Report

    Report Number
    2024168-2011-04276
    Event Type
    Injury
    Date Received
    June 16, 2011
    Date of Event
    May 24, 2011
    Report Date
    May 24, 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). 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 STENT DELIVERY SYSTEM BEING UNABLE TO CROSS THE LESION. 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 THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT AND ALL LOT RELEASE TESTING MET MANUFACTURING CRITERIA. ADDITIONALLY, A QUERY OF SIMILAR INCIDENTS FOR THIS LOT WAS REVIEWED AND THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY.

    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. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION. STENT: XIENCE V 3.0 X 28 MM IS BEING REPORTED UNDER A SEPARATE MEDWATCH REPORT NUMBER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LESION WAS IN THE OSTIUM OF THE RIGHT CORONARY ARTERY (RCA), WITH HEAVY TORTUOUSITY AND HEAVY CALCIFICATION. THE XIENCE 3.0 X 15 MM AND XIENCE 3.0 X 28 MM STENTS BOTH FAILED TO CROSS THE LESION. DURING THE ATTEMPTS, A PERFORATION WAS NOTED. IT IS UNKNOWN WHICH XIENCE STENT WAS BEING ATTEMPTED WHEN THE PERFORATION OCCURRED. ANOTHER 3.0 X 15 MM XIENCE WAS ABLE TO CROSS AND WAS IMPLANTED, TO SEAL THE PERFORATION AS WELL AS TREAT THE LESION. NO FURTHER 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 0110342

    Patients

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