BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2073295 · Received May 1, 2011

    Report

    Report Number
    2024168-2011-03039
    Event Type
    Injury
    Date Received
    May 1, 2011
    Date of Event
    April 5, 2011
    Report Date
    April 5, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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. THERE WAS NO REPORTED PRODUCT DEFICIENCY. THE REPORTED PERFORATION IS LISTED IN THE INSTRUCTION FOR USE (IFU) AS A KNOWN ADVERSE EVENT ASSOCIATED WITH CORONARY STENTING. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECT, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURING, DESIGN OR LABELING AND THE TREATMENT APPEARS TO BE RELATED TO THE OPERATIONAL CONTEXT OF THE PROCEDURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LESION WAS LOCATED IN THE HEAVILY TORTUOUS AND HEAVILY CALCIFIED FIRST OBTUSE MARGINAL. A GUIDE WIRE [UNSPECIFIED] WAS PLACED AND A 3.0 X 15 MM TREK WAS USED FOR PRE-DILATATION. THE 3.5 X 18 MM XIENCE RX CROSSED THE TIGHT LESION AND WAS IMPLANTED AT 14 ATMOSPHERES. AFTER DEPLOYMENT, A PERFORATION WAS NOTED IN THE MID PART OF THE IMPLANTED STENT. A GRAFTMASTER 3.5 X 16 MM WAS PLACED TO SEAL THE PERFORATION. THE PHYSICIAN FEELS THAT A PIECE OF CALCIUM CAUSED THE VESSEL TO PERFORATE WHEN THE STENT WAS IMPLANTED. 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

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention